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Management of paediatric ulcerative colitis, Part 2: acute severe colitis; an evidence-based consensus guideline from ECCO and ESPGHANDan Turner MD PhD1, Frank M. Ruemmele MD PhD2, Esther Orlanski-Meyer MD1, Anne M. Griffiths MD3, Javier Martin de Carpi MD4, Jiri Bronsky MD PhD5, Gabor Veres MD PhD6, Marina Aloi MD PhD7, Caterina Strisciuglio MD PhD 8, Christian P. Braegger MD 9, Amit Assa MD10, Claudio Romano MD11, Séamus Hussey MB FRCPI 12, Michael Stanton MD13, Mikko Pakarinen MD PhD 14, Lissy de Ridder MD PhD 15, Konstantinos H. Katsanos MD16, Nick Croft MD PhD17, Víctor Manuel Navas-López MD, PhD18, David C. Wilson MD19, Sally Lawrence MD20, Richard K. Russell MD PhD21*ALL AUTHORS CONTRIBUTED EQUALLY1Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel; 2 Université Paris Descartes, Sorbonne Paris Cité, APHP, H?pital Necker Enfants Malades, Paris, France; 3 The Hospital for Sick Children, University of Toronto, Canada 4 Hospital Sant Joan de Déu, Barcelona, Spain; 5 Department of Paediatrics, University Hospital Motol, Prague, Czech Republic;6 Ist Dept. of Pediatrics, Semmelweis University, Budapest, Hungary;7 Pediatric Gastroenterology and Liver Unit, Sapienza University of Rome, Italy8 Department of Woman, Child and General and Specialistic Surgery, University of Campania “Luigi Vanvitelli”, Napoli, Italy9 University Children’s Hospital, Zurich, Switzerland10 Schneider Children's Hospital, Petach Tikva, affiliated to the Sackler Faculty of Medicine, Tel Aviv University, Israel11 Pediatric Department, University of Messina, Italy 12 National Children’s Research Centre, Royal College of Surgeons of Ireland and University College Dublin, Ireland; and University College Dublin, Ireland;13 Southampton Children’s Hospital, UK?;14 Helsinki University Children’s Hospital, Department of Pediatric Surgery, Helsinki, Finland;15 Erasmus MC-Sophia Children’s Hospital, Rotterdam, The Netherlands;16 Medical School and University Hospital of Ioannina, Greece17 Barts and the London School of Medicine, Queen Mary University of London, UK;18 Pediatric Gastroenterology and Nutrition Unit. Hospital Materno. IBIMA. Málaga, Spain19 Child Life and Health, University of Edinburgh, UK20 BC Children’s Hospital, University of British Columbia, Vancouver BC, Canada21 The Royal Hospital for Children, Glasgow, UK; Funding: European Crohn's and Colitis Organization (ECCO) and the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN). Conflict of interestsDT- last 3 years received consultation fee, research grant, royalties, or honorarium from Janssen, Pfizer, Hospital for Sick Children (PUCAI royalties from industry trials), Ferring, AstraZeneca, Abbvie, Takeda, Ferring, Boehringer Ingelheim, Biogen, Atlantic Health, Shire, CelgeneJMdC-last 3 years received consultation fee, research grant, travel grant, or honorarium from Abbvie, Abbot, Nestle, MSD, Otsuka, Faes, Nutricia, Fresenius JB received honoraria, speaker’s fees and/or congress fees from AbbVie, MSD, Nestle, Nutricia and Biocodex.GV- received consultation fee from Nestle, Danone and Abbvie.MA last 3 years received honorarium from AbbVieFMR received speaker fees from: Schering-Plough, Nestlé, Mead Johnson, Ferring, MSD, Johnson & Johnson, Centocor, AbbVie; serves as a board member for: SAC:DEVELOP (Johnson & Johnson), CAPE (ABBVIE), LEA (ABBVIE) and has been invited to MSD France, Nestlé Nutrition Institute, Nestlé Health Science, Danone, TAKEDA, CELGENE, BIOGEN, SHIRE, PFIZER, THERAKOSAA- Received research grant from AbbVieSH- received a travel bursary from AbbVieLdR – last 3 years received consultation fee, research grant, or honorarium from ZonMw (national health institute), Janssen, Pfizer, Mundipharma, Shire and AbbvieKK - Honoraria for consulting services (educational services, scientific articles, participation in Advisory Boards, clinical trials, other) from the companies as follows AbbVie, ENORASIS, Ferring, JANNSEN, MSD and TakedaVNL last 3 years received consultation fee or honorarium from Abbvie, Otsuka and Nestlé Health Science SL – last 2 years received honorarium from JanssenRKR has received speaker’s fees, travel support, or has performed consultancy work with Nestlé Health Science, AbbVie, Napp, Celltrion, Shire and Janssen.MS, CS, CB, CR No conflict of interests to declareEO has received honoraria from Abbvie.NC research funding for trials, speaker fees and travel for conferences from Takeda, Shire, Celgene, RocheMP lectures and congress fees sponsored by Astellas, Baxter and Shire.AMG consultancy, speakers fees or research support for Abbvie, Celgene, Ferring, Gilead, Janssen, Pfizer and Takeda. DCW?has received speaker’s fees, travel support, or has performed consultancy work with?Abbvie, Takeda and Falk.ABSTRACT Background and aim: Acute severe colitis (ASC) is one of the few emergencies in paediatric gastroenterology. Tight monitoring and timely medical and surgical interventions may improve outcomes and minimize morbidity and mortality. We aimed to standardize daily treatment of ASC in children through detailed recommendations and practice points which are based on a systematic review of the literature and consensus of experts. Methods: These guidelines are a joint effort of the European Crohn's and Colitis Organization (ECCO) and the European Society of Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). Fifteen predefined questions were addressed by working subgroups. An iterative consensus process, including two face-to-face meetings, was followed by voting by the national representatives of ECCO and all members of the Paediatric Inflammatory Bowel Disease (IBD) Porto group of ESPGHAN (43 voting experts). Results: A total of 24 recommendations and 43 practice points were endorsed with a consensus rate of at least 91% regarding diagnosis, monitoring and management of ASC in children. A summary flowchart is presented based on daily scoring of the Paediatric Ulcerative Colitis Activity Index (PUCAI). Several topics have been altered since the previous 2011 guidelines and from those published in adults. Discussion: These guidelines standardize the management of ASC in children in an attempt to optimize outcomes of this intensive clinical scenario.What is knownThe previously published ESPGHAN-ECCO guidelines on acute severe colitis (ASC) were published in 2011 and are updated herein What is newIn addition to providing an update of new literature, several major topics have changed from the previous guidelines. A PUCAI-based algorithm dictates a day-by-day therapeutic and monitoring management; the use of thrombotic prophylaxis has been revisited based on predicting variables; sequential therapy has been newly presented; recommendations for therapeutic drug monitoring have been provided; and other sections updated. INTRODUCTIONAcute severe ulcerative colitis (ASC), a medical emergency in children, is defined by a paediatric UC activity index (PUCAI) score of at least 65 points PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UdXJuZXI8L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFyPjxS
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AG==
ADDIN EN.CITE.DATA (1-3) (Table 1). Paediatric onset UC is often more extensive than in adults and more dynamic in progression PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HcmlmZml0aHM8L0F1dGhvcj48WWVhcj4yMDA0PC9ZZWFy
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ADDIN EN.CITE.DATA (7). Comparable rates were found in a multicenter paediatric UC inception cohort, in which 15% of children developed ASC within 3 months of diagnosis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TY2hlY2h0ZXI8L0F1dGhvcj48WWVhcj4yMDE1PC9ZZWFy
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TY2hlY2h0ZXI8L0F1dGhvcj48WWVhcj4yMDE1PC9ZZWFy
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ADDIN EN.CITE.DATA (8). In an older population-based retrospective cohort, 28% of children required hospitalization within the first 3 years of disease PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UdXJuZXI8L0F1dGhvcj48WWVhcj4yMDA4PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (9). The difference between the older and newer cohorts possibly reflects the advent of biologics which allow outpatient treatment of some children with UC.With few exceptions, children with ASC should be admitted to hospital for immediate evaluation and intensive medical treatment with intravenous corticosteroids (IVCS). A PUCAI≥65 is associated with a more refractory disease course in paediatric UC, both at disease onset and thereafter PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5TY2hlY2h0ZXI8L0F1dGhvcj48WWVhcj4yMDE1PC9ZZWFy
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ADDIN EN.CITE.DATA (8-10). In a systematic review, the pooled steroid-refractory rate in ASC across all paediatric studies was 34% ADDIN EN.CITE <EndNote><Cite><Author>Turner</Author><Year>2011</Year><RecNum>1610</RecNum><DisplayText>(11)</DisplayText><record><rec-number>1610</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">1610</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Turner, D.</author><author>Griffiths, A. M.</author></authors></contributors><auth-address>Pediatric Gastroenterology Unit, Shaare Zedek Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel. turnerd@.il</auth-address><titles><title>Acute severe ulcerative colitis in children: a systematic review</title><secondary-title>Inflamm Bowel Dis</secondary-title></titles><periodical><full-title>Inflamm Bowel Dis</full-title></periodical><pages>440-9</pages><volume>17</volume><number>1</number><edition>2010/07/21</edition><dates><year>2011</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>1536-4844 (Electronic)
1078-0998 (Linking)</isbn><accession-num>20645317</accession-num><urls><related-urls><url>;(11), slightly higher than the pooled 29% rate found in adult studies ADDIN EN.CITE <EndNote><Cite><Author>Turner</Author><Year>2007</Year><RecNum>334</RecNum><DisplayText>(12)</DisplayText><record><rec-number>334</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">334</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Turner, D.</author><author>Walsh, C. M.</author><author>Steinhart, A. H.</author><author>Griffiths, A. M.</author></authors></contributors><titles><title>Response to corticosteroids in severe ulcerative colitis: a systematic review of the literature and a meta-regression</title><secondary-title>Clin Gastroenterol Hepatol</secondary-title></titles><periodical><full-title>Clin Gastroenterol Hepatol</full-title></periodical><pages>103-10</pages><volume>5</volume><number>1</number><dates><year>2007</year></dates><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>(12). In two paediatric inception cohorts, the occurrence of ASC was associated with an increased risk of colectomy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BbG9pPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA (7, 8). The advent of calcineurin inhibitors and infliximab has reduced the short term colectomy rate from 40-70% PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UdXJuZXI8L0F1dGhvcj48WWVhcj4yMDA3PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (10, 14, 15) and the 1-year colectomy rate from ~60% PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UdXJuZXI8L0F1dGhvcj48WWVhcj4yMDA4PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (17).Mortality in ASC has decreased in adults from over 70% in 1933 to 20-25% in the 1950's when the importance of timely urgent colectomy was first recognized PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYXJkeTwvQXV0aG9yPjxZZWFyPjE5MzM8L1llYXI+PFJl
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYXJkeTwvQXV0aG9yPjxZZWFyPjE5MzM8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (18, 19). Later, the mortality rate was further reduced to 7% with the introduction of IVCS as the mainstay of treatment, and eventually to less than 1% nowadays PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UcnVlbG92ZTwvQXV0aG9yPjxZZWFyPjE5NTU8L1llYXI+
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ADDIN EN.CITE.DATA (1), new data have accumulated regarding management, diagnosis, and outcomes. We thus aimed to update the guidelines for managing ASC in children based on a systematic review of the literature and a robust consensus process from ECCO and the Paediatric IBD Porto group of ESPGHAN. The methods can be found in the beginning of Part 1 of these guidelines. Surgical considerations are also presented in Part 1. INITIAL MANAGEMENTInfectious screeningRecommendationsBacterial causes for ASC should be excluded by a stool culture including Clostridium difficile (C. difficile) toxins A and B [EL4, adult EL3] (100% agreement)Oral vancomycin should be considered as first line therapy for C. difficile infection in severe UC [EL4, adults EL1] (100% agreement)Cytomegalovirus (CMV) colitis should be excluded in children not responding to 3 days of IVCS [EL4, adults EL3] (98% agreement)Other infections should be considered when relevant, including viral and parasitic (e.g. Cryptosporidium and amoebiasis), such as in the presence of fever, other affected household members or non-bloody diarrhea; stool testing for Entamoeba histolytica should be performed in endemic areas or recent travel to these areas [EL4, adults EL4] (100% agreement)Practice pointsIt is important to test for both C. difficile toxin A and B; repeated sampling is required unless a PCR-based test is available- then one stool sample is sufficient (100% agreement). Oral vancomycin for C. difficile should be prescribed for 10-14 days in doses of 10mg/kg per dose 4 times daily up to an adult dose of 125-250mg increased if needed to maximum of 500mg 4 times daily, although national recommendations vary. Oral metronidazole may be used in the absence of oral vancomycin at a dose of 7.5-10mg/kg per dose 3 times daily (to a maximum of 2g/24hrs) for 10-14 days (100% agreement).CMV infection is best identified by obtaining mucosal biopsies via a flexible sigmoidoscopy. Biopsies should be stained using both hematoxylin eosin and immunohistochemistry for CMV. Positive PCR in the absence of inclusion bodies or positive staining is insufficient for diagnosing CMV since PCR lacks specificity (100% agreement). For CMV infection, ganciclovir should be used at a dose of 5 mg/kg twice daily for 21 days. Response is anticipated within a few days and management should be re-considered with an infectious-diseases specialist if this has not been achieved. Switching to oral valganciclovir may be considered after several days of successful intravenous treatment (100% agreement). Many gastrointestinal infections have been associated with paediatric ASC. In one retrospective study, 24% (22/92) of flares in children requiring hospital admission for IBD were associated with some enteric infection ADDIN EN.CITE <EndNote><Cite><Author>Vadlamudi</Author><Year>2013</Year><RecNum>4755</RecNum><DisplayText>(24)</DisplayText><record><rec-number>4755</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803873">4755</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Vadlamudi, N.B.</author><author>Hitch,M.C.</author><author>Thame,K.A.</author><author>Dimmitt,R.A.</author><author>Harrison,K.</author><author>Huisingh,C.</author><author>Maclin,J.S.</author></authors></contributors><titles><title>Enteric Infections In Hospitalized Pediatric Inflammatory Bowel Disease Patients With Relapse</title><secondary-title>The Internet Journal of Paediatrics and Neonatology</secondary-title></titles><periodical><full-title>The Internet Journal of Paediatrics and Neonatology</full-title></periodical><volume>16</volume><number>1</number><dates><year>2013</year></dates><urls></urls></record></Cite></EndNote>(24). Stool bacterial culture was positive in 2% of children admitted for UC exacerbation, as reported in two paediatric cohorts PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SdXNzZWxsPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48
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ADDIN EN.CITE.DATA (24-32), compared with 7.5% per year of follow-up in outpatient paediatric IBD, which may include some asymptomatic carriers PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NYXJ0aW5lbGxpPC9BdXRob3I+PFllYXI+MjAxNDwvWWVh
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ADDIN EN.CITE.DATA (33). A C. difficile rate of 25% was reported in a retrospective study of 81 children admitted with active colonic IBD (compared with 8.9 % in non-IBD controls) ADDIN EN.CITE <EndNote><Cite><Author>Pascarella</Author><Year>2009</Year><RecNum>1536</RecNum><DisplayText>(26)</DisplayText><record><rec-number>1536</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">1536</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Pascarella, F.</author><author>Martinelli, M.</author><author>Miele, E.</author><author>Del Pezzo, M.</author><author>Roscetto, E.</author><author>Staiano, A.</author></authors></contributors><auth-address>Department of Pediatrics, University of Naples Federico II, Naples, Italy.</auth-address><titles><title>Impact of Clostridium difficile infection on pediatric inflammatory bowel disease</title><secondary-title>J Pediatr</secondary-title></titles><periodical><full-title>J Pediatr</full-title></periodical><pages>854-8</pages><volume>154</volume><number>6</number><edition>2009/02/24</edition><keywords><keyword>Adolescent</keyword><keyword>Bacterial Toxins/analysis</keyword><keyword>Child</keyword><keyword>Child, Preschool</keyword><keyword>*Clostridium difficile</keyword><keyword>Enterocolitis, Pseudomembranous/*complications/diagnosis</keyword><keyword>Feces/microbiology</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Infant</keyword><keyword>Inflammatory Bowel Diseases/diagnosis/*microbiology</keyword><keyword>Male</keyword><keyword>Risk Factors</keyword></keywords><dates><year>2009</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>1097-6833 (Electronic)
0022-3476 (Linking)</isbn><accession-num>19230908</accession-num><urls><related-urls><url>(08)01143-8 [pii]
10.1016/j.jpeds.2008.12.039</electronic-resource-num><language>eng</language></record></Cite></EndNote>(26). An administrative database study among adults and children showed that the rate of C. difficile was more than 12 times greater in IBD compared with non-IBD hospitalizations with increasing incidence over time ADDIN EN.CITE <EndNote><Cite><Author>Hourigan</Author><Year>2014</Year><RecNum>4759</RecNum><DisplayText>(29)</DisplayText><record><rec-number>4759</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803874">4759</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hourigan, S. K.</author><author>Oliva-Hemker, M.</author><author>Hutfless, S.</author></authors></contributors><auth-address>Hourigan,S K. Division of Pediatric Gastroenterology and Nutrition, Johns Hopkins School of Medicine, Brady 320, 600 N. Wolfe Street, Baltimore, MD, 21287, USA, suchihourigan@.</auth-address><titles><title>The prevalence of Clostridium difficile infection in pediatric and adult patients with inflammatory bowel disease</title><secondary-title>Digestive Diseases & Sciences</secondary-title></titles><periodical><full-title>Digestive Diseases & Sciences</full-title></periodical><pages>2222-7</pages><volume>59</volume><number>9</number><dates><year>2014</year></dates><accession-num>24788321</accession-num><work-type>Comparative Study</work-type><urls><related-urls><url> Technologies</remote-database-provider></record></Cite></EndNote>(29). In hospitalized paediatric and adult IBD patients C. difficile is associated with increased morbidity including extended hospital stays, colectomy rate, and even mortality PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GdTwvQXV0aG9yPjxZZWFyPjIwMTY8L1llYXI+PFJlY051
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ADDIN EN.CITE.DATA (48).In hospitalized IBD children with C. difficile, 75% responded to metronidazole and the others responded to vancomycin ADDIN EN.CITE <EndNote><Cite><Author>Vadlamudi</Author><Year>2013</Year><RecNum>4755</RecNum><DisplayText>(24)</DisplayText><record><rec-number>4755</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803873">4755</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Vadlamudi, N.B.</author><author>Hitch,M.C.</author><author>Thame,K.A.</author><author>Dimmitt,R.A.</author><author>Harrison,K.</author><author>Huisingh,C.</author><author>Maclin,J.S.</author></authors></contributors><titles><title>Enteric Infections In Hospitalized Pediatric Inflammatory Bowel Disease Patients With Relapse</title><secondary-title>The Internet Journal of Paediatrics and Neonatology</secondary-title></titles><periodical><full-title>The Internet Journal of Paediatrics and Neonatology</full-title></periodical><volume>16</volume><number>1</number><dates><year>2013</year></dates><urls></urls></record></Cite></EndNote>(24). Similarly, a recent RCT of metronidazole vs. rifaximin for treating C. difficile in children with IBD (not with ASC) showed eradication rate of 71% versus 79%, respectively ADDIN EN.CITE <EndNote><Cite><Author>Gawronska</Author><Year>2017</Year><RecNum>5346</RecNum><DisplayText>(49)</DisplayText><record><rec-number>5346</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1517064891">5346</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Gawronska, A.</author><author>Banasiuk, M.</author><author>Lachowicz, D.</author><author>Pituch, H.</author><author>Albrecht, P.</author><author>Banaszkiewicz, A.</author></authors></contributors><auth-address>Departments of *Pediatric Gastroenterology and Nutrition, and daggerMedical Microbiology, Medical University of Warsaw, Warsaw, Poland.</auth-address><titles><title>Metronidazole or Rifaximin for Treatment of Clostridium difficile in Pediatric Patients with Inflammatory Bowel Disease: A Randomized Clinical Trial</title><secondary-title>Inflamm Bowel Dis</secondary-title><alt-title>Inflammatory bowel diseases</alt-title></titles><periodical><full-title>Inflamm Bowel Dis</full-title></periodical><alt-periodical><full-title>Inflammatory Bowel Diseases</full-title></alt-periodical><pages>2209-2214</pages><volume>23</volume><number>12</number><dates><year>2017</year><pub-dates><date>Dec</date></pub-dates></dates><isbn>1536-4844 (Electronic)
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ADDIN EN.CITE.DATA (44, 50-52). Although a Cochrane systematic review showed no difference in efficacy between vancomycin and metronidazole, it was not specific to IBD and most studies excluded severe disease ADDIN EN.CITE <EndNote><Cite><Author>Nelson</Author><Year>2011</Year><RecNum>4771</RecNum><DisplayText>(53)</DisplayText><record><rec-number>4771</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803878">4771</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nelson, R. L.</author><author>Kelsey, P.</author><author>Leeman, H.</author><author>Meardon, N.</author><author>Patel, H.</author><author>Paul, K.</author><author>Rees, R.</author><author>Taylor, B.</author><author>Wood, E.</author><author>Malakun, R.</author></authors></contributors><auth-address>Nelson,Richard L. Department of General Surgery, Northern General Hospital, Herries Road, Sheffield, Yorkshire, UK, S5 7AU.</auth-address><titles><title>Antibiotic treatment for Clostridium difficile-associated diarrhea in adults</title><secondary-title>Cochrane Database of Systematic Reviews</secondary-title></titles><periodical><full-title>Cochrane Database of Systematic Reviews</full-title></periodical><pages>CD004610</pages><number>9</number><dates><year>2011</year></dates><accession-num>21901692</accession-num><work-type>Meta-Analysis
Review</work-type><urls><related-urls><url> Technologies</remote-database-provider></record></Cite></EndNote>(53). A diminished colectomy rate (from 46 to 25%) was reported using vancomycin as primary therapy for C. difficile in hospitalized IBD patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Jc3NhPC9BdXRob3I+PFllYXI+MjAwNzwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA (59). Its use is limited by its high cost compared to vancomycin. There is currently no evidence to support the use of faecal microbial transplantation (FMT) in ASC associated with C. difficile in children or adults. However, FMT is highly effective for eradication of recurrent C. difficile ADDIN EN.CITE <EndNote><Cite><Author>Gough</Author><Year>2011</Year><RecNum>3713</RecNum><DisplayText>(60)</DisplayText><record><rec-number>3713</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1403717594">3713</key><key app="ENWeb" db-id="">0</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Gough, E.</author><author>Shaikh, H.</author><author>Manges, A. R.</author></authors></contributors><auth-address>Department of Epidemiology Biostatistics and Occupational Health, McGill University, 1020 Pine Avenue West, Montreal, Quebec, Canada.</auth-address><titles><title>Systematic review of intestinal microbiota transplantation (fecal bacteriotherapy) for recurrent Clostridium difficile infection</title><secondary-title>Clin Infect Dis</secondary-title><alt-title>Clinical infectious diseases : an official publication of the Infectious Diseases Society of America</alt-title></titles><periodical><full-title>Clin Infect Dis</full-title></periodical><pages>994-1002</pages><volume>53</volume><number>10</number><keywords><keyword>Clostridium Infections/*therapy</keyword><keyword>*Clostridium difficile</keyword><keyword>Enterocolitis, Pseudomembranous/*therapy</keyword><keyword>Feces/*microbiology</keyword><keyword>Humans</keyword><keyword>Intestines/*microbiology</keyword><keyword>Metagenome</keyword><keyword>Recurrence</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2011</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>1537-6591 (Electronic)
1058-4838 (Linking)</isbn><accession-num>22002980</accession-num><urls><related-urls><url>;(60) (albeit perhaps slightly less in IBD ADDIN EN.CITE <EndNote><Cite><Author>Khoruts</Author><Year>2016</Year><RecNum>4782</RecNum><DisplayText>(61)</DisplayText><record><rec-number>4782</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803881">4782</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Khoruts, A.</author><author>Rank, K. M.</author><author>Newman, K. M.</author><author>Viskocil, K.</author><author>Vaughn, B. P.</author><author>Hamilton, M. J.</author><author>Sadowsky, M. J.</author></authors></contributors><auth-address>Division of Gastroenterology, Department of Medicine, University of Minnesota, Minneapolis, Minnesota; BioTechnology Institute, University of Minnesota, Minneapolis, Minnesota. Electronic address: khoru001@umn.edu.
Division of Gastroenterology, Department of Medicine, University of Minnesota, Minneapolis, Minnesota.
BioTechnology Institute, University of Minnesota, Minneapolis, Minnesota.</auth-address><titles><title>Inflammatory Bowel Disease Affects the Outcome of Fecal Microbiota Transplantation for Recurrent Clostridium difficile Infection</title><secondary-title>Clin Gastroenterol Hepatol</secondary-title></titles><periodical><full-title>Clin Gastroenterol Hepatol</full-title></periodical><pages>1433-8</pages><volume>14</volume><number>10</number><keywords><keyword>Clostridium Difficile</keyword><keyword>Complication</keyword><keyword>Crohn's Disease</keyword><keyword>Ulcerative Colitis</keyword></keywords><dates><year>2016</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>1542-7714 (Electronic)
1542-3565 (Linking)</isbn><accession-num>26905904</accession-num><urls><related-urls><url>;(61)) and could be considered in refractory C. difficile in UC. A systematic review of FMT including 22 IBD patients with C. difficile showed a response in 20/22 (91%) ADDIN EN.CITE <EndNote><Cite><Author>Sha</Author><Year>2014</Year><RecNum>3718</RecNum><DisplayText>(62)</DisplayText><record><rec-number>3718</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1403717609">3718</key><key app="ENWeb" db-id="">0</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sha, S.</author><author>Liang, J.</author><author>Chen, M.</author><author>Xu, B.</author><author>Liang, C.</author><author>Wei, N.</author><author>Wu, K.</author></authors></contributors><auth-address>State Key Laboratory of Cancer Biology & Xijing Hospital of Digestive Diseases, Fourth Military Medical University, Xi'an, Shaanxi Province, China.</auth-address><titles><title>Systematic review: faecal microbiota transplantation therapy for digestive and nondigestive disorders in adults and children</title><secondary-title>Aliment Pharmacol Ther</secondary-title><alt-title>Alimentary pharmacology & therapeutics</alt-title></titles><periodical><full-title>Aliment Pharmacol Ther</full-title></periodical><alt-periodical><full-title>Alimentary Pharmacology & Therapeutics</full-title></alt-periodical><pages>1003-32</pages><volume>39</volume><number>10</number><dates><year>2014</year><pub-dates><date>May</date></pub-dates></dates><isbn>1365-2036 (Electronic)
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ADDIN EN.CITE.DATA (68-71). A recent meta-analysis reported benefit of antiviral treatment in steroid refractory IBD patients (OR=0.20 (95%CI 0.08-0.49)). The risk of colectomy after receiving anti-viral therapy was lower in patients in whom CMV was diagnosed based on histology and/or immunohistochemistry (3 studies; OR=0.06 (95%CI 0.01–0.34) rather than tissue PCR ADDIN EN.CITE <EndNote><Cite><Author>Shukla</Author><Year>2015</Year><RecNum>4783</RecNum><DisplayText>(64)</DisplayText><record><rec-number>4783</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803881">4783</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Shukla, T.</author><author>Singh, S.</author><author>Loftus, E. V., Jr.</author><author>Bruining, D. H.</author><author>McCurdy, J. D.</author></authors></contributors><auth-address>Shukla,Tushar. *Division of Gastroenterology and Hepatology, The Ottawa Hospital, Ottawa, ON, Canada; and +Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, Minnesota.</auth-address><titles><title>Antiviral Therapy in Steroid-refractory Ulcerative Colitis with Cytomegalovirus: Systematic Review and Meta-analysis</title><secondary-title>Inflammatory Bowel Diseases</secondary-title></titles><periodical><full-title>Inflammatory Bowel Diseases</full-title></periodical><pages>2718-25</pages><volume>21</volume><number>11</number><dates><year>2015</year></dates><accession-num>26197450</accession-num><work-type>Meta-Analysis
Review</work-type><urls><related-urls><url> Technologies</remote-database-provider></record></Cite></EndNote>(64). One report described a child who underwent colectomy with subsequent identification of CMV, highlighting the importance of treating true infections in a timely manner ADDIN EN.CITE <EndNote><Cite><Author>Sebastian-Planas</Author><Year>1996</Year><RecNum>4788</RecNum><DisplayText>(72)</DisplayText><record><rec-number>4788</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803882">4788</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Sebastian-Planas, M.</author><author>Barrio-Merino, A.</author><author>Avilla-Hernandez, J.</author><author>Fortes-Alen, J. D.</author><author>Del Villar-Rubin, S.</author><author>Casas-Rivero, J.</author><author>Puyol-Buil, P.</author></authors></contributors><auth-address>Departments of Paediatrics and (*)Pathology, Hospital General de Mostoles, Madrid, Spain</auth-address><titles><title>Cytomegalovirus Infection of the Colon in Ulcerative Colitis: A Pediatric Case</title><secondary-title>Journal of Pediatric Gastroenterology & Nutrition</secondary-title></titles><periodical><full-title>Journal of Pediatric Gastroenterology & Nutrition</full-title></periodical><pages>186-190</pages><volume>23</volume><number>2</number><dates><year>1996</year></dates><urls><related-urls><url> Technologies</remote-database-provider></record></Cite></EndNote>(72). A case report of 6 children with CMV during an IBD flare suggested that ganciclovir treatment may be beneficial in some PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HaGlkaW5pPC9BdXRob3I+PFllYXI+MjAwNjwvWWVhcj48
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ADDIN EN.CITE.DATA (73). In a recent case-control study from the Porto group of ESPGHAN including children admitted with ASC (15 CMV positive and 41 CMV negative), steroid failure was higher in the 15 CM- positive (93%) than the 41 negative matched controls (56%; p=0.009) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db2hlbjwvQXV0aG9yPjxZZWFyPjIwMTc8L1llYXI+PFJl
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AG==
ADDIN EN.CITE.DATA (74). Of the CMV group, 93% were treated with ganciclovir (5/14 (36%) with 5mg/kg and 9/14 (64%) with 10mg/kg). Colectomy rates were higher in the CMV group on univariate analysis (33%) vs. the CMV negative controls (13%; p=0.049).Although enteric viruses have been associated with IBD flares PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LaGFuPC9BdXRob3I+PFllYXI+MjAwOTwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA (24, 75), limited data exist regarding their role in ASC. In one report, enteric viruses were identified in 1% of hospitalized children with IBD ADDIN EN.CITE <EndNote><Cite><Author>Vadlamudi</Author><Year>2013</Year><RecNum>4755</RecNum><DisplayText>(24)</DisplayText><record><rec-number>4755</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803873">4755</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Vadlamudi, N.B.</author><author>Hitch,M.C.</author><author>Thame,K.A.</author><author>Dimmitt,R.A.</author><author>Harrison,K.</author><author>Huisingh,C.</author><author>Maclin,J.S.</author></authors></contributors><titles><title>Enteric Infections In Hospitalized Pediatric Inflammatory Bowel Disease Patients With Relapse</title><secondary-title>The Internet Journal of Paediatrics and Neonatology</secondary-title></titles><periodical><full-title>The Internet Journal of Paediatrics and Neonatology</full-title></periodical><volume>16</volume><number>1</number><dates><year>2013</year></dates><urls></urls></record></Cite></EndNote>(24). In another small study of 9 IBD children, norovirus was suggested as a cause for disease exacerbations ADDIN EN.CITE <EndNote><Cite><Author>Khan</Author><Year>2009</Year><RecNum>4756</RecNum><DisplayText>(75)</DisplayText><record><rec-number>4756</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803873">4756</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Khan, R. R.</author><author>Lawson, A. D.</author><author>Minnich, L. L.</author><author>Martin, K.</author><author>Nasir, A.</author><author>Emmett, M. K.</author><author>Welch, C. A.</author><author>Udall, J. N., Jr.</author></authors></contributors><auth-address>Department of Pediatrics, West Virginia University Health Sciences Center, Charleston, WV, USA.</auth-address><titles><title>Gastrointestinal norovirus infection associated with exacerbation of inflammatory bowel disease</title><secondary-title>J Pediatr Gastroenterol Nutr</secondary-title></titles><periodical><full-title>J Pediatr Gastroenterol Nutr</full-title></periodical><pages>328-33</pages><volume>48</volume><number>3</number><keywords><keyword>Caliciviridae Infections/*complications</keyword><keyword>Case-Control Studies</keyword><keyword>Child</keyword><keyword>Colitis, Ulcerative/*complications</keyword><keyword>Crohn Disease/*complications</keyword><keyword>Diarrhea/etiology/*virology</keyword><keyword>Gastrointestinal Hemorrhage/etiology/*virology</keyword><keyword>Humans</keyword><keyword>*Norovirus</keyword><keyword>Retrospective Studies</keyword><keyword>Seasons</keyword></keywords><dates><year>2009</year><pub-dates><date>Mar</date></pub-dates></dates><isbn>1536-4801 (Electronic)
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ADDIN EN.CITE.DATA (77, 78). In a retrospective case control study, cryptosporidium was identified in 4.5% of all paediatric IBD relapses, including hospitalized UC. In that small report, treatment with nitazoxanide led to a better outcome PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WYWRsYW11ZGk8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFy
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WYWRsYW11ZGk8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFy
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ADDIN EN.CITE.DATA (79).Pain managementRecommendationNon-steroidal anti-inflammatory drugs (NSAID) should be avoided in ASC [EL5, adults EL3] (98% agreement)Opiates should be used exceptionally with caution and close monitoring, in doses equivalent to 0.1 mg/kg morphine, given the remote risk of facilitating megacolon [EL5, adults EL5] (98% agreement)Practice pointsBowel perforation or megacolon should be considered in case of severe or escalating abdominal pain (100% agreement).Hot packs and paracetamol could be attempted for pain management (95% agreement).Despite limited data, withdrawal of opiates has been suggested in adults given the potential of opiates and anticholinergics to trigger toxic megacolon, possibly due to decreased intestinal peristalsis PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EaWduYXNzPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48
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ADDIN EN.CITE.DATA (93-95). Several case reports describe ketamine use for pain management of IBD PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EdW5jYW48L0F1dGhvcj48WWVhcj4yMDAyPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (96, 97) including one in paediatric ASC suggesting that ketamine may be effective at reducing opiate and NSAID use ADDIN EN.CITE <EndNote><Cite><Author>White</Author><Year>2006</Year><RecNum>1302</RecNum><DisplayText>(97)</DisplayText><record><rec-number>1302</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">1302</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>White, M.</author><author>Shah, N.</author><author>Lindley, K.</author><author>Lloyd-Thomas, A.</author><author>Thomas, M.</author></authors></contributors><auth-address>United Bristol Health Care Trust, Bristol, UK. mcwdoc@.uk</auth-address><titles><title>Pain management in fulminating ulcerative colitis</title><secondary-title>Paediatr Anaesth</secondary-title></titles><periodical><full-title>Paediatr Anaesth</full-title></periodical><pages>1148-52</pages><volume>16</volume><number>11</number><keywords><keyword>Analgesia, Patient-Controlled</keyword><keyword>Analgesics/administration & dosage/ therapeutic use</keyword><keyword>Analgesics, Opioid/contraindications</keyword><keyword>Child</keyword><keyword>Colitis, Ulcerative/ complications</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Ketamine/administration & dosage/ therapeutic use</keyword><keyword>Male</keyword><keyword>Megacolon, Toxic/ complications</keyword><keyword>Morphine/contraindications</keyword><keyword>Pain/ drug therapy/etiology</keyword><keyword>Pain Measurement</keyword></keywords><dates><year>2006</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>1155-5645 (Print)</isbn><accession-num>17040304</accession-num><urls></urls></record></Cite></EndNote>(97). Cannabinoids modulate visceral sensation and pain in animal models PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5GaW9yYW1vbnRpPC9BdXRob3I+PFllYXI+MjAwODwvWWVh
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ADDIN EN.CITE.DATA (98-100), however there is no relevant evidence in ASC and it may be potentially hazardous given its inhibitory effect on bowel peristalsis. There is very limited or no evidence for use of clonidine or naloxone (with opioids) in ASC.Nutritional supportRecommendationsRegular diet should be continued in most ASC cases. Enteral (or parenteral in those not tolerating enteral) nutrition may be used if oral feeding is not tolerated or in malnutrition [EL4, adults EL1] (98% agreement)Oral or enteral feeding is contraindicated in cases of megacolon, or when surgery is imminent [EL5, adults EL5] (100% agreement)Practice pointsBody weight, caloric intake and hydration status should be monitored daily, including review by a dietician as needed (100% agreement).In non-septic patients, standard caloric, protein and micronutrient intake should be provided according to age. In malnourished patients or those at risk for malnutrition, additional calories may be needed, while monitoring closely for re-feeding syndrome (100% agreement). There are no data showing a benefit of specific diets in ASC and thus they should be avoided (98% agreement). Electrolyte imbalance (especially hypokalaemia and hypomagnesaemia) can promote colonic dilatation. Thus, electrolytes should be monitored, at least every 1-3 days, according to the degree of the baseline values and clinical status (98% agreement).RCTs in adults have shown no benefit of bowel rest in ASC PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5EaWNraW5zb248L0F1dGhvcj48WWVhcj4xOTgwPC9ZZWFy
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ADDIN EN.CITE.DATA (103). In a retrospective case series of 15 children with ASC who had bowel rest and TPN, 5 (33%) required colectomy which is identical to the colectomy rate reported otherwise ADDIN EN.CITE <EndNote><Cite><Author>Barabino</Author><Year>2002</Year><RecNum>124</RecNum><DisplayText>(13)</DisplayText><record><rec-number>124</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">124</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Barabino, A.</author><author>Tegaldo, L.</author><author>Castellano, E.</author><author>Gandullia, P.</author><author>Torrente, F.</author><author>Marino, C.</author><author>Mattioli, G.</author><author>Jasonni, V.</author></authors></contributors><auth-address>Paediatric Gastroenterology, Pathology Department, Istituto G. Gaslin, for Children, Genoa, Italy. abarab@tin.it</auth-address><titles><title>Severe attack of ulcerative colitis in children: retrospective clinical survey</title><secondary-title>Dig Liver Dis</secondary-title></titles><periodical><full-title>Dig Liver Dis</full-title></periodical><pages>44-9</pages><volume>34</volume><number>1</number><keywords><keyword>Adolescent</keyword><keyword>Child</keyword><keyword>Child, Preschool</keyword><keyword>Colitis, Ulcerative/classification/epidemiology/*therapy</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Outcome Assessment (Health Care)</keyword><keyword>Prevalence</keyword><keyword>Retrospective Studies</keyword><keyword>Severity of Illness Index</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2002</year><pub-dates><date>Jan</date></pub-dates></dates><accession-num>11926573</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>(13). In the prospective OSCI study of 128 children admitted for ASC PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UdXJuZXI8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (10), 74 (58%) were not on solid foods by the third admission day, but in a multivariate analysis this was not associated with improved outcome even after controlling for disease activity (personal communication from DT).ThromboprophylaxisRecommendationThe use of anticoagulation for preventing venous thromboembolic events (VTE) is recommended when one or more risk factors are present )according to age- see practice points) since the relative risk of VTE is higher during ASC, although the absolute rate is much lower than in adults [EL5, adults EL4] (98% agreement)Practice pointsSubcutaneous low molecular weight heparin (LMWH) should be considered in adolescents with ASC when one or more risk factors are present: smoking, oral contraceptives, complete immobilisation, central venous catheters (including PICC line), obesity, concurrent significant infection (e.g. respiratory, urinary, skin, and intra-abdominal), known prothrombotic disorder, previous VTE, and family history of VTE. Treatment duration should be individualized in consultation with the haematologists (91% agreement).In prepubertal children, further evaluation of the safety and efficacy of thromboprophylaxis is required prior to widespread use. Thus, thromboprophylaxis may be considered in those with at least two risk factors (95% agreement). The most common LMWH is subcutaneous enoxaparin 1mg/kg/day (100IU/kg/day) in one daily dose. Monitoring with anti-Xa activity level is not usually required, except in children with significant renal impairment (100% agreement). Mobilization, adequate hydration, and prompt removal of un-needed central venous and arterial catheters, should be encouraged (100% agreement).Adult guidelines PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ccm93bjwvQXV0aG9yPjxZZWFyPjIwMDg8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (104-106) recommend that LMWH should be commenced in ASC to prevent VTE which are much more common than in quiescent IBD ADDIN EN.CITE <EndNote><Cite><Author>Nguyen</Author><Year>2008</Year><RecNum>2463</RecNum><DisplayText>(107)</DisplayText><record><rec-number>2463</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">2463</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Nguyen, G. C.</author><author>Sam, J.</author></authors></contributors><auth-address>Mount Sinai Hospital IBD Centre, University of Toronto School of Medicine, Toronto, Ontario, Canada.</auth-address><titles><title>Rising prevalence of venous thromboembolism and its impact on mortality among hospitalized inflammatory bowel disease patients</title><secondary-title>Am J Gastroenterol</secondary-title></titles><periodical><full-title>Am J Gastroenterol</full-title></periodical><pages>2272-80</pages><volume>103</volume><number>9</number><keywords><keyword>Adult</keyword><keyword>Chi-Square Distribution</keyword><keyword>Female</keyword><keyword>*Hospitalization</keyword><keyword>Humans</keyword><keyword>Incidence</keyword><keyword>Inflammatory Bowel Diseases/*mortality</keyword><keyword>Length of Stay/statistics & numerical data</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Prevalence</keyword><keyword>Regression Analysis</keyword><keyword>United States/epidemiology</keyword><keyword>Venous Thromboembolism/*epidemiology</keyword></keywords><dates><year>2008</year><pub-dates><date>Sep</date></pub-dates></dates><accession-num>18684186</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>(107) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Ob3ZhY2VrPC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48
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ADDIN EN.CITE.DATA (108) ADDIN EN.CITE <EndNote><Cite><Author>Danese</Author><Year>2007</Year><RecNum>1805</RecNum><DisplayText>(109)</DisplayText><record><rec-number>1805</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">1805</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Danese, S.</author><author>Papa, A.</author><author>Saibeni, S.</author><author>Repici, A.</author><author>Malesci, A.</author><author>Vecchi, M.</author></authors></contributors><auth-address>Division of Gastroenterology, IRCCS Istituto Clinico Humanitas, Rozzano, Milan, Italy</auth-address><titles><title>Inflammation and coagulation in inflammatory bowel disease: The clot thickens</title><secondary-title>American Journal of Gastroenterology</secondary-title></titles><periodical><full-title>American Journal of Gastroenterology</full-title></periodical><pages>174-186</pages><volume>102</volume><number>1</number><reprint-edition>NOT IN FILE</reprint-edition><keywords><keyword>abnormalities</keyword><keyword>Blood Coagulation</keyword><keyword>Blood Coagulation Disorders</keyword><keyword>Cells</keyword><keyword>Colitis</keyword><keyword>complications</keyword><keyword>Disease</keyword><keyword>Disease Progression</keyword><keyword>epidemiology</keyword><keyword>etiology</keyword><keyword>Fibrinolysis</keyword><keyword>Gastroenterology</keyword><keyword>genetics</keyword><keyword>Humans</keyword><keyword>Inflammation</keyword><keyword>Inflammation Mediators</keyword><keyword>Inflammatory Bowel Diseases</keyword><keyword>Italy</keyword><keyword>Paper</keyword><keyword>physiology</keyword><keyword>physiopathology</keyword><keyword>Research</keyword><keyword>Risk</keyword><keyword>Risk Factors</keyword><keyword>Role</keyword><keyword>Thrombosis</keyword><keyword>ULCERATIVE COLITIS</keyword></keywords><dates><year>2007</year></dates><work-type>AJG943 pii ;10.1111/j.1572-0241.2006.00943.x doi</work-type><urls><related-urls><url>PM:17100967</url></related-urls></urls></record></Cite></EndNote>(109) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5HcmFpbmdlPC9BdXRob3I+PFllYXI+MjAxMDwvWWVhcj48
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ADDIN EN.CITE.DATA (117-119). While the absolute risk of VTE is much lower in children as compared with adults (9 events per 10,000 patient/years in children vs. 24 in those 40-60 years of age), the odds-ratio compared with controls is higher (OR~5 in children vs. ~2 in the 40-60 years old), given the very low background risk PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LYXBwZWxtYW48L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFy
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ADDIN EN.CITE.DATA (112). The risk for VTE occurs mostly during active disease, and more frequently in UC compared to Crohn’s disease ADDIN EN.CITE <EndNote><Cite><Author>Lazzerini</Author><Year>2011</Year><RecNum>4804</RecNum><DisplayText>(120)</DisplayText><record><rec-number>4804</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803886">4804</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lazzerini, M.</author><author>Bramuzzo, M.</author><author>Maschio, M.</author><author>Martelossi, S.</author><author>Ventura, A.</author></authors></contributors><auth-address>Unit of Research on Health Services and International Health, Institute for Child Health IRCCS Burlo Garofolo, Trieste, Italy. lazzerini@burlo.trieste.it</auth-address><titles><title>Thromboembolism in pediatric inflammatory bowel disease: systematic review</title><secondary-title>Inflamm Bowel Dis</secondary-title></titles><periodical><full-title>Inflamm Bowel Dis</full-title></periodical><pages>2174-83</pages><volume>17</volume><number>10</number><edition>2011/09/13</edition><keywords><keyword>Adult</keyword><keyword>Child</keyword><keyword>Humans</keyword><keyword>Inflammatory Bowel Diseases/ complications</keyword><keyword>Risk Factors</keyword><keyword>Thromboembolism/ etiology</keyword></keywords><dates><year>2011</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>1536-4844 (Electronic)
1078-0998 (Linking)</isbn><accession-num>21910180</accession-num><urls></urls><electronic-resource-num>10.1002/ibd.21563</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(120). In a systematic review of paediatric studies, 50% of IBD children who developed VTE had at least one risk factor; 24% of whom had at least two ADDIN EN.CITE <EndNote><Cite><Author>Lazzerini</Author><Year>2011</Year><RecNum>4804</RecNum><DisplayText>(120)</DisplayText><record><rec-number>4804</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803886">4804</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lazzerini, M.</author><author>Bramuzzo, M.</author><author>Maschio, M.</author><author>Martelossi, S.</author><author>Ventura, A.</author></authors></contributors><auth-address>Unit of Research on Health Services and International Health, Institute for Child Health IRCCS Burlo Garofolo, Trieste, Italy. lazzerini@burlo.trieste.it</auth-address><titles><title>Thromboembolism in pediatric inflammatory bowel disease: systematic review</title><secondary-title>Inflamm Bowel Dis</secondary-title></titles><periodical><full-title>Inflamm Bowel Dis</full-title></periodical><pages>2174-83</pages><volume>17</volume><number>10</number><edition>2011/09/13</edition><keywords><keyword>Adult</keyword><keyword>Child</keyword><keyword>Humans</keyword><keyword>Inflammatory Bowel Diseases/ complications</keyword><keyword>Risk Factors</keyword><keyword>Thromboembolism/ etiology</keyword></keywords><dates><year>2011</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>1536-4844 (Electronic)
1078-0998 (Linking)</isbn><accession-num>21910180</accession-num><urls></urls><electronic-resource-num>10.1002/ibd.21563</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(120). The site of VTE was cerebral in 54%, limbs in 26%, and abdominal vessels in 26%. Taken together, it could be concluded that while ASC increases the risk for VTE also in children, the absolute risk is lower than in adults, especially in the youngest age groups. Therefore, the presence of risk factors may identify those who are at particular risk ADDIN EN.CITE <EndNote><Cite><Author>Lazzerini</Author><Year>2011</Year><RecNum>4804</RecNum><DisplayText>(120)</DisplayText><record><rec-number>4804</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803886">4804</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Lazzerini, M.</author><author>Bramuzzo, M.</author><author>Maschio, M.</author><author>Martelossi, S.</author><author>Ventura, A.</author></authors></contributors><auth-address>Unit of Research on Health Services and International Health, Institute for Child Health IRCCS Burlo Garofolo, Trieste, Italy. lazzerini@burlo.trieste.it</auth-address><titles><title>Thromboembolism in pediatric inflammatory bowel disease: systematic review</title><secondary-title>Inflamm Bowel Dis</secondary-title></titles><periodical><full-title>Inflamm Bowel Dis</full-title></periodical><pages>2174-83</pages><volume>17</volume><number>10</number><edition>2011/09/13</edition><keywords><keyword>Adult</keyword><keyword>Child</keyword><keyword>Humans</keyword><keyword>Inflammatory Bowel Diseases/ complications</keyword><keyword>Risk Factors</keyword><keyword>Thromboembolism/ etiology</keyword></keywords><dates><year>2011</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>1536-4844 (Electronic)
1078-0998 (Linking)</isbn><accession-num>21910180</accession-num><urls></urls><electronic-resource-num>10.1002/ibd.21563</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(120). Enoxaparin is the most frequently used drug for prophylaxis of VTE in children and adolescents ADDIN EN.CITE <EndNote><Cite><Author>Molinari</Author><Year>2015</Year><RecNum>4805</RecNum><DisplayText>(121)</DisplayText><record><rec-number>4805</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803887">4805</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Molinari, A. C.</author><author>Banov, L.</author><author>Bertamino, M.</author><author>Barabino, P.</author><author>Lassandro, G.</author><author>Giordano, P.</author></authors></contributors><auth-address>1Thrombosis and Hemostasis Unit, Giannina Gaslini Children's Hospital , Genova , Italy.</auth-address><titles><title>A practical approach to the use of low molecular weight heparins in VTE treatment and prophylaxis in children and newborns</title><secondary-title>Pediatr Hematol Oncol</secondary-title></titles><periodical><full-title>Pediatr Hematol Oncol</full-title></periodical><pages>1-10</pages><volume>32</volume><number>1</number><edition>2014/10/18</edition><keywords><keyword>Adolescent</keyword><keyword>Anticoagulants/adverse effects/ therapeutic use</keyword><keyword>Child</keyword><keyword>Child, Preschool</keyword><keyword>Female</keyword><keyword>Heparin, Low-Molecular-Weight/adverse effects/ therapeutic use</keyword><keyword>Humans</keyword><keyword>Infant</keyword><keyword>Infant, Newborn</keyword><keyword>Male</keyword><keyword>Venous Thromboembolism/blood/ drug therapy</keyword><keyword>enoxaparin</keyword><keyword>low-molecular weight heparin</keyword><keyword>neonate</keyword><keyword>prophylaxis</keyword><keyword>treatment</keyword></keywords><dates><year>2015</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>1521-0669 (Electronic)
0888-0018 (Linking)</isbn><accession-num>25325764</accession-num><urls></urls><electronic-resource-num>10.3109/08880018.2014.960119</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(121) ADDIN EN.CITE <EndNote><Cite><Author>Ko</Author><Year>2012</Year><RecNum>4806</RecNum><DisplayText>(122)</DisplayText><record><rec-number>4806</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803887">4806</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ko, R. H.</author><author>Young, G.</author></authors></contributors><auth-address>Children's Center for Cancer and Blood Diseases, Children's Hospital Los Angeles, Los Angeles, CA 90027, USA.</auth-address><titles><title>Pharmacokinetic- and pharmacodynamic-based antithrombotic dosing recommendations in children</title><secondary-title>Expert Rev Clin Pharmacol</secondary-title></titles><periodical><full-title>Expert Rev Clin Pharmacol</full-title></periodical><pages>389-96</pages><volume>5</volume><number>4</number><edition>2012/09/05</edition><keywords><keyword>Adult</keyword><keyword>Age Factors</keyword><keyword>Anticoagulants/ administration & dosage/pharmacokinetics/pharmacology</keyword><keyword>Body Surface Area</keyword><keyword>Body Weight</keyword><keyword>Child</keyword><keyword>Dose-Response Relationship, Drug</keyword><keyword>Drug Dosage Calculations</keyword><keyword>Fibrinolytic Agents/ administration & dosage/pharmacokinetics/pharmacology</keyword><keyword>Hemostasis/physiology</keyword><keyword>Humans</keyword><keyword>Infant</keyword><keyword>Infant, Newborn</keyword><keyword>Practice Guidelines as Topic</keyword><keyword>Venous Thromboembolism/ prevention & control</keyword></keywords><dates><year>2012</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1751-2441 (Electronic)
1751-2433 (Linking)</isbn><accession-num>22943118</accession-num><urls></urls><electronic-resource-num>10.1586/ecp.12.23</electronic-resource-num><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(122) ADDIN EN.CITE <EndNote><Cite><Author>Albisetti</Author><Year>2002</Year><RecNum>4807</RecNum><DisplayText>(123)</DisplayText><record><rec-number>4807</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803887">4807</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Albisetti, M.</author><author>Andrew, M.</author></authors></contributors><auth-address>Division of Haematology/Oncology, The Hospital for Sick Children, Toronto, Ontario, Canada. manuela.albisetti@kispi.unizh.ch</auth-address><titles><title>Low molecular weight heparin in children</title><secondary-title>Eur J Pediatr</secondary-title></titles><periodical><full-title>Eur J Pediatr</full-title></periodical><pages>71-7</pages><volume>161</volume><number>2</number><edition>2002/04/17</edition><keywords><keyword>Age Factors</keyword><keyword>Child</keyword><keyword>Child, Preschool</keyword><keyword>Dose-Response Relationship, Drug</keyword><keyword>Drug Administration Schedule</keyword><keyword>Female</keyword><keyword>Heparin, Low-Molecular-Weight/adverse effects/ therapeutic use</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Sensitivity and Specificity</keyword><keyword>Thromboembolism/diagnosis/ drug therapy</keyword><keyword>Thrombolytic Therapy/ methods</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2002</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>0340-6199 (Print)
0340-6199 (Linking)</isbn><accession-num>11954754</accession-num><urls></urls><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(123). LMWH at prophylactic doses is effective, well tolerated and safe in children and adolescents while significant bleeding complications are very rare PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UcmFtZTwvQXV0aG9yPjxZZWFyPjIwMTA8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (124, 125). Minor bleeding episodes during prophylactic use of enoxaparin were reported at ~5-6% ADDIN EN.CITE <EndNote><Cite><Author>Dix</Author><Year>2000</Year><RecNum>4810</RecNum><DisplayText>(126)</DisplayText><record><rec-number>4810</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803888">4810</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Dix, D.</author><author>Andrew, M.</author><author>Marzinotto, V.</author><author>Charpentier, K.</author><author>Bridge, S.</author><author>Monagle, P.</author><author>deVeber, G.</author><author>Leaker, M.</author><author>Chan, A. K.</author><author>Massicotte, M. P.</author></authors></contributors><auth-address>Division of Hematology/Oncology, Hospital for Sick Children, Toronto, Ontario, Canada.</auth-address><titles><title>The use of low molecular weight heparin in pediatric patients: a prospective cohort study</title><secondary-title>J Pediatr</secondary-title></titles><periodical><full-title>J Pediatr</full-title></periodical><pages>439-45</pages><volume>136</volume><number>4</number><edition>2001/02/07</edition><keywords><keyword>Adolescent</keyword><keyword>Anticoagulants/ administration & dosage/adverse effects</keyword><keyword>Child</keyword><keyword>Child, Preschool</keyword><keyword>Cohort Studies</keyword><keyword>Enoxaparin/ administration & dosage/adverse effects</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Infant</keyword><keyword>Infant, Newborn</keyword><keyword>Male</keyword><keyword>Prospective Studies</keyword><keyword>Single-Blind Method</keyword><keyword>Thromboembolism/drug therapy/mortality/prevention & control</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2000</year><pub-dates><date>Apr</date></pub-dates></dates><isbn>0022-3476 (Print)
0022-3476 (Linking)</isbn><accession-num>10753240</accession-num><urls></urls><remote-database-provider>NLM</remote-database-provider><language>eng</language></record></Cite></EndNote>(126) ADDIN EN.CITE <EndNote><Cite><Author>Schobess</Author><Year>2006</Year><RecNum>4811</RecNum><DisplayText>(127)</DisplayText><record><rec-number>4811</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803888">4811</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Schobess, R.</author><author>During, C.</author><author>Bidlingmaier, C.</author><author>Heinecke, A.</author><author>Merkel, N.</author><author>Nowak-Gottl, U.</author></authors></contributors><auth-address>Department of Paediatrics, Univ. Children's Hospital Halle, Germany.</auth-address><titles><title>Long-term safety and efficacy data on childhood venous thrombosis treated with a low molecular weight heparin: an open-label pilot study of once-daily versus twice-daily enoxaparin administration</title><secondary-title>Haematologica</secondary-title></titles><periodical><full-title>Haematologica</full-title></periodical><pages>1701-4</pages><volume>91</volume><number>12</number><edition>2006/12/06</edition><keywords><keyword>Adolescent</keyword><keyword>Child</keyword><keyword>Child, Preschool</keyword><keyword>Drug Administration Schedule</keyword><keyword>Enoxaparin/ administration & dosage/ adverse effects</keyword><keyword>Female</keyword><keyword>Follow-Up Studies</keyword><keyword>Hemorrhage/chemically induced/epidemiology</keyword><keyword>Heparin, Low-Molecular-Weight/ administration & dosage/ adverse effects</keyword><keyword>Humans</keyword><keyword>Infant</keyword><keyword>Male</keyword><keyword>Pilot Projects</keyword><keyword>Prospective Studies</keyword><keyword>Time</keyword><keyword>Venous Thrombosis/ drug therapy/epidemiology</keyword></keywords><dates><year>2006</year><pub-dates><date>Dec</date></pub-dates></dates><isbn>1592-8721 (Electronic)
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ADDIN EN.CITE.DATA (128, 129), reported in 2-10% of patients ADDIN EN.CITE <EndNote><Cite><Author>Loftus</Author><Year>2004</Year><RecNum>1989</RecNum><DisplayText>(130)</DisplayText><record><rec-number>1989</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">1989</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Loftus, E. V., Jr.</author><author>Kane, S. V.</author><author>Bjorkman, D.</author></authors></contributors><auth-address>Division of Gastroenterology and Hepatology, Mayo Clinic, Rochester, MN 55905, USA. loftus.edward@mayo.edu</auth-address><titles><title>Systematic review: short-term adverse effects of 5-aminosalicylic acid agents in the treatment of ulcerative colitis</title><secondary-title>Alimentary Pharmacology and Therapeutics</secondary-title></titles><periodical><full-title>Alimentary Pharmacology and Therapeutics</full-title></periodical><pages>179-189</pages><volume>19</volume><number>2</number><reprint-edition>NOT IN FILE</reprint-edition><keywords><keyword>5-AMINOSALICYLIC ACID</keyword><keyword>administration & dosage</keyword><keyword>Administration,Oral</keyword><keyword>adverse effects</keyword><keyword>Aminosalicylic Acids</keyword><keyword>Anti-Inflammatory Agents</keyword><keyword>Anti-Inflammatory Agents,Non-Steroidal</keyword><keyword>Anti-Ulcer Agents</keyword><keyword>Colitis</keyword><keyword>Colitis,Ulcerative</keyword><keyword>Double-Blind Method</keyword><keyword>drug therapy</keyword><keyword>Humans</keyword><keyword>Mesalamine</keyword><keyword>methods</keyword><keyword>Phenylhydrazines</keyword><keyword>Randomized Controlled Trials as Topic</keyword><keyword>Safety</keyword><keyword>Sulfasalazine</keyword><keyword>ULCERATIVE COLITIS</keyword></keywords><dates><year>2004</year></dates><isbn>0269-2813 (Print)</isbn><urls><related-urls><url>PM:14723609</url></related-urls></urls></record></Cite></EndNote>(130).AntibioticsRecommendationAntibiotics are not routinely recommended in children with ASC at admission. However, empiric antibiotic treatment may be considered when C. difficile or other bacterial infection is suspected until stool analysis is available [EL5, adults EL5] (100% agreement)Two meta-analyses of antibiotic therapy in adult patients with ASC found nine RCTs, involving more than 600 patients, showing a statistically significant benefit for antibiotics in inducing remission PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5LaGFuPC9BdXRob3I+PFllYXI+MjAxMTwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA (131, 132). Interestingly, all trials on intravenous antibiotics ADDIN EN.CITE <EndNote><Cite><Author>Chapman</Author><Year>1986</Year><RecNum>1572</RecNum><DisplayText>(133)</DisplayText><record><rec-number>1572</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">1572</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Chapman, R. W.</author><author>Selby, W. S.</author><author>Jewell, D. P.</author></authors></contributors><titles><title>Controlled trial of intravenous metronidazole as an adjunct to corticosteroids in severe ulcerative colitis</title><secondary-title>Gut</secondary-title></titles><periodical><full-title>Gut</full-title></periodical><pages>1210-2</pages><volume>27</volume><number>10</number><edition>1986/10/01</edition><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Clinical Trials as Topic</keyword><keyword>Colitis, Ulcerative/*drug therapy</keyword><keyword>Double-Blind Method</keyword><keyword>Drug Therapy, Combination</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Hydrocortisone/*therapeutic use</keyword><keyword>Injections, Intravenous</keyword><keyword>Male</keyword><keyword>Methylprednisolone/*therapeutic use</keyword><keyword>Metronidazole/administration & dosage/*therapeutic use</keyword><keyword>Middle Aged</keyword></keywords><dates><year>1986</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>0017-5749 (Print)
0017-5749 (Linking)</isbn><accession-num>3536677</accession-num><urls><related-urls><url>;(133) ADDIN EN.CITE <EndNote><Cite><Author>Mantzaris</Author><Year>2001</Year><RecNum>172</RecNum><DisplayText>(134)</DisplayText><record><rec-number>172</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">172</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mantzaris, G. J.</author><author>Petraki, K.</author><author>Archavlis, E.</author><author>Amberiadis, P.</author><author>Kourtessas, D.</author><author>Christidou, A.</author><author>Triantafyllou, G.</author></authors></contributors><auth-address>A' Gastroenterology Clinic, Evangelismos Hospital, Athens, Greece. Shad@aua.gr</auth-address><titles><title>A prospective randomized controlled trial of intravenous ciprofloxacin as an adjunct to corticosteroids in acute, severe ulcerative colitis</title><secondary-title>Scand J Gastroenterol</secondary-title></titles><periodical><full-title>Scand J Gastroenterol</full-title></periodical><pages>971-4</pages><volume>36</volume><number>9</number><keywords><keyword>Acute Disease</keyword><keyword>Adult</keyword><keyword>Anti-Infective Agents/administration & dosage/*therapeutic use</keyword><keyword>Anti-Inflammatory Agents/administration & dosage/*therapeutic use</keyword><keyword>Ciprofloxacin/administration & dosage/*therapeutic use</keyword><keyword>Colitis, Ulcerative/*drug therapy</keyword><keyword>Double-Blind Method</keyword><keyword>Drug Therapy, Combination</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Hydrocortisone/administration & dosage/*therapeutic use</keyword><keyword>Male</keyword><keyword>Parenteral Nutrition</keyword><keyword>Prospective Studies</keyword></keywords><dates><year>2001</year><pub-dates><date>Sep</date></pub-dates></dates><accession-num>11521989</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>(134) ADDIN EN.CITE <EndNote><Cite><Author>Mantzaris</Author><Year>1994</Year><RecNum>168</RecNum><DisplayText>(135)</DisplayText><record><rec-number>168</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">168</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mantzaris, G. J.</author><author>Hatzis, A.</author><author>Kontogiannis, P.</author><author>Triadaphyllou, G.</author></authors></contributors><auth-address>First Department of Gastroenterology, Evangelismos Hospital, Athens, Greece.</auth-address><titles><title>Intravenous tobramycin and metronidazole as an adjunct to corticosteroids in acute, severe ulcerative colitis</title><secondary-title>Am J Gastroenterol</secondary-title></titles><periodical><full-title>Am J Gastroenterol</full-title></periodical><pages>43-6</pages><volume>89</volume><number>1</number><keywords><keyword>Acute Disease</keyword><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Chemotherapy, Adjuvant</keyword><keyword>Colitis, Ulcerative/*drug therapy</keyword><keyword>Drug Therapy, Combination</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Hydrocortisone/*administration & dosage</keyword><keyword>Injections, Intravenous</keyword><keyword>Male</keyword><keyword>Metronidazole/*administration & dosage</keyword><keyword>Middle Aged</keyword><keyword>Prospective Studies</keyword><keyword>Tobramycin/*administration & dosage</keyword></keywords><dates><year>1994</year><pub-dates><date>Jan</date></pub-dates></dates><accession-num>8273796</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>(135) showed no beneficial effects, whereas most of the trials on oral antibiotics PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5PaGt1c2E8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (138) ADDIN EN.CITE <EndNote><Cite><Author>Dickinson</Author><Year>1985</Year><RecNum>1911</RecNum><DisplayText>(139)</DisplayText><record><rec-number>1911</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">1911</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Dickinson, R. J.</author><author>O'Connor, H. J.</author><author>Pinder, I.</author><author>Hamilton, I.</author><author>Johnston, D.</author><author>Axon, A. T.</author></authors></contributors><titles><title>Double blind controlled trial of oral vancomycin as adjunctive treatment in acute exacerbations of idiopathic colitis</title><secondary-title>Gut</secondary-title></titles><periodical><full-title>Gut</full-title></periodical><pages>1380-1384</pages><volume>26</volume><number>12</number><reprint-edition>NOT IN FILE</reprint-edition><keywords><keyword>Adult</keyword><keyword>Clinical Trials as Topic</keyword><keyword>Colitis</keyword><keyword>Colitis,Ulcerative</keyword><keyword>Crohn Disease</keyword><keyword>Double-Blind Method</keyword><keyword>drug therapy</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>surgery</keyword><keyword>therapeutic use</keyword><keyword>therapy</keyword><keyword>Vancomycin</keyword></keywords><dates><year>1985</year></dates><isbn>0017-5749 (Print)</isbn><urls><related-urls><url>PM:3910524</url></related-urls></urls></record></Cite></EndNote>(139) ADDIN EN.CITE <EndNote><Cite><Author>Burke</Author><Year>1990</Year><RecNum>1912</RecNum><DisplayText>(140)</DisplayText><record><rec-number>1912</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">1912</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Burke, D. A.</author><author>Axon, A. T.</author><author>Clayden, S. A.</author><author>Dixon, M. F.</author><author>Johnston, D.</author><author>Lacey, R. W.</author></authors></contributors><auth-address>Gastroenterology Unit, General Infirmary, Leeds, UK</auth-address><titles><title>The efficacy of tobramycin in the treatment of ulcerative colitis</title><secondary-title>Alimentary Pharmacology and Therapeutics</secondary-title></titles><periodical><full-title>Alimentary Pharmacology and Therapeutics</full-title></periodical><pages>123-129</pages><volume>4</volume><number>2</number><reprint-edition>NOT IN FILE</reprint-edition><keywords><keyword>Adult</keyword><keyword>Colitis</keyword><keyword>Colitis,Ulcerative</keyword><keyword>Double-Blind Method</keyword><keyword>drug therapy</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>pharmacokinetics</keyword><keyword>physiopathology</keyword><keyword>therapeutic use</keyword><keyword>therapy</keyword><keyword>Tobramycin</keyword></keywords><dates><year>1990</year></dates><isbn>0269-2813 (Print)</isbn><urls><related-urls><url>PM:2104079</url></related-urls></urls></record></Cite></EndNote>(140) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UdXJ1bmVuPC9BdXRob3I+PFllYXI+MTk5ODwvWWVhcj48
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ADDIN EN.CITE.DATA (141) ADDIN EN.CITE <EndNote><Cite><Author>Gionchetti</Author><Year>1999</Year><RecNum>3310</RecNum><DisplayText>(142)</DisplayText><record><rec-number>3310</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">3310</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Gionchetti, P.</author><author>Rizzello, F.</author><author>Ferrieri, A.</author><author>Venturi, A.</author><author>Brignola, C.</author><author>Ferretti, M.</author><author>Peruzzo, S.</author><author>Miglioli, M.</author><author>Campieri, M.</author></authors></contributors><titles><title>Rifaximin in patients with moderate or severe ulcerative colitis refractory to steroid-treatment: a double-blind, placebo-controlled trial</title><secondary-title>Dig Dis Sci</secondary-title></titles><periodical><full-title>Dig Dis Sci</full-title></periodical><pages>1220-1</pages><volume>44</volume><number>6</number><edition>1999/07/02</edition><keywords><keyword>Colitis, Ulcerative/*drug therapy/metabolism</keyword><keyword>Double-Blind Method</keyword><keyword>Gastrointestinal Agents/pharmacokinetics/*therapeutic use</keyword><keyword>Humans</keyword><keyword>Pilot Projects</keyword><keyword>Placebos</keyword><keyword>Rifamycins/pharmacokinetics/*therapeutic use</keyword></keywords><dates><year>1999</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>0163-2116 (Print)
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ADDIN EN.CITE.DATA (143) showed some beneficial effects, as observed by Turner and colleagues ADDIN EN.CITE <EndNote><Cite><Author>Turner</Author><Year>2014</Year><RecNum>4374</RecNum><DisplayText>(144)</DisplayText><record><rec-number>4374</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1405065575">4374</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Turner, D.</author><author>Levine, A.</author><author>Kolho, K. L.</author><author>Shaoul, R.</author><author>Ledder, O.</author></authors></contributors><auth-address>The Juliet Keidan Institute of Pediatric Gastroenterology and Nutrition Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel. Electronic address: turnerd@.il.
Wolfson Medical Center, Holon, Israel.
Pediatric Gastroenterology, Hospital for Children and Adolescents, Helsinki University Central Hospital, Helsinki, Finland.
Pediatric Gastroenterology Unit, Rambam Medical Center, Haifa, Israel.
The Juliet Keidan Institute of Pediatric Gastroenterology and Nutrition Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.</auth-address><titles><title>Combination of oral antibiotics may be effective in severe pediatric ulcerative colitis: A preliminary report</title><secondary-title>J Crohns Colitis</secondary-title><alt-title>Journal of Crohn's & colitis</alt-title></titles><periodical><full-title>J Crohns Colitis</full-title></periodical><alt-periodical><full-title>Journal of Crohn's & Colitis</full-title></alt-periodical><pages>1464-70</pages><volume>8</volume><number>11</number><dates><year>2014</year><pub-dates><date>Jun 20</date></pub-dates></dates><isbn>1876-4479 (Electronic)
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ADDIN EN.CITE.DATA (105, 106, 145) recommend the use of antibiotics only if infection is considered, or immediately prior to surgery. A small retrospective multicentre study ADDIN EN.CITE <EndNote><Cite><Author>Turner</Author><Year>2014</Year><RecNum>4374</RecNum><DisplayText>(144)</DisplayText><record><rec-number>4374</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1405065575">4374</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Turner, D.</author><author>Levine, A.</author><author>Kolho, K. L.</author><author>Shaoul, R.</author><author>Ledder, O.</author></authors></contributors><auth-address>The Juliet Keidan Institute of Pediatric Gastroenterology and Nutrition Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel. Electronic address: turnerd@.il.
Wolfson Medical Center, Holon, Israel.
Pediatric Gastroenterology, Hospital for Children and Adolescents, Helsinki University Central Hospital, Helsinki, Finland.
Pediatric Gastroenterology Unit, Rambam Medical Center, Haifa, Israel.
The Juliet Keidan Institute of Pediatric Gastroenterology and Nutrition Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Israel.</auth-address><titles><title>Combination of oral antibiotics may be effective in severe pediatric ulcerative colitis: A preliminary report</title><secondary-title>J Crohns Colitis</secondary-title><alt-title>Journal of Crohn's & colitis</alt-title></titles><periodical><full-title>J Crohns Colitis</full-title></periodical><alt-periodical><full-title>Journal of Crohn's & Colitis</full-title></alt-periodical><pages>1464-70</pages><volume>8</volume><number>11</number><dates><year>2014</year><pub-dates><date>Jun 20</date></pub-dates></dates><isbn>1876-4479 (Electronic)
1873-9946 (Linking)</isbn><accession-num>24958064</accession-num><urls><related-urls><url>;(144) stated that the use of an oral wide-spectrum antibiotic cocktail (including metronidazole, amoxicillin, doxycycline and – in hospitalized patients – also vancomycin) in children with moderate to severe UC, refractory to multiple immunosuppressants, was effective in 47% of patients. This cocktail has been further explored in a pilot RCT, the PRASCO trial, in which the oral antibiotic cocktail was prescribed as an add-on therapy to IVCS in 28 children admitted with ASC ADDIN EN.CITE <EndNote><Cite><Author>Turner</Author><Year>2018</Year><RecNum>278</RecNum><DisplayText>(146)</DisplayText><record><rec-number>278</rec-number><foreign-keys><key app="EN" db-id="asfftxp5b0w0pwexrs5xt9djs5vf95ateaxt" timestamp="1515050432">278</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Turner, D</author><author>Vlamakis, H</author><author>Marcus, D</author><author>Yassour, M</author><author>Bishai, J</author><author>Yerushalmi, B</author><author>Aloi, M</author><author>Griffiths, A</author><author>Albenberg, L</author><author>Kolho, KL</author><author>Cohen, S</author><author>Abitbol, G</author><author>Xavier, R</author><author>Levine, A</author></authors></contributors><titles><title>Manipulating the microbiome in pediatric Acute Severe Colitis with antibiotics cocktail: a pilot randomized controlled trial</title><secondary-title>ESPGHAN 51st Annual meeting 9-12 May, 2018</secondary-title></titles><periodical><full-title>ESPGHAN 51st Annual meeting 9-12 May, 2018</full-title></periodical><dates><year>2018</year></dates><work-type>Abstract</work-type><urls></urls></record></Cite></EndNote>(146). Day 5 PUCAI was significantly lower in the antibiotics+IVCS arm vs IVCS alone (25±16.7 vs 40.4±20.4, p=0.037), meeting the primary outcome of that trial. However the trial was not powered to detect differences in need for 2nd line therapy because there were only 2-3 IVCS failures in each group. Some of the authors of these guidelines have used the cocktail in treating steroid-refractory children with ASC as a last resort, at times awaiting colectomy, and a response has been clearly documented in some. Taken together, a short course of the oral antibiotic cocktail could be considered in selected severe refractory cases, while preparing for colectomy. Antibiotics should be discontinued if no significant response has been observed in 4-7 days. In any case, salvage therapy should not be delayed for the sake of this attempt.CorticosteroidsRecommendationIntravenous methylprednisolone 1 mg/kg/day (up to 40 mg/day) once daily in the morning is recommended as the initial treatment at admission [EL2, adults EL1]; a higher dose of 1.5 mg/kg/day (up to 60 mg/day) in one or two divided daily doses should be reserved to the more severe end of the spectrum and for children who have failed oral steroids prior to admission [EL4, adults EL4] (100% agreement) Practice points:As there is no firm evidence that the higher dose is superior to the lower dose, a rapid decline of methylprednisolone to 1mg/kg/d (40 mg/d) should be employed once response has been observed (98% agreement).Methylprednisolone has less mineralocorticoid effect and thus is preferred over hydrocortisone (98% agreement). Continuous IVCS infusion has no advantage over bolus administration (100% agreement).IVCS leads to clinical improvement in ~70% of paediatric ASC patients and its advent in the landmark trial of Truelove and Witts was the most important factor in the reduced mortality rate in ASC during the last century PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UcnVlbG92ZTwvQXV0aG9yPjxZZWFyPjE5NTk8L1llYXI+
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ADDIN EN.CITE.DATA (11, 152, 153). Trials in adults with ASC have shown similar efficacy of adrenocorticotropic hormone (ACTH) to hydrocortisone PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5NZXllcnM8L0F1dGhvcj48WWVhcj4xOTg3PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (147, 154-158).In a RCT in ambulatory adult patients, remission rate was higher in patients given oral prednisone 60mg or 40mg daily vs 20mg daily. Side effects were higher among patients given 60mg daily ADDIN EN.CITE <EndNote><Cite><Author>Baron</Author><Year>1962</Year><RecNum>360</RecNum><DisplayText>(159)</DisplayText><record><rec-number>360</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">360</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Baron, J. H.</author><author>Connell, A. M.</author><author>Kanaghinis, T. G.</author><author>Lennard-Jones, J. E.</author><author>Jones, A. F.</author></authors></contributors><titles><title>Out-patient treatment of ulcerative colitis. Comparison between three doses of oral prednisone</title><secondary-title>Br Med J</secondary-title></titles><periodical><full-title>Br Med J</full-title></periodical><pages>441-3</pages><volume>2</volume><number>5302</number><keywords><keyword>Colitis, Ulcerative/*therapy</keyword><keyword>Prednisone/*therapy</keyword></keywords><dates><year>1962</year><pub-dates><date>Aug 18</date></pub-dates></dates><accession-num>13865152</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>(159). In a meta-regression of cohorts studies in ASC, mainly in adults, colectomy rate did not correlate with methylprednisolone dose at or above 60mg/day as reported in the individual manuscripts ADDIN EN.CITE <EndNote><Cite><Author>Turner</Author><Year>2007</Year><RecNum>334</RecNum><DisplayText>(12)</DisplayText><record><rec-number>334</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">334</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Turner, D.</author><author>Walsh, C. M.</author><author>Steinhart, A. H.</author><author>Griffiths, A. M.</author></authors></contributors><titles><title>Response to corticosteroids in severe ulcerative colitis: a systematic review of the literature and a meta-regression</title><secondary-title>Clin Gastroenterol Hepatol</secondary-title></titles><periodical><full-title>Clin Gastroenterol Hepatol</full-title></periodical><pages>103-10</pages><volume>5</volume><number>1</number><dates><year>2007</year></dates><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>(12).A prospective multicenter cohort study in children with ASC (the OSCI study) showed that more than 70% of patients responded to daily methylprednisolone dose of 1-1.5 mg/kg (up to 40-60 mg) with no statistical difference in dose between responders and non-responders PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UdXJuZXI8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (164, 165). It could be concluded that the vast majority of evidence suggests that 40 mg is not less effective than higher doses in ASC but, given the few anecdotal reports and the severity of ASC, it is not unreasonable to dose higher in selected patients for several days until response has been achieved. Powell-Tuck et al. reported comparable efficacy and safety of once daily oral 40mg prednisolone to four divided doses in ambulatory UC and this has been traditionally extrapolated to the acute severe setting ADDIN EN.CITE <EndNote><Cite><Author>Powelltuck</Author><Year>1978</Year><RecNum>4822</RecNum><DisplayText>(166)</DisplayText><record><rec-number>4822</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803891">4822</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Powelltuck, J.</author><author>Bown, R.L.</author><author>Lennardjones, J.E.</author></authors></contributors><titles><title>A comparison of oral prednisolone given as single or multiple daily doses for active proctocolitis</title><secondary-title>Scand J Gastroenterol</secondary-title></titles><periodical><full-title>Scand J Gastroenterol</full-title></periodical><pages>833-837</pages><volume>13</volume><number>7</number><dates><year>1978</year></dates><isbn>0036-5521</isbn><accession-num>ISI:A1978FW53700012</accession-num><urls><related-urls><url><Go to ISI>://A1978FW53700012</url></related-urls></urls><language>English</language></record></Cite></EndNote>(166). This has been supported by another study in adults with ASC, in which continuous steroid infusion had neither better efficacy nor safety than bolus administration ADDIN EN.CITE <EndNote><Cite><Author>Bossa</Author><Year>2007</Year><RecNum>357</RecNum><DisplayText>(149)</DisplayText><record><rec-number>357</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">357</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Bossa, F.</author><author>Fiorella, S.</author><author>Caruso, N.</author><author>Accadia, L.</author><author>Napolitano, G.</author><author>Valvano, M. R.</author><author>Andriulli, A.</author><author>Annese, V.</author></authors></contributors><auth-address>U.O. Gastroenterologia, Ospedale I.R.C.C.S. Casa Sollievo della Sofferenza, S. Giovanni Rotondo, Italy.</auth-address><titles><title>Continuous infusion versus bolus administration of steroids in severe attacks of ulcerative colitis: a randomized, double-blind trial</title><secondary-title>Am J Gastroenterol</secondary-title></titles><periodical><full-title>Am J Gastroenterol</full-title></periodical><pages>601-8</pages><volume>102</volume><number>3</number><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Colitis, Ulcerative/*drug therapy/pathology</keyword><keyword>Colonoscopy</keyword><keyword>Double-Blind Method</keyword><keyword>Female</keyword><keyword>Follow-Up Studies</keyword><keyword>Glucocorticoids/*administration & dosage/therapeutic use</keyword><keyword>Humans</keyword><keyword>Infusions, Intravenous</keyword><keyword>Injections, Intravenous</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Recurrence</keyword><keyword>Retrospective Studies</keyword><keyword>Severity of Illness Index</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2007</year><pub-dates><date>Mar</date></pub-dates></dates><accession-num>17156148</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>(149).Radiography and toxic megacolonRecommendationsAbdominal x-ray (AXR) should be performed upon admission with a low threshold especially in children with abdominal tenderness or distension, significant pain and those with systemic toxicity [EL4, adults EL4] (100% agreement)Children with toxic megacolon, defined in Table 3, should be evaluated promptly by surgeons and conservative management should only be considered in stable clinical conditions and in highly specialized centres under close monitoring; urgent colectomy is recommended if no improvement is apparent within 24-72 hours [EL4, adults EL4] (98% agreement)Practical pointsAn abdominal CT-scan or MRI may be indicated in patients without megacolon on AXR but who have signs of peritonitis or unexplained deterioration, to exclude a perforation (98% agreement).Evidence of transverse colon diameter >55 mm (or > 40 mm in children younger than 10 years) with signs of systemic toxicity are diagnostic of toxic megacolon in children. Features of systemic toxicity for diagnosing toxic megacolon in children include fever, tachycardia, dehydration, electrolyte disturbance, altered level of consciousness, and hypotension; steroids may mask peritoneal signs (100% agreement).The initial management of toxic megacolon includes, in addition to IVCS, intravenous fluid resuscitation, intravenous antibiotics (covering Gram-negative and anaerobic bacteria e.g. ampicillin, gentamycin and metronidazole), bowel rest and preparation for surgery. Insertion of a nasogastric tube, and rectal decompression tube as well as positional changes have been used in adults but supportive evidence is absent in children. Oral vancomycin may be considered until C. difficile status is known (100% agreement). Cyclosporine, tacrolimus and anti-TNFs are not recommended in the routine management of toxic megacolon although several successful case reports have been published (100% agreement).Toxic megacolon is a rare complication of ASC, occurring in 1-2% of paediatric ASC PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SdXNzZWxsPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48
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A total of 17 predefined questions were addressed by working subgroups based on a systematic review of the literature. RESULTS: The recommendations and practice points were eventually endorsed with a consensus rate of at least 95% regarding: definitions, initial evaluation, standard therapy, timing of second-line therapy, the role of endoscopic evaluation and heparin prophylaxis, how to administer second-line medical therapy, how to assess response, surgical considerations, and discharge recommendations. A management flowchart is presented based on daily scoring of the Pediatric Ulcerative Colitis Activity Index (PUCAI), along with 28 formal recommendations and 34 practice points. CONCLUSIONS: These guidelines provide clinically useful points to guide the management of ASC in children. 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ADDIN EN.CITE.DATA (85) ADDIN EN.CITE <EndNote><Cite><Author>Jalan</Author><Year>1969</Year><RecNum>352</RecNum><DisplayText>(168)</DisplayText><record><rec-number>352</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">352</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Jalan, K. N.</author><author>Sircus, W.</author><author>Card, W. I.</author><author>Falconer, C. W.</author><author>Bruce, C. B.</author><author>Crean, G. P.</author><author>McManus, J. P.</author><author>Small, W. P.</author><author>Smith, A. N.</author></authors></contributors><titles><title>An experience of ulcerative colitis. I. Toxic dilation in 55 cases</title><secondary-title>Gastroenterology</secondary-title></titles><periodical><full-title>Gastroenterology</full-title></periodical><pages>68-82</pages><volume>57</volume><number>1</number><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Age Factors</keyword><keyword>Aged</keyword><keyword>Child</keyword><keyword>Colitis, Ulcerative/*complications/mortality</keyword><keyword>Colonic Diseases/*etiology/mortality</keyword><keyword>Dilatation/etiology</keyword><keyword>Female</keyword><keyword>Gastrointestinal Hemorrhage/etiology</keyword><keyword>Humans</keyword><keyword>Intestinal Perforation/etiology</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Prognosis</keyword><keyword>Sepsis/etiology</keyword><keyword>Sex Factors</keyword><keyword>Time Factors</keyword></keywords><dates><year>1969</year><pub-dates><date>Jul</date></pub-dates></dates><accession-num>5305933</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>(168). In adults, long rectal tube insertion combined with intermittent rolling manoeuvres ADDIN EN.CITE <EndNote><Cite><Author>Present</Author><Year>1988</Year><RecNum>1332</RecNum><DisplayText>(169)</DisplayText><record><rec-number>1332</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">1332</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Present, D.H.</author><author>Wolfson, D.</author><author>Gelernt, I.M.</author><author>Rubin, P.H.</author><author>Bauer, J.</author><author>Chapman, M.L.</author></authors></contributors><auth-address>Mount Sinai Medical Center, Department of Medicine and Surgery, New York, New York.</auth-address><titles><title>Medical decompression of toxic megacolon by "rolling". A new technique of decompression with favorable long-term follow-up</title><secondary-title>J Clin Gastroenterol</secondary-title><alt-title>J Clin Gastroenterol</alt-title></titles><periodical><full-title>J Clin Gastroenterol</full-title></periodical><alt-periodical><full-title>J Clin Gastroenterol</full-title></alt-periodical><pages>485-90</pages><volume>10</volume><number>5</number><keywords><keyword>Adult</keyword><keyword>*Colitis, Ulcerative/th [Therapy]</keyword><keyword>Female</keyword><keyword>Follow-Up Studies</keyword><keyword>Humans</keyword><keyword>*Intubation, Gastrointestinal</keyword><keyword>Male</keyword><keyword>Megacolon, Toxic/ra [Radiography]</keyword><keyword>*Megacolon, Toxic/th [Therapy]</keyword><keyword>*Posture</keyword><keyword>Time Factors</keyword></keywords><dates><year>1988</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>0192-0790</isbn><accession-num>3183326</accession-num><call-num>Held at Gerstein, U of Toronto</call-num><urls></urls><language>English</language></record></Cite></EndNote>(169) and the knee-elbow position ADDIN EN.CITE <EndNote><Cite><Author>Panos</Author><Year>1993</Year><RecNum>1929</RecNum><DisplayText>(170)</DisplayText><record><rec-number>1929</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">1929</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Panos, M. Z.</author><author>Wood, M. J.</author><author>Asquith, P.</author></authors></contributors><auth-address>Department of Medicine, University of Birmingham Medical School</auth-address><titles><title>Toxic megacolon: the knee-elbow position relieves bowel distension</title><secondary-title>Gut</secondary-title></titles><periodical><full-title>Gut</full-title></periodical><pages>1726-1727</pages><volume>34</volume><number>12</number><reprint-edition>NOT IN FILE</reprint-edition><keywords><keyword>Adult</keyword><keyword>blood</keyword><keyword>Colitis</keyword><keyword>complications</keyword><keyword>Dilatation,Pathologic</keyword><keyword>Gases</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Megacolon,Toxic</keyword><keyword>Middle Aged</keyword><keyword>Mortality</keyword><keyword>Posture</keyword><keyword>radiography</keyword><keyword>therapy</keyword></keywords><dates><year>1993</year></dates><isbn>0017-5749 (Print)</isbn><urls><related-urls><url>PM:8282262</url></related-urls></urls></record></Cite></EndNote>(170) have been used to promote decompression. 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ADDIN EN.CITE.DATA (175, 176), or hyperbaric oxygen ADDIN EN.CITE <EndNote><Cite><Author>Kuroki</Author><Year>1998</Year><RecNum>4830</RecNum><DisplayText>(177)</DisplayText><record><rec-number>4830</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803893">4830</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Kuroki, K</author><author>Masuda, A</author><author>Uehara, H</author><author>Kuroki, A</author></authors></contributors><titles><title>A new treatment for toxic megacolon</title><secondary-title>Lancet</secondary-title></titles><periodical><full-title>Lancet</full-title></periodical><pages>782</pages><volume>352</volume><number>9130</number><keywords><keyword>Administration, Oral</keyword><keyword>Adult</keyword><keyword>Anti-Inflammatory Agents</keyword><keyword>C-Reactive Protein</keyword><keyword>Colitis, Ulcerative</keyword><keyword>Humans</keyword><keyword>Hyperbaric Oxygenation</keyword><keyword>Interleukin-6</keyword><keyword>Male</keyword><keyword>Megacolon, Toxic</keyword><keyword>Prednisolone</keyword><keyword>administration & dosage</keyword><keyword>analysis</keyword><keyword>blood</keyword><keyword>complications</keyword><keyword>therapy</keyword></keywords><dates><year>1998</year></dates><accession-num>9737284</accession-num><urls></urls><language>ENG</language></record></Cite></EndNote>(177) for treating toxic megacolon, but the evidence is anecdotal. Although CMV infection is more commonly associated with toxic megacolon, there is not enough evidence to support empiric treatment with ganciclovir without confirmation of CMV infection ADDIN EN.CITE <EndNote><Cite><Author>Criscuoli</Author><Year>2015</Year><RecNum>4831</RecNum><DisplayText>(178)</DisplayText><record><rec-number>4831</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803893">4831</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Criscuoli, V.</author><author>Rizzuto, M.R.</author><author>Gallo, E.</author><author>Orlando, A.</author><author>Cottone, M.</author></authors></contributors><titles><title>Toxic megacolon and human Cytomegalovirus in a series of severe ulcerative colitis patients</title><secondary-title>J Clin Virol</secondary-title></titles><periodical><full-title>J Clin Virol</full-title></periodical><pages>103-106</pages><volume>66</volume><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Animals</keyword><keyword>Case-Control Studies</keyword><keyword>Colitis, Ulcerative</keyword><keyword>Comorbidity</keyword><keyword>Cytomegalovirus Infections</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Male</keyword><keyword>Megacolon, Toxic</keyword><keyword>Middle Aged</keyword><keyword>Prevalence</keyword><keyword>Retrospective Studies</keyword><keyword>Sicily</keyword><keyword>Tertiary Care Centers</keyword><keyword>Young Adult</keyword><keyword>complications</keyword><keyword>diagnosis</keyword><keyword>epidemiology</keyword><keyword>pathology</keyword></keywords><dates><year>2015</year></dates><accession-num>25866348</accession-num><urls></urls><electronic-resource-num>10.1016/j.jcv.2015.03.009</electronic-resource-num><language>ENG</language></record></Cite></EndNote>(178). Ultrasonography (US) by an experienced radiologist directed at the colonic wall may have a role in providing valuable information regarding the extent of disease and severity of inflammation. Civitelli et al’s study of 50 children with UC reported that bowel wall thickness, increased vascularity, loss of haustra and loss of stratification of the bowel wall independently predicted endoscopic severity ADDIN EN.CITE <EndNote><Cite><Author>Civitelli</Author><Year>2014</Year><RecNum>4249</RecNum><DisplayText>(179)</DisplayText><record><rec-number>4249</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1403718771">4249</key><key app="ENWeb" db-id="">0</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Civitelli, F.</author><author>Di Nardo, G.</author><author>Oliva, S.</author><author>Nuti, F.</author><author>Ferrari, F.</author><author>Dilillo, A.</author><author>Viola, F.</author><author>Pallotta, N.</author><author>Cucchiara, S.</author><author>Aloi, M.</author></authors></contributors><auth-address>Pediatric Gastroenterology and Liver Unit, Department of Pediatrics, Sapienza University of Rome, Rome, Italy.
Department of Internal Medicine and Medical Specialties, Sapienza University of Rome, Rome, Italy.
Pediatric Gastroenterology and Liver Unit, Department of Pediatrics, Sapienza University of Rome, Rome, Italy. Electronic address: marina.aloi@uniroma1.it.</auth-address><titles><title>Ultrasonography of the Colon in Pediatric Ulcerative Colitis: A Prospective, Blind, Comparative Study with Colonoscopy</title><secondary-title>J Pediatr</secondary-title><alt-title>The Journal of pediatrics</alt-title></titles><periodical><full-title>J Pediatr</full-title></periodical><pages>78-84</pages><volume>165</volume><number>1</number><dates><year>2014</year><pub-dates><date>Apr 8</date></pub-dates></dates><isbn>1097-6833 (Electronic)
0022-3476 (Linking)</isbn><accession-num>24725581</accession-num><urls><related-urls><url>;(179). Each of these four variables was assigned a value of 1 (present) or 0 (absent); a score >2 had a sensitivity of 100% and a specificity of 93% (area under ROC curve of 0.98) for predicting severe disease at endoscopy. The US score strongly correlated with clinical (PUCAI, r=0.90) and endoscopic disease activity (Mayo endoscopy sub-score, r=0.94). Monitoring disease and when to start 2nd line therapy (Figure 1)RecommendationsA PUCAI >45 points on the third day of IVCS treatment should dictate planning for second-line therapy between days 3-5 [EL2, adults EL2] (100% agreement)Second line therapy should be initiated on the fifth day of IVCS treatment in children with a PUCAI >65 points [EL2, adults EL2] (100% agreement)IVCS should be continued for an additional 2-5 days in children with a PUCAI of 35-65 on day 5; daily monitoring for confirming gradual response is recommended before a decision on second line therapy is made in most cases within a total of 7-10 days of treatment [EL2, adults EL2] (100% agreement)Practice pointsManagement of ASC may be initiated in local paediatric centres. Transfer to referral paediatric IBD centres should take place as needed but certainly by day 3 of IVCS in patients with a PUCAI >45 (95% agreement). Recommended planning for second line therapy between days 3-5 in non-responders (see section of 2nd line therapy) includes sigmoidoscopy (to detect infectious colitis (most notably CMV), granulomas and degree of inflammation), surgical consult, discussion with a stoma specialist, exclusion of latent tuberculosis, serology for HBV and HCV, and/or blood tests required prior to treatment with calcineurin inhibitors (creatinine, lipids and magnesium) (95% agreement). Frequent monitoring of laboratory tests (including complete blood count, CRP, ESR, albumin and electrolytes) is advisable as needed but at least at diagnosis and on days 3 and 5 thereafter. CRP, albumin, and ESR have some value to predict IVCS failure and should be monitored also for that purpose (100% agreement).Faecal inflammatory markers have no role in the diagnosis or management of ASC (95% agreement).Clinical guidelines for adults recommend that second-line therapy should be initiated if no response to IVCS is achieved within 3-10 days after initiation as further steroid treatment in non-responding patients is associated with complications PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IYXJib3JkPC9BdXRob3I+PFllYXI+MjAxNzwvWWVhcj48
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ADDIN EN.CITE.DATA (106). The most commonly employed adult prediction rule, the Oxford index, focuses on stool frequency and CRP at day 3 ADDIN EN.CITE <EndNote><Cite><Author>Travis</Author><Year>1996</Year><RecNum>52</RecNum><DisplayText>(180)</DisplayText><record><rec-number>52</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">52</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Travis, S. P.</author><author>Farrant, J. M.</author><author>Ricketts, C.</author><author>Nolan, D. J.</author><author>Mortensen, N. M.</author><author>Kettlewell, M. G.</author><author>Jewell, D. P.</author></authors></contributors><auth-address>Gastroenterology Unit, John Radcliffe Hospital, Oxford.</auth-address><titles><title>Predicting outcome in severe ulcerative colitis</title><secondary-title>Gut</secondary-title></titles><periodical><full-title>Gut</full-title></periodical><pages>905-10</pages><volume>38</volume><number>6</number><keywords><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Biological Markers</keyword><keyword>C-Reactive Protein/*analysis</keyword><keyword>Colectomy</keyword><keyword>Colitis, Ulcerative/radiography/surgery/*therapy</keyword><keyword>Cyclosporine/therapeutic use</keyword><keyword>Defecation</keyword><keyword>Feces</keyword><keyword>Female</keyword><keyword>Hospitalization</keyword><keyword>Humans</keyword><keyword>Immunosuppressive Agents/therapeutic use</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Predictive Value of Tests</keyword><keyword>Prognosis</keyword><keyword>Prospective Studies</keyword></keywords><dates><year>1996</year><pub-dates><date>Jun</date></pub-dates></dates><accession-num>8984031</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>(180). Other adult rules for predicting steroid refractoriness included also ESR, hemoglobin, albumin, transverse colon diameter on AXR and an Ulcerative Colitis Endoscopy Index of Severity (UCEIS) score 7 on admission PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Db3J0ZTwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (9, 10, 186). In a retrospective study of 99 children with ASC, the PUCAI performed better than the adult indices to differentiate responders from non-responders at days 3 and 5 of IVCS treatment PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UdXJuZXI8L0F1dGhvcj48WWVhcj4yMDA4PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (9). These findings were then validated in the OSCI study of 128 children with ASC PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UdXJuZXI8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (10). A PUCAI>45 points on day 3 predicted non-response to IVCS with a sensitivity of 92%, specificity of 50%, NPV of 94% and a PPV of 43%, indicating that complete response is anticipated in those with PUCAI ≤45. A PUCAI>70 points on day 5 was associated with IVCS failure with a specificity of 100%, PPV of 100%, sensitivity of 35% and NPV of 79%, indicating that response is highly unlikely in the presence of PUCAI>70. Using a cut-off of >65 points had a specificity of 96%, PPV 82%, sensitivity 49% and NPV 82% PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UdXJuZXI8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (10). Likewise, in a retrospective multicenter study of 153 adults, a PUCAI>45 points on day 3 had a NPV of 88% and PPV of 54% for salvage therapy (anti-TNF, cyclosporine or colectomy), whereas a PUCAI >65 on day 5 had a PPV of 85% and NPV of 72% ADDIN EN.CITE <EndNote><Cite><Author>Koslowsky</Author><Year>2014</Year><RecNum>4834</RecNum><DisplayText>(187)</DisplayText><record><rec-number>4834</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803894">4834</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Koslowsky, B</author><author>Gupta, A.</author><author>Livovsky, D.M.</author><author>Adar, T.</author><author>Turner, D.</author><author>Hartnell, F.</author><author>Pratico, C.</author><author>Travis, S.</author></authors></contributors><titles><title>The use of the Pediatric Ulcerative Colitis Activity Index (PUCAI) in adults with acute severe ulcerative colitis (ASC)</title><secondary-title>J Crohn Colitis</secondary-title></titles><periodical><full-title>J Crohn Colitis</full-title></periodical><pages>S108</pages><volume>8</volume><keywords><keyword>*adult</keyword><keyword>*colitis</keyword><keyword>*ulcerative colitis</keyword><keyword>algorithm</keyword><keyword>child</keyword><keyword>cohort analysis</keyword><keyword>colon resection</keyword><keyword>cyclosporin</keyword><keyword>hospitalization</keyword><keyword>human</keyword><keyword>male</keyword><keyword>patient</keyword><keyword>receiver operating characteristic</keyword><keyword>salvage therapy</keyword><keyword>screening</keyword><keyword>sigmoidoscopy</keyword><keyword>steroid</keyword><keyword>therapy</keyword><keyword>total colon resection</keyword><keyword>tuberculosis</keyword></keywords><dates><year>2014</year></dates><isbn>1873-9946</isbn><urls></urls></record></Cite></EndNote>(187). Although a small minority of children with a day 5 PUCAI>65 may respond eventually, delaying second-line therapy has the potential of increasing morbidity in ASC as shown both in children PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Tb29uPC9BdXRob3I+PFllYXI+MjAxMjwvWWVhcj48UmVj
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ADDIN EN.CITE.DATA (189). The PUCAI performed better than four faecal markers (calprotectin, lactoferrin, M2-pyruvate kinase (M2-PK) and S100A12), in predicting IVCS failure in paediatric ASC PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UdXJuZXI8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (190) and the microbiome pattern at day 3 ADDIN EN.CITE <EndNote><Cite><Author>Michail</Author><Year>2012</Year><RecNum>3534</RecNum><DisplayText>(191)</DisplayText><record><rec-number>3534</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1354729195">3534</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Michail, S.</author><author>Durbin, M.</author><author>Turner, D.</author><author>Griffiths, A. M.</author><author>Mack, D. R.</author><author>Hyams, J.</author><author>Leleiko, N.</author><author>Kenche, H.</author><author>Stolfi, A.</author><author>Wine, E.</author></authors></contributors><auth-address>Department of Pediatric Gastroenterology and Nutrition, University of Southern California, Los Angeles, California 90027, USA. Sonia.michail@</auth-address><titles><title>Alterations in the gut microbiome of children with severe ulcerative colitis</title><secondary-title>Inflamm Bowel Dis</secondary-title><alt-title>Inflammatory bowel diseases</alt-title></titles><periodical><full-title>Inflamm Bowel Dis</full-title></periodical><alt-periodical><full-title>Inflammatory Bowel Diseases</full-title></alt-periodical><pages>1799-808</pages><volume>18</volume><number>10</number><dates><year>2012</year><pub-dates><date>Oct</date></pub-dates></dates><isbn>1536-4844 (Electronic)
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ADDIN EN.CITE.DATA (167) reported that findings on AXR performed on 56 children with ASC during the first three days of admission were different between IVCS responders and non-responders (mucosal ulcerations: 3% vs 30%, p=0.006; mucosal tags: 9% vs 30%, p=0.073; and megacolon: 0% vs 13%, p=0.064). Anemia is of particular concern in ASC and blood transfusion should be considered when haemoglobin level is below 8mg/dL. Iron replacement without the need for transfusion should be considered in children whose rectal bleeding has ceased ADDIN EN.CITE <EndNote><Cite><Author>Fell</Author><Year>2016</Year><RecNum>5352</RecNum><DisplayText>(192)</DisplayText><record><rec-number>5352</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1517572717">5352</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Fell, J. M.</author><author>Muhammed, R.</author><author>Spray, C.</author><author>Crook, K.</author><author>Russell, R. K.</author><author>Bspghan Ibd working group</author></authors></contributors><auth-address>Department of Paediatric Gastroenterology, Chelsea and Westminster Hospital NHS Foundation Trust, London, UK.
Department of Paediatric Gastroenterology, Birmingham Children's Hospital NHS Foundation Trust, Birmingham, UK.
Department of Paediatric Gastroenterology, Bristol Royal Hospital for Children, Bristol, UK.
Department of Paediatric Gastroenterology, Northwick Park Hospital, London, UK.
Department of Paediatric Gastroenterology, The Royal Hospital for Children, Glasgow, UK.</auth-address><titles><title>Management of ulcerative colitis</title><secondary-title>Arch Dis Child</secondary-title><alt-title>Archives of disease in childhood</alt-title></titles><periodical><full-title>Arch Dis Child</full-title></periodical><pages>469-74</pages><volume>101</volume><number>5</number><keywords><keyword>Child</keyword><keyword>Colitis, Ulcerative/diagnosis/*therapy</keyword><keyword>Disease Management</keyword><keyword>Humans</keyword><keyword>Severity of Illness Index</keyword></keywords><dates><year>2016</year><pub-dates><date>May</date></pub-dates></dates><isbn>1468-2044 (Electronic)
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ADDIN EN.CITE.DATA (193). Generally, there is no need to correct hypoalbuminemia by albumin infusion unless the reduced oncotic pressure is associated with clinically significant complications (e.g. pulmonary edema, pleural infusions, or dyspnoea). Although hypoalbuminemia is associated with a decrease effectiveness of infliximab treatment, there are no published data that infusing albumin prior to infliximab administration improves outcome.WHEN STEROIDS FAILMedical second-line therapiesRecommendationsInfliximab is recommended as the second-line medical therapy for anti-TNF naive children failing IVCS [EL3, adults EL1] (100% agreement)Calcineurin inhibitors (tacrolimus and cyclosporine) can be considered as an alternative second-line medical therapy [EL4, adults EL1] (100% agreement)When introducing second-line therapy, the possibility of non-response and therefore need for colectomy must always be discussed [EL4, adults EL4] (100% agreement)Practice points:The role of cyclosporine or tacrolimus as a rescue therapy is only as a bridge to long-term maintenance therapy. Hence, among steroid-refractory patients who have failed prior thiopurine maintenance therapy, infliximab is the preferred second-line medical therapy, unless bridging to vedolizumab is being considered (100% agreement). Dosing and target levels for infliximab, cyclosporine, and tacrolimus are given in Table 2. Other biologics (e.g. other anti-TNF regimens and vedolizumab) have not been studied in hospitalized steroid-refractory patients and thus should be generally avoided as induction treatments in this setting (100% agreement).Due to rapid clearance of infliximab in ASC, intensification of induction regimen is often needed to provide drug exposure equivalent to that attained with standard dosing outside the ASC setting. Doses of infliximab up to 10 mg/kg/dose may be considered and may be given more frequently than usual (e.g. weeks 0, 1, and 4-5). Drug levels obtained during induction may guide maximization of efficacy (95% agreement).Response to infliximab or calcineurin inhibitors should be judged daily by PUCAI and with attention to serum CRP and albumin. Significant response (PUCAI drop of at least 20 points) is anticipated within 4-7 days with either therapy (100% agreement).To reduce unnecessary immunosuppression, corticosteroids (which have been ineffective) should be weaned following introduction to second-line therapy or decision to proceed to colectomy. The taper strategy should be individualized based on the prior steroid exposure and the clinical status (100% agreement). Among responders to intensified induction, subsequent doses of infliximab during maintenance phase can often be gradually lowered and adjusted to standard dosing, ideally guided by therapeutic drug monitoring (100% agreement).Children who develop steroid-refractory ASC are at particular risk for colectomy within one year. Therefore, the addition of an immunomodulator is recommended in responders to infliximab for at least six months. Thiopurine therapy is preferred over methotrexate in UC given its superior effect on treating the colitis itself. The latter, however, is associated with reduced risk for lymphoma and thus the risk-benefit ratio should be individually balanced (100% agreement).It is essential that ineffective steroid therapy is not prolonged unduly and that therapeutic alternatives are considered early, utilizing a PUCAI-based algorithm on days 3 and 5. Both infliximab and calcineurin inhibitors are equally effective in inducing clinical remission in ASC in both children ADDIN EN.CITE <EndNote><Cite><Author>Turner</Author><Year>2011</Year><RecNum>1610</RecNum><DisplayText>(11)</DisplayText><record><rec-number>1610</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">1610</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Turner, D.</author><author>Griffiths, A. M.</author></authors></contributors><auth-address>Pediatric Gastroenterology Unit, Shaare Zedek Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel. turnerd@.il</auth-address><titles><title>Acute severe ulcerative colitis in children: a systematic review</title><secondary-title>Inflamm Bowel Dis</secondary-title></titles><periodical><full-title>Inflamm Bowel Dis</full-title></periodical><pages>440-9</pages><volume>17</volume><number>1</number><edition>2010/07/21</edition><dates><year>2011</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>1536-4844 (Electronic)
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ADDIN EN.CITE.DATA (183). Observational studies among adult patients have reported short-term colectomy rates after rescue therapy with infliximab ranging from 20% to 75% PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb3NlbjwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+PFJl
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ADDIN EN.CITE PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Sb3NlbjwvQXV0aG9yPjxZZWFyPjIwMTU8L1llYXI+PFJl
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ZE5vdGU+AG==
ADDIN EN.CITE.DATA (196). In the only prospective multicentre cohort study of ASC in children, the OSCI study, 33 of those failing IVCS received infliximab as rescue therapy, of whom 76% were able to be discharged without colectomy and the cumulative 1-year sustained response rate was 55% (18/33) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UdXJuZXI8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (186, 198). Other case series have reported the use of infliximab in children with ASC, with pooled short-term response rate of 75% (95%CI 67-83); (n = 126, six studies) and a pooled 1‐year response of 64% (95%CI 56–72) ADDIN EN.CITE <EndNote><Cite><Author>Turner</Author><Year>2011</Year><RecNum>1610</RecNum><DisplayText>(11)</DisplayText><record><rec-number>1610</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">1610</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Turner, D.</author><author>Griffiths, A. M.</author></authors></contributors><auth-address>Pediatric Gastroenterology Unit, Shaare Zedek Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel. turnerd@.il</auth-address><titles><title>Acute severe ulcerative colitis in children: a systematic review</title><secondary-title>Inflamm Bowel Dis</secondary-title></titles><periodical><full-title>Inflamm Bowel Dis</full-title></periodical><pages>440-9</pages><volume>17</volume><number>1</number><edition>2010/07/21</edition><dates><year>2011</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>1536-4844 (Electronic)
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ADDIN EN.CITE.DATA (200). High concentrations of circulating and tissue TNF may act as a ‘sponge’ that rapidly absorbs or neutralises anti-TNF ADDIN EN.CITE <EndNote><Cite><Author>Yarur</Author><Year>2016</Year><RecNum>5356</RecNum><DisplayText>(201)</DisplayText><record><rec-number>5356</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1518517268">5356</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Yarur, A. J.</author><author>Jain, A.</author><author>Sussman, D. A.</author><author>Barkin, J. S.</author><author>Quintero, M. A.</author><author>Princen, F.</author><author>Kirkland, R.</author><author>Deshpande, A. R.</author><author>Singh, S.</author><author>Abreu, M. T.</author></authors></contributors><auth-address>Division of Gastroenterology, Department of Medicine, University of Miami, Miller School of Medicine, Miami, Florida, USA.
Prometheus Laboratories, San Diego, California, USA.</auth-address><titles><title>The association of tissue anti-TNF drug levels with serological and endoscopic disease activity in inflammatory bowel disease: the ATLAS study</title><secondary-title>Gut</secondary-title><alt-title>Gut</alt-title></titles><periodical><full-title>Gut</full-title></periodical><alt-periodical><full-title>Gut</full-title></alt-periodical><pages>249-55</pages><volume>65</volume><number>2</number><keywords><keyword>Adalimumab/*analysis/blood</keyword><keyword>Cross-Sectional Studies</keyword><keyword>Humans</keyword><keyword>Inflammatory Bowel Diseases/*blood/drug therapy</keyword><keyword>Infliximab/*analysis/blood</keyword><keyword>Intestinal Mucosa/chemistry</keyword><keyword>Tumor Necrosis Factor-alpha/*analysis/blood</keyword></keywords><dates><year>2016</year><pub-dates><date>Feb</date></pub-dates></dates><isbn>1468-3288 (Electronic)
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ADDIN EN.CITE.DATA (202). In support of the need for intensive dosing, Ungar et al. found infliximab trough levels at day 14 to be significantly lower in adult patients with ASC compared with moderately severe UC patients PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5VbmdhcjwvQXV0aG9yPjxZZWFyPjIwMTY8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (200). Limited data exist concerning optimal target infliximab levels during induction in any UC patients, and particularly in the setting of ASC. Among 101 adult patients with UC (but including only 15 with ASC) treated with standard 5 mg/kg dosing at weeks 0, 2 and 6, a trough level of ≥15 ug/ml at week 6 best predicted likelihood of short-term mucosal healing (area under the ROC of 0.69) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5QYXBhbWljaGFlbDwvQXV0aG9yPjxZZWFyPjIwMTY8L1ll
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ADDIN EN.CITE.DATA (204). In retrospective analysis of a paediatric cohort of hospitalized patients with steroid-refractory UC, higher clinical remission rates and a lower colectomy rate at one year were observed with intensified versus standard dosing ADDIN EN.CITE <EndNote><Cite><Author>Church</Author><Year>2016</Year><RecNum>4842</RecNum><DisplayText>(205)</DisplayText><record><rec-number>4842</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803896">4842</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Ho, S.</author><author>Church, P.</author><author>Sharma, A.</author><author>Walters, T.</author><author>Frost, K.</author><author>Muise, A.</author><author>Griffiths, A.</author></authors></contributors><titles><title>Intensification of infliximab induction regimen improves response rate in steroid-refractory pediatric ulcerative colitis</title><secondary-title>Gastroenterology</secondary-title></titles><periodical><full-title>Gastroenterology</full-title></periodical><pages>pp S131-132</pages><volume>150</volume><number>4 suppl 1</number><dates><year>2016</year></dates><work-type>Manuscript in preparation</work-type><urls></urls></record></Cite></EndNote>(205). Cyclosporine In the first RCT on cyclosporine in ASC, Lichtiger et al reported that 9/11 patients improved on 4 mg/kg/day intravenous cyclosporine, whilst all 9 receiving placebo failed to improve. In a further trial among adults with acute severe UC, 73 patients (but not all failing IVCS) were randomised to either 2 mg/kg or 4 mg/kg of intravenous cyclosporine PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5WYW4gQXNzY2hlPC9BdXRob3I+PFllYXI+MjAwMzwvWWVh
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ADDIN EN.CITE.DATA (206). Response rates at day 8 were similar in both groups (83% and 82% respectively), with 9% coming to colectomy in the 2 mg/kg group and 13% in the 4mg/kg group, with the former, therefore, being the preferred dose. Pooled results from controlled and uncontrolled trials in adults suggest that 76%-85% of patients respond to intravenous cyclosporine and avoid colectomy in the short term, with a median time to response of 4 days ADDIN EN.CITE <EndNote><Cite><Author>Hindryckx</Author><Year>2016</Year><RecNum>4843</RecNum><DisplayText>(207)</DisplayText><record><rec-number>4843</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803897">4843</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hindryckx, P.</author><author>Jairath, V.</author><author>D'Haens, G.</author></authors></contributors><auth-address>Department of Gastroenterology, University Hospital of Ghent, De Pintelaan 185, 9000 Ghent, Belgium.
Department of Gastroenterology, Academic Medical Center, Meibergdreef 9, 1105 AZ Amsterdam-Zuidoost, Netherlands.
Robarts Clinical Trials, 100 Dundas Street, N6A 5B6 London, Ontario, Canada.
Department of Medicine, Division of Gastroenterology, University Hospital, 339 Windermere Road, N6A 5A5 London, Ontario, Canada.</auth-address><titles><title>Acute severe ulcerative colitis: from pathophysiology to clinical management</title><secondary-title>Nat Rev Gastroenterol Hepatol</secondary-title><alt-title>Nature reviews. Gastroenterology & hepatology</alt-title></titles><periodical><full-title>Nat Rev Gastroenterol Hepatol</full-title></periodical><pages>654-664</pages><volume>13</volume><number>11</number><dates><year>2016</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>1759-5053 (Electronic)
1759-5045 (Linking)</isbn><accession-num>27580687</accession-num><urls><related-urls><url>;(207). In a systematic review of paediatric non-randomized studies, the pooled short‐term success rate with cyclosporine was 81% [95%CI 76–86]; n = 94 from eight studies) ADDIN EN.CITE <EndNote><Cite><Author>Turner</Author><Year>2011</Year><RecNum>1610</RecNum><DisplayText>(11)</DisplayText><record><rec-number>1610</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">1610</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Turner, D.</author><author>Griffiths, A. M.</author></authors></contributors><auth-address>Pediatric Gastroenterology Unit, Shaare Zedek Medical Center, Hebrew University of Jerusalem, Jerusalem, Israel. turnerd@.il</auth-address><titles><title>Acute severe ulcerative colitis in children: a systematic review</title><secondary-title>Inflamm Bowel Dis</secondary-title></titles><periodical><full-title>Inflamm Bowel Dis</full-title></periodical><pages>440-9</pages><volume>17</volume><number>1</number><edition>2010/07/21</edition><dates><year>2011</year><pub-dates><date>Jan</date></pub-dates></dates><isbn>1536-4844 (Electronic)
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ADDIN EN.CITE.DATA (208). Clinical response rates were 68% and 38% in the high and low trough groups, respectively, and 10% in the placebo. Another RCT treated 62 patients with corticosteroid-refractory, moderate-to-severe UC with tacrolimus to trough levels of 10?15 ng/mL PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5PZ2F0YTwvQXV0aG9yPjxZZWFyPjIwMTI8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (209). Clinical response rate of 50% was noted in the tacrolimus group and 13% in the placebo group at week 2 (p=0.003). A systematic review has combined the data of these two trials and other observational studies, and demonstrated that clinical response at 2 weeks was significantly higher with tacrolimus compared with placebo (RR=4.61, 95%CI 2.09-10.2) especially in those treated with thiopurines in paralel. Colectomy-free rates at 1, 3, 6, and 12 months were 0.86, 0.84, 0.78, and 0.69 respectively ADDIN EN.CITE <EndNote><Cite><Author>Komaki</Author><Year>2016</Year><RecNum>4844</RecNum><DisplayText>(210)</DisplayText><record><rec-number>4844</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803897">4844</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Komaki, Y.</author><author>Komaki, F.</author><author>Ido, A.</author><author>Sakuraba, A.</author></authors></contributors><auth-address>Section of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Chicago, Chicago, IL, USA.
Digestive and Lifestyle Diseases, Kagoshima University Graduate School of Medical and Dental Sciences, Kagoshima, Japan.
Section of Gastroenterology, Hepatology and Nutrition, Department of Medicine, University of Chicago, Chicago, IL, USA, asakurab@medicine.bsd.uchicago.edu.</auth-address><titles><title>Efficacy and Safety of Tacrolimus Therapy for Active Ulcerative Colitis; A Systematic Review and Meta-analysis</title><secondary-title>J Crohns Colitis</secondary-title><alt-title>Journal of Crohn's & colitis</alt-title></titles><periodical><full-title>J Crohns Colitis</full-title></periodical><alt-periodical><full-title>Journal of Crohn's & Colitis</full-title></alt-periodical><pages>484-94</pages><volume>10</volume><number>4</number><dates><year>2016</year><pub-dates><date>Apr</date></pub-dates></dates><isbn>1876-4479 (Electronic)
1873-9946 (Linking)</isbn><accession-num>26645641</accession-num><urls><related-urls><url>;(210). Paediatric studies of tacrolimus as rescue therapy in ASC have been limited to retrospectively reported single-centre case series and one small multi-centre prospective study. In the latter, of 14 children with ASC, 69% responded to tacrolimus, but 44% of responders underwent colectomy by 1 year PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb3VzdmFyb3M8L0F1dGhvcj48WWVhcj4yMDAwPC9ZZWFy
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ADDIN EN.CITE.DATA (211). Short-term response rates, meaning hospital discharge without colectomy ranged between 60% and 90% in the retrospective case series, with at least 40-50% requiring surgery by one to two years PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5OYXZhcy1Mb3BlejwvQXV0aG9yPjxZZWFyPjIwMTQ8L1ll
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ADDIN EN.CITE.DATA (194, 195) and in meta-analysis of retrospective studies ADDIN EN.CITE <EndNote><Cite><Author>Narula</Author><Year>2016</Year><RecNum>4847</RecNum><DisplayText>(216)</DisplayText><record><rec-number>4847</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803897">4847</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Narula, N.</author><author>Marshall, J. K.</author><author>Colombel, J. F.</author><author>Leontiadis, G. I.</author><author>Williams, J. G.</author><author>Muqtadir, Z.</author><author>Reinisch, W.</author></authors></contributors><auth-address>Department of Medicine, Division of Gastroenterology, Farncombe Family Digestive Health Research Institute; McMaster University, Hamilton, Ontario, Canada.
Department of Medicine, Division of Gastroenterology, Icahn School of Medicine at Mount Sinai, New York, New York, USA.
School of Medicine, Swansea University, Singleton Park, Swansea, UK.</auth-address><titles><title>Systematic Review and Meta-Analysis: Infliximab or Cyclosporine as Rescue Therapy in Patients With Severe Ulcerative Colitis Refractory to Steroids</title><secondary-title>Am J Gastroenterol</secondary-title><alt-title>The American journal of gastroenterology</alt-title></titles><periodical><full-title>Am J Gastroenterol</full-title></periodical><alt-periodical><full-title>The American Journal of Gastroenterology</full-title></alt-periodical><pages>477-91</pages><volume>111</volume><number>4</number><dates><year>2016</year><pub-dates><date>Apr</date></pub-dates></dates><isbn>1572-0241 (Electronic)
0002-9270 (Linking)</isbn><accession-num>26856754</accession-num><urls><related-urls><url>;(216). The open label CYSIF trial showed that treatment failure at day 98 was reported in 60% patients with cyclosporine vs. 54% with infliximab (p=0.49). Colectomy rate by day 98 was 18% versus 21%, respectively (p=0.66) ADDIN EN.CITE <EndNote><Cite><Author>Laharie</Author><Year>2012</Year><RecNum>4262</RecNum><DisplayText>(194)</DisplayText><record><rec-number>4262</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1403718806">4262</key><key app="ENWeb" db-id="">0</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Laharie, David</author><author>Bourreille, Arnaud</author><author>Branche, Julien</author><author>Allez, Matthieu</author><author>Bouhnik, Yoram</author><author>Filippi, Jerome</author><author>Zerbib, Frank</author><author>Savoye, Guillaume</author><author>Nachury, Maria</author><author>Moreau, Jacques</author><author>Delchier, Jean-Charles</author><author>Cosnes, Jacques</author><author>Ricart, Elena</author><author>Dewit, Olivier</author><author>Lopez-Sanroman, Antonio</author><author>Dupas, Jean-Louis</author><author>Carbonnel, Franck</author><author>Bommelaer, Gilles</author><author>Coffin, Benoit</author><author>Roblin, Xavier</author><author>Van Assche, Gert</author><author>Esteve, Maria</author><author>F?rkkil?, Martti</author><author>Gisbert, Javier P.</author><author>Marteau, Philippe</author><author>Nahon, Stephane</author><author>de Vos, Martine</author><author>Franchimont, Denis</author><author>Mary, Jean-Yves</author><author>Colombel, Jean-Frederic</author><author>Lémann, Marc</author></authors></contributors><titles><title>Ciclosporin versus infliximab in patients with severe ulcerative colitis refractory to intravenous steroids: a parallel, open-label randomised controlled trial</title><secondary-title>The Lancet</secondary-title></titles><periodical><full-title>The Lancet</full-title></periodical><pages>1909-1915</pages><volume>380</volume><number>9857</number><dates><year>2012</year></dates><isbn>01406736</isbn><urls></urls><electronic-resource-num>10.1016/s0140-6736(12)61084-8</electronic-resource-num></record></Cite></EndNote>(194). Similarly, the randomised controlled Comparison Of iNfliximab and cyclosporine in STeroid Resistant Ulcerative Colitis (CONSTRUCT) trial found no significant difference regarding colectomy, mortality rates or the occurence of serious infections in 270 patients with steroid-resistant ASC treated with cyclosporine or infliximab ADDIN EN.CITE <EndNote><Cite><Author>Williams</Author><Year>2016</Year><RecNum>4846</RecNum><DisplayText>(195)</DisplayText><record><rec-number>4846</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486803897">4846</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Williams, J. G.</author><author>Alam, M. F.</author><author>Alrubaiy, L.</author><author>Clement, C.</author><author>Cohen, D.</author><author>Grey, M.</author><author>Hilton, M.</author><author>Hutchings, H. A.</author><author>Longo, M.</author><author>Morgan, J. M.</author><author>Rapport, F. L.</author><author>Seagrove, A. C.</author><author>Watkins, A.</author></authors></contributors><auth-address>Swansea University Medical School, Swansea University, Swansea, UK.
Swansea Centre for Health Economics, College of Human and Health Science, Swansea University, Swansea, UK.
Faculty of Health Sport and Science, University of South Wales, Pontypridd, UK.
Patient representative.</auth-address><titles><title>Comparison Of iNfliximab and ciclosporin in STeroid Resistant Ulcerative Colitis: pragmatic randomised Trial and economic evaluation (CONSTRUCT)</title><secondary-title>Health Technol Assess</secondary-title><alt-title>Health technology assessment</alt-title></titles><periodical><full-title>Health Technol Assess</full-title></periodical><pages>1-320</pages><volume>20</volume><number>44</number><dates><year>2016</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>2046-4924 (Electronic)
1366-5278 (Linking)</isbn><accession-num>27329657</accession-num><urls><related-urls><url>;(195). Close monitoring of cyclosporine and tacrolimus levels is required, given the narrow margin between therapeutic and toxic levels. The individual circumstances of each patient should be considered when deciding between options for salvage therapy. Calcineurin inhibitors should be avoided in patients with low cholesterol or magnesium in view of the increased risk for neurological side effects, in the presence of diabetes, and in those with azotemia given the potential for renal-toxicity. On the other hand, infliximab is more costly and if an exit strategy is available (thiopurines in those previously na?ve to thiopurines, or vedolizumab) then calcineurin inhibitors may be equally considered.Third line and sequential medical therapyRecommendationsIn general, prompt referral for urgent colectomy is recommended following failure of one second-line medical therapy [EL3, adult EL2] (95% agreement).Practice points n highly specialized centres and in selected non-fulminant cases, sequential therapy of calcineurin inhibitors after infliximab or vice versa might be considered after weaning off steroids since concomitant steroid therapy is the main contributor for infections. Steroid substitution therapy may be prescribed at physiological doses to avoid adrenal insufficiency when needed (95% agreement).Sequential therapy should not be considered unless an undetectable level of the previous drug has been documented (93% agreement). If sequential therapy is used, Pneumocystis jiroveci pneumonia (PJP) prophylaxis should be considered especially if triple immunosuppressive treatment is used (98% agreement). Third line medical therapy in ASC occurs when sequential medical therapy is used for salvage of the steroid-refractory patient – infliximab follows or is followed by a calcineurin inhibitor (cyclosporine or tacrolimus). This is a separate scenario from sequential therapy in the chronic active UC patient who is steroid-dependent or refractory. There have been no reports of 3rd line therapy in paediatric ASC to date in the literature. A systematic review of sequential therapy in adult ASC include 10 case series or cohort studies (314 participants), of which only one was prospective (but no RCT) ADDIN EN.CITE <EndNote><Cite><Author>Narula</Author><Year>2015</Year><RecNum>4848</RecNum><DisplayText>(217)</DisplayText><record><rec-number>4848</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1486804573">4848</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Narula, N.</author><author>Fine, M.</author><author>Colombel, J. F.</author><author>Marshall, J. K.</author><author>Reinisch, W.</author></authors></contributors><auth-address>*Division of Gastroenterology, Department of Medicine, Farncombe Family Digestive Health Research Institute, McMaster University, Hamilton, ON, Canada; and daggerDivision of Gastroenterology, Department of Medicine, Icahn School of Medicine at Mount Sinai Hospital, New York, New York.</auth-address><titles><title>Systematic Review: Sequential Rescue Therapy in Severe Ulcerative Colitis: Do the Benefits Outweigh the Risks?</title><secondary-title>Inflamm Bowel Dis</secondary-title></titles><periodical><full-title>Inflamm Bowel Dis</full-title></periodical><pages>1683-94</pages><volume>21</volume><number>7</number><keywords><keyword>Colectomy/*methods</keyword><keyword>Colitis, Ulcerative/diagnosis/*therapy</keyword><keyword>Gastrointestinal Agents/*therapeutic use</keyword><keyword>Humans</keyword><keyword>Immunosuppressive Agents/*therapeutic use</keyword><keyword>Salvage Therapy/*methods</keyword><keyword>Treatment Outcome</keyword></keywords><dates><year>2015</year><pub-dates><date>Jul</date></pub-dates></dates><isbn>1536-4844 (Electronic)
1078-0998 (Linking)</isbn><accession-num>25839775</accession-num><urls><related-urls><url>;(217). It should be noted that many of the source studies contained a mixture of chronically active UC as well as ASC cases. A short-term response was seen in 62% of patients (95%CI 57-68) and remission in 39% (95%CI 34-44); colectomy rates were 28% (95%CI 22-35) and 42% (95%CI 36-49) at 3 and 12 months, respectively. Adverse events occurred in 23% (95%CI 18-28), including serious infection in 7% and mortality in 1%. The review concluded that the risk of sequential therapy seems lower than initially reported. Given the potential for serious adverse events in these adult series and lack of paediatric studies, extrapolation from adults should follow the precautionary principal on this matter. It thus would be prudent to ensure that the levels of the 2nd line medication have cleared or nearly cleared before starting the 3rd line therapy in paediatric ASC. Further, multiple studies of IBD therapies have demonstrated that infectious complications are highest with concomitant corticosteroid therapy, and thus steroids must be weaned before 3rd line therapy is started. Until paediatric data are available, children with fulminant colitis who cannot safely wait until weaning must be referred without delay to colectomy. SYNTHESIS AND SUMMARYDischarge RecommendationsRecommendationsChildren should not be discharged from hospital unless the disease is at most mild (i.e. PUCAI <35 points) but preferably closer to remission (i.e. PUCAI <10 points) [EL3, adult EL3] (98% agreement)Thiopurine maintenance is generally recommended after ASC responsive to IVCS; exclusive mesalamine maintenance therapy could be considered if a response to steroids has been rapid and the patient was mesalamine na?ve prior to admission [EL4, adult EL3] (100% agreement)Patients responding to infliximab commenced during ASC should continue this drug as a maintenance treatment post discharge [EL2, adult EL2] (100% agreement)Practice points Before discharge, the following should be ensured: stable vital signs, adequate oral nutrition, stable haemoglobin, improving trend in inflammatory markers and albumin, toleration of oral medication, and discontinuation of pain-control medications at least 24 hours prior to discharge (100% agreement).Methylprednisolone should be converted prior to discharge to the biologically equivalent dose of prednisone. 1mg of methylprednisolone is equivalent to 1.25mg of prednisone (i.e. 40mg is equivalent to 50mg, respectively) (98% agreement).Thiopurines may take 10-14 weeks to have full therapeutic effect and should be introduced at full dose once the patient is responding to corticosteroids (details in Part 1 of these guidelines) (98% agreement). If cyclosporine or tacrolimus is commenced during ASC treatment this should be weaned within several months as a bridge to thiopurine or other maintenance medication, such as vedolizumab, to minimize adverse drug events (98% agreement).Pneumocystis jiroveci pneumonia (PJP) prophylaxis with trimethoprim-sulfamethoxazole should be considered for triple immunosuppression which includes anti-TNF or a calcineurin inhibitor plus 2 other immunosuppressants, mainly steroids. Trimethoprim-sulfamethoxazole dosing: 450mg/m2 twice daily for 3 days each week, (maximum daily dose 1.92g) either consecutive or alternate day dosing (note 480mg of trimethoprim-sulfamethoxazole consists of trimethoprim 80mg and sulfamethoxazole 400mg) (100% agreement). Oral iron supplements should be commenced after discharge in cases of anemia with haemoglobin ≥10g/dL and quiescent disease. Intravenous iron should be considered in severe anemia (i.e. <10g/dL), active disease or if oral supplements are not tolerated (98% agreement).Mesalamine may be introduced or re-introduced at discharge, as appropriate (100% agreement). Children should be reviewed clinically within 2-3 weeks of discharge post ASC and then as needed (98% agreement).The timing of discharge and tight monitoring of the management during the immediate post-discharge period are crucial for avoiding early recurrence. In a post hoc analysis of 37 children with UC commenced on infliximab (90% moderate-severe activity) a week 8 PUCAI <10 points best predicted those in steroid-free remission after 1 year ADDIN EN.CITE <EndNote><Cite><Author>Turner</Author><Year>2013</Year><RecNum>3634</RecNum><DisplayText>(218)</DisplayText><record><rec-number>3634</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1388658205">3634</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Turner, D.</author><author>Griffiths, A. M.</author><author>Veerman, G.</author><author>Johanns, J.</author><author>Damaraju, L.</author><author>Blank, M.</author><author>Hyams, J.</author></authors></contributors><auth-address>Pediatric Gastroenterology Unit, Shaare Zedek Medical Center, The Hebrew University of Jerusalem, Jerusalem, Israel. Electronic address: turnerd@.il.</auth-address><titles><title>Endoscopic and clinical variables that predict sustained remission in children with ulcerative colitis treated with infliximab</title><secondary-title>Clin Gastroenterol Hepatol</secondary-title><alt-title>Clinical gastroenterology and hepatology : the official clinical practice journal of the American Gastroenterological Association</alt-title></titles><periodical><full-title>Clin Gastroenterol Hepatol</full-title></periodical><pages>1460-5</pages><volume>11</volume><number>11</number><dates><year>2013</year><pub-dates><date>Nov</date></pub-dates></dates><isbn>1542-7714 (Electronic)
1542-3565 (Linking)</isbn><accession-num>23672831</accession-num><urls><related-urls><url>;(218). Fifty-three percent of children with a PUCAI<10 at week 8 compared with 20% otherwise were in remission (p=0.036). Similarly, in the recent prospective PROTECT study, 148 children with UC were admitted at diagnosis for ASC. Failure to be in clinical remission (PUCAI<10) by week 4 was highly associated with need for additional medical therapy by Week 12 (week 4 remission was achieved in 80% of those with steroid-free remission at week 12 vs. 49% of those with active disease at week 12 and only 6% of those who required additional therapy; p<0.0001) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IeWFtczwvQXV0aG9yPjxZZWFyPjIwMTc8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (10). Of the infliximab responders, 28% (7/25) were discharged in clinical remission (PUCAI <10 points) and 72% (18/25) had mild disease at most (PUCAI <35 points) at discharge. This is in keeping with a study which highlighted a median discharge PUCAI score of 25 points (IQR 15-30) following an admission for ASC PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SdXNzZWxsPC9BdXRob3I+PFllYXI+MjAxMzwvWWVhcj48
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ADDIN EN.CITE.DATA (15). In the adult literature there is evidence that achieving complete clinical remission (≤3 stools/day with no visible blood) during the index hospital admission improves long term outcome and delays the need for colectomy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Cb2ppYzwvQXV0aG9yPjxZZWFyPjIwMDk8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (220).Post paediatric ASC discharge, 49% of initial IVCS responders lost clinical response despite maintenance mesalamine or thiopurine therapy during the subsequent 1 year and 14% became steroid dependent PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UdXJuZXI8L0F1dGhvcj48WWVhcj4yMDEwPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (10). In order to limit steroid exposure to the minimum necessary, expert consensus steroid tapering algorithm has been proposed (see Table in Part 1 of these recommendations). Azathioprine has been shown to be superior to mesalamine in maintaining remission post IVCS in one small paediatric study ADDIN EN.CITE <EndNote><Cite><Author>Hernandez</Author><Year>2015</Year><RecNum>5175</RecNum><DisplayText>(221)</DisplayText><record><rec-number>5175</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1502389355">5175</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Hernandez, D.S.</author><author>Hernandez, C.R.</author><author>Muncunil, G.P.</author><author>Calderon, V.V.</author><author>Martin de Carpi, J.</author></authors></contributors><titles><title>Mesalamine versus azathioprine for maintenance treatment after steroid induced remission in pediatric ulcerative colitis</title><secondary-title>J Crohns Colitis</secondary-title></titles><periodical><full-title>J Crohns Colitis</full-title></periodical><pages>S397</pages><volume>9</volume><number> </number><dates><year>2015</year></dates><urls></urls></record></Cite></EndNote>(221). Two adult RCTs also showed superiority of thiopurines over mesalamine PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5BcmRpenpvbmU8L0F1dGhvcj48WWVhcj4yMDA2PC9ZZWFy
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ADDIN EN.CITE.DATA (222) ADDIN EN.CITE <EndNote><Cite><Author>Mate-Jimenez</Author><Year>2000</Year><RecNum>2012</RecNum><DisplayText>(223)</DisplayText><record><rec-number>2012</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">2012</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Mate-Jimenez, J.</author><author>Hermida, C.</author><author>Cantero-Perona, J.</author><author>Moreno-Otero, R.</author></authors></contributors><auth-address>Servicio de Aparato Digestivo, Hospital Universitario de la Princesa, Universidad Autonoma de Madrid, Spain</auth-address><titles><title>6-mercaptopurine or methotrexate added to prednisone induces and maintains remission in steroid-dependent inflammatory bowel disease</title><secondary-title>Eur J Gastroenterol Hepatol</secondary-title></titles><periodical><full-title>Eur J Gastroenterol Hepatol</full-title></periodical><pages>1227-1233</pages><volume>12</volume><number>11</number><reprint-edition>NOT IN FILE</reprint-edition><keywords><keyword>5-AMINOSALICYLIC ACID</keyword><keyword>6-Mercaptopurine</keyword><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Aged</keyword><keyword>Anti-Inflammatory Agents</keyword><keyword>Antimetabolites</keyword><keyword>Chi-Square Distribution</keyword><keyword>Colitis</keyword><keyword>Disease</keyword><keyword>drug therapy</keyword><keyword>Drug Therapy,Combination</keyword><keyword>Female</keyword><keyword>Humans</keyword><keyword>Inflammatory Bowel Diseases</keyword><keyword>Male</keyword><keyword>methods</keyword><keyword>Methotrexate</keyword><keyword>Middle Aged</keyword><keyword>Prednisone</keyword><keyword>Remission Induction</keyword><keyword>Survival Analysis</keyword><keyword>therapeutic use</keyword><keyword>Treatment Outcome</keyword><keyword>ULCERATIVE COLITIS</keyword></keywords><dates><year>2000</year></dates><isbn>0954-691X (Print)</isbn><urls><related-urls><url>PM:11111780</url></related-urls></urls></record></Cite></EndNote>(223). A combination of azathioprine with mesalamine leads to higher 6-TGN levels and improves the likelihood of avoiding rescue therapy at 2 years, as found in a prospective multicenter study PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5IeWFtczwvQXV0aG9yPjxZZWFyPjIwMTE8L1llYXI+PFJl
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ADDIN EN.CITE.DATA (213, 226). Success rate is higher in children who are treated with cyclosporine combined with immunomodulatory therapy prior to discharge with a pooled long term colectomy free rate of 71% (55-83%) PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UdXJuZXI8L0F1dGhvcj48WWVhcj4yMDExPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (229-233) consequently, maintenance with vedolizumab post discharge could be considered in those who failed thiopurines prior to salvage with calcineurin inhibitors. IBD patients are at an increased relative risk of Pneumocystic jiroveci (PJP) (HR, 2.96; 95% CI 1.75-4.29) but low absolute risk ADDIN EN.CITE <EndNote><Cite><Author>Long</Author><Year>2013</Year><RecNum>5178</RecNum><DisplayText>(234)</DisplayText><record><rec-number>5178</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1502389356">5178</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Long, M.D.</author><author>Farraye, F.A.</author><author>Okafor, P.N.</author><author>Martin, C.</author><author>Sandler, R.S.</author><author>Kappelman, M.D.</author></authors></contributors><auth-address>Long,Millie D. Division of Gastroenterology and Hepatology, Department of Medicine, University of North Carolina at Chapel Hill, Chapel Hill, North Carolina 27599-7080, USA. millie_long@med.unc.edu</auth-address><titles><title>Increased risk of pneumocystis jiroveci pneumonia among patients with inflammatory bowel disease</title><secondary-title>Inflamm Bowel Dis</secondary-title></titles><periodical><full-title>Inflamm Bowel Dis</full-title></periodical><pages>1018-24</pages><volume>19</volume><number>5</number><dates><year>2013</year></dates><accession-num>23478805</accession-num><work-type>Comparative Study
Research Support, N.I.H., Extramural
Research Support, Non-U.S. Gov't</work-type><urls><related-urls><url> Technologies</remote-database-provider></record></Cite></EndNote>(234). PJP has been described in IBD patients on corticosteroids, calcineurin inhibitors, thiopurines and anti-TNF agents PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CZXJuc3RlaW48L0F1dGhvcj48WWVhcj4xOTkzPC9ZZWFy
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ADDIN EN.CITE.DATA (241). There is only one paediatric IBD case report of PJP (associated with infliximab monotherapy) ADDIN EN.CITE <EndNote><Cite><Author>Tschudy</Author><Year>2010</Year><RecNum>5185</RecNum><DisplayText>(242)</DisplayText><record><rec-number>5185</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1502389356">5185</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Tschudy, J.</author><author>Michail, S.</author></authors></contributors><auth-address>Tschudy,James. Department of Pediatrics/Pediatric Gastroenterology, Wright State University Boonshoft School of Medicine, Dayton, OH, USA.</auth-address><titles><title>Disseminated histoplasmosis and pneumocystis pneumonia in a child with Crohn disease receiving infliximab</title><secondary-title>J Pediatr Gastroenterol Nutr</secondary-title></titles><periodical><full-title>J Pediatr Gastroenterol Nutr</full-title></periodical><pages>221-2</pages><volume>51</volume><number>2</number><dates><year>2010</year></dates><accession-num>20410844</accession-num><work-type>Case Reports</work-type><urls><related-urls><url> Technologies</remote-database-provider></record></Cite></EndNote>(242). Corticosteroids are a major contributor to PJP in the non-HIV population and the use of multiple immunosuppressive agents increases the risk further PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5Pa2Fmb3I8L0F1dGhvcj48WWVhcj4yMDEzPC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (243-246). To date, 162 cases of PJP are reported in the IBD and rheumatology literature associated with anti-TNF therapy with a 20-27% mortality rate PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5UYWtldWNoaTwvQXV0aG9yPjxZZWFyPjIwMDg8L1llYXI+
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ADDIN EN.CITE.DATA (234, 239, 240, 242, 247-256) ADDIN EN.CITE <EndNote><Cite><Author>Kaur</Author><Year>2007</Year><RecNum>5183</RecNum><DisplayText>(239)</DisplayText><record><rec-number>5183</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1502389356">5183</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Kaur, N.</author><author>Mahl, T. C.</author></authors></contributors><auth-address>Department of Internal Medicine, University of Michigan, Ann Arbor, MI, USA.</auth-address><titles><title>Pneumocystis jiroveci (carinii) pneumonia after infliximab therapy: a review of 84 cases</title><secondary-title>Dig Dis Sci</secondary-title></titles><periodical><full-title>Dig Dis Sci</full-title></periodical><pages>1481-4</pages><volume>52</volume><number>6</number><keywords><keyword>Adult</keyword><keyword>Adverse Drug Reaction Reporting Systems</keyword><keyword>Aged</keyword><keyword>Antibodies, Monoclonal/*adverse effects</keyword><keyword>Arthritis, Rheumatoid/drug therapy</keyword><keyword>Crohn Disease/drug therapy</keyword><keyword>Female</keyword><keyword>Gastrointestinal Agents/*adverse effects</keyword><keyword>Humans</keyword><keyword>Infliximab</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>*Pneumocystis jirovecii</keyword><keyword>Pneumonia, Pneumocystis/*chemically induced</keyword><keyword>Retrospective Studies</keyword><keyword>United States</keyword><keyword>United States Food and Drug Administration</keyword></keywords><dates><year>2007</year><pub-dates><date>Jun</date></pub-dates></dates><isbn>0163-2116 (Print)
0163-2116 (Linking)</isbn><accession-num>17429728</accession-num><urls><related-urls><url>;(239). A meta-analysis of prophylactic treatment with co-trimoxazole in patients with hematological cancers and transplant recipients reported a 91% reduction in PJP incidence ADDIN EN.CITE <EndNote><Cite><Author>Green</Author><Year>2007</Year><RecNum>5198</RecNum><DisplayText>(257)</DisplayText><record><rec-number>5198</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="1502389357">5198</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Green, H.</author><author>Paul, M.</author><author>Vidal, L.</author><author>Leibovici, L.</author></authors></contributors><auth-address>Unit of Infectious Diseases, Rabin Medical Centre, Beilison Hospital, Petah-Tikva 49100, Israel.</auth-address><titles><title>Prophylaxis of Pneumocystis pneumonia in immunocompromised non-HIV-infected patients: systematic review and meta-analysis of randomized controlled trials</title><secondary-title>Mayo Clin Proc</secondary-title></titles><periodical><full-title>Mayo Clin Proc</full-title></periodical><pages>1052-9</pages><volume>82</volume><number>9</number><keywords><keyword>Anti-Infective Agents/administration & dosage/*therapeutic use</keyword><keyword>Antibiotic Prophylaxis</keyword><keyword>Humans</keyword><keyword>*Immunocompromised Host</keyword><keyword>*Pneumocystis carinii</keyword><keyword>Pneumonia, Pneumocystis/mortality/*prevention & control</keyword><keyword>Randomized Controlled Trials as Topic</keyword><keyword>Treatment Outcome</keyword><keyword>Trimethoprim, Sulfamethoxazole Drug Combination/administration &</keyword><keyword>dosage/*therapeutic use</keyword></keywords><dates><year>2007</year><pub-dates><date>Sep</date></pub-dates></dates><isbn>0025-6196 (Print)
0025-6196 (Linking)</isbn><accession-num>17803871</accession-num><urls><related-urls><url>;(257). As there are no robust studies in children, benefits of treatment must be balanced against medication side effects. The ECCO opportunistic infection guidelines recommend PJP prophylaxis in IBD patients on triple immunosuppression with one of these being either a calcineurin inhibitor or anti-TNF therapy PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5SYWhpZXI8L0F1dGhvcj48WWVhcj4yMDE0PC9ZZWFyPjxS
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ADDIN EN.CITE.DATA (55). CONCLUSIONBased on systematic review of the literature and a consensus process, we yielded 24 recommendations and 43 practice points. We have attempted to provide some practical guidance even when data were insufficient. In these cases we emphasized that the guidance is based on common knowledge and experts' opinion. Recognizing the unique considerations in children, some of the recommendations are different than those published for adults. We have summarized the recommendations in a treatment algorithm; this must be used in conjunction with the supporting text (Figure 1). These clinical management guidelines were developed to assist practitioners at all levels of health care, while recognizing that each patient is unique. The recommendations may, thus, be subject to local practice patterns, but serve as a general framework for the management of ASC in children. The development of the guidelines should now be followed by dissemination of the information to clinical practice. QUALIFYING STATEMENT ESPGHAN and ECCO are not responsible for the practices of physicians and provides guidelines and position papers as indicators of best practice only. These guidelines may be revised as necessary to account for changes in technology, new data, or other aspects of clinical practice. These guidelines are intended to be an educational device to provide information that may assist clinicians in providing care to patients. These guidelines are not a rule and should not be construed as establishing a legal standard of care or as encouraging, advocating, requiring, or discouraging any particular treatment. Clinical decisions in any particular case involve a complex analysis of the patient’s condition and available courses of action. Therefore, clinical considerations may require taking a course of action that varies from these guidelines.ACKNOWLEDGMENTThe authors wish to thank the following individuals for their valuable assistance in preparing these guidelines: the national representatives of ECCO, the members of the IBD Interest and Porto group of ESPGHAN, Henkjan Verkade, Tamar Altaraz, Shoshana VilkLEGENDS to FIGUREFigure 1: Algorithm for management of acute severe pediatric UCFootnote: This is a guide to aid the clinician in the management of a pediatric patient with ASC for timely decision making. It acts as a guide only and does not replace clinical assessment for individual patients. It should be interpreted in conjunction with the text of the supporting plete blood count, electrolytes, liver enzymes, albumin, C-reactive protein, erythrocyte sedimentation rate, blood culture (if febrile)Stool culture, viruses and C. difficile toxinContinue normal diet if possible. If adequate oral intake is not tolerated, support with enteral tube feeding. If enteral tube feeding is not tolerated or in the presence of colonic dilatation or when surgery is imminent, then parenteral nutrition may be neededDilatation on plain abdominal X-ray is suggested by colonic width of >56mm in children older than 10 years of age and >40mm in younger children. Defined as toxic megacolon if associated with toxicity (table 3 in the text).NPO, nothing per-osRevised with permission from: Turner D, Travis SP, Griffiths AM et al. Consensus for Managing Acute Severe Ulcerative Colitis in Children: A Systematic Review and Joint Statement From ECCO, ESPGHAN, and the Porto IBD Working Group of ESPGHAN. American Journal of Gastroenterology 2011;106(4):574-88.REFERENCES ADDIN EN.REFLIST 1Turner D, Travis SP, Griffiths AM, et al. 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Pneumocystis jiroveci (carinii) pneumonia following a second infusion of infliximab in a patient with ulcerative colitis. Inflamm Bowel Dis 2009;15(2):315-6.257Green H, Paul M, Vidal L, et al. Prophylaxis of Pneumocystis pneumonia in immunocompromised non-HIV-infected patients: systematic review and meta-analysis of randomized controlled trials. Mayo Clin Proc 2007;82(9):1052-9.TABLESTable 1: Paediatric Ulcerative Colitis Activity Index (PUCAI)ITEMPOINTS1. Abdominal pain: No painPain can be ignoredPain cannot be ignored05102. Rectal bleedingNoneSmall amount only, in less than 50% of stoolsSmall amount with most stoolsLarge amount (>50% of the stool content)01020303. Stool consistency of most stoolsFormedPartially formedCompletely unformed05104. Number of stools per 24 hours0-23-56-8>80510155. Nocturnal stools (any episode causing wakening)NoYes0106. Activity levelNo limitation of activityOccasional limitation of activitySevere restricted activity0510SUM OF PUCAI (0-85)For User’s guide and cutoff values for response, remission, mild, moderate and severe disease activity, refer to the original study ADDIN EN.CITE <EndNote><Cite><Author>Turner</Author><Year>2007</Year><RecNum>1326</RecNum><DisplayText>(2)</DisplayText><record><rec-number>1326</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">1326</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Turner, D.</author><author>Otley, A. R.</author><author>Mack, D.</author><author>Hyams, J.</author><author>de Bruijne, J.</author><author>Uusoue, K.</author><author>Walters, T. D.</author><author>Zachos, M.</author><author>Mamula, P.</author><author>Beaton, D. E.</author><author>Steinhart, A. H.</author><author>Griffiths, A. M.</author></authors></contributors><auth-address>Division of Gastroenterology, Hepatology and Nutrition, the Hospital for Sick Children, University of Toronto, Toronto, Canada.</auth-address><titles><title>Development, validation, and evaluation of a pediatric ulcerative colitis activity index: a prospective multicenter study</title><secondary-title>Gastroenterology</secondary-title></titles><periodical><full-title>Gastroenterology</full-title></periodical><pages>423-32</pages><volume>133</volume><number>2</number><dates><year>2007</year></dates><isbn>0016-5085 (Print)</isbn><accession-num>17681163</accession-num><urls></urls></record></Cite></EndNote>(2).Table 2: Second-line rescue therapies in paediatric steroid-refractory acute severe UCInfliximabCyclosporineTacrolimusTests before treatmentExcluding tuberculosis; varicella, hepatitis B, and hepatitis C (and HIV when appropriate) serologySerum creatinine, glucose, electrolytes (including magnesium), serum cholesterolAs per cyclosporineInitial dosing5-10 mg/kg for dose 1 and consider repeat at week 1 and week 4. Emerging data in ASC indicate that intensified induction is more successful than standard 5 mg/kg given at weeks 0, 2, 6.2 mg/kg/day continuous intravenous infusion0.1 mg/kg/dose orally twice dailyMain toxicityInfusion reactions, immune suppression and rare opportunistic infectionsHypertension, hyperglycemia, hypomagnesemia, immune suppression, azotemia, seizures (dose and hypercholesterolemia dependent), hirsutismAs per cyclosporine, but without hirsutism.Additionally self-remitting tremor.Ongoing treatment following responseContinue regularly scheduled maintenance infusions (q 4-8 weeks), ideally guided by therapeutic drug monitoring Initiate thiopurines (or other agent to maintain remission) so that cyclosporine can be discontinued within several monthsInitiate thiopurines (or other agent to maintain remission) so that tacrolimus can be discontinued within several monthsTarget drug levels during inductionLimited data on target levels during inductionAim initially for 150-300 ng/mlAim initially for 10-15 ng/mlTarget levels once response achievedMinimum 5-10 ug/ml at trough during maintenance100-200 ng/ml once remission achieved5-7 ng/ml once remission achieved; longer duration treatment using lower levels of 2-5 have been reportedMonitoring/prevention of toxicityPJP prophylaxis to be strongly considered with calcineurin inhibitors, IMM and steroidsPJP prophylaxis to be strongly considered with calcineurin inhibitors, IMM and steroidsMonitor drug levels, creatinine, glucose, electrolytes (including magnesium), lipid levels, blood pressurePJP prophylaxis to be strongly considered with calcineurin inhibitors, IMM and steroidsMonitor drug levels, creatinine, glucose, electrolytes (including magnesium), lipid levels, blood pressureTable 3: Previously established adult and the currently suggested Paediatric criteria for diagnosis of toxic megacolon Adult criteria ADDIN EN.CITE <EndNote><Cite><Author>Jalan</Author><Year>1969</Year><RecNum>352</RecNum><DisplayText>(168)</DisplayText><record><rec-number>352</rec-number><foreign-keys><key app="EN" db-id="pvt9a2tr59wdebewwru5exxpz0wr0d5dav5x" timestamp="0">352</key></foreign-keys><ref-type name="Journal Article">17</ref-type><contributors><authors><author>Jalan, K. N.</author><author>Sircus, W.</author><author>Card, W. I.</author><author>Falconer, C. W.</author><author>Bruce, C. B.</author><author>Crean, G. P.</author><author>McManus, J. P.</author><author>Small, W. P.</author><author>Smith, A. N.</author></authors></contributors><titles><title>An experience of ulcerative colitis. I. Toxic dilation in 55 cases</title><secondary-title>Gastroenterology</secondary-title></titles><periodical><full-title>Gastroenterology</full-title></periodical><pages>68-82</pages><volume>57</volume><number>1</number><keywords><keyword>Adolescent</keyword><keyword>Adult</keyword><keyword>Age Factors</keyword><keyword>Aged</keyword><keyword>Child</keyword><keyword>Colitis, Ulcerative/*complications/mortality</keyword><keyword>Colonic Diseases/*etiology/mortality</keyword><keyword>Dilatation/etiology</keyword><keyword>Female</keyword><keyword>Gastrointestinal Hemorrhage/etiology</keyword><keyword>Humans</keyword><keyword>Intestinal Perforation/etiology</keyword><keyword>Male</keyword><keyword>Middle Aged</keyword><keyword>Prognosis</keyword><keyword>Sepsis/etiology</keyword><keyword>Sex Factors</keyword><keyword>Time Factors</keyword></keywords><dates><year>1969</year><pub-dates><date>Jul</date></pub-dates></dates><accession-num>5305933</accession-num><urls><related-urls><url> </url></related-urls></urls></record></Cite></EndNote>(168)Suggested Paediatric criteria PEVuZE5vdGU+PENpdGU+PEF1dGhvcj5CZW5jaGltb2w8L0F1dGhvcj48WWVhcj4yMDA4PC9ZZWFy
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ADDIN EN.CITE.DATA (85)A) Radiographic evidence of colonic distentionB) At least three of the following:1. Fever >38 degrees Celsius2. Heart rate >120/min3. Neutrophilic leukocytosis >10.5 x 108 /L4. AnemiaC) In addition to the above, at least one of the following:1. Dehydration2. Altered level of consciousness3. Electrolyte disturbances4. HypotensionRadiographic evidence of transverse colon diameter ≥56 mm (or >40mm in those <10 years)PLUSB) Evidence of systemic toxicity, such as:1. Fever >38 degrees Celsius2. Tachycardia (heart rate >2 SD above mean for age)3. Dehydration4. Electrolyte disturbance (sodium, potassium or chloride)5. Altered level of consciousness or coma6. Hypotension or shockReproduced with permission from Turner D, Travis SP, Griffiths AM et al. Consensus for Managing Acute Severe Ulcerative Colitis in Children: A Systematic Review and Joint Statement From ECCO, ESPGHAN, and the Porto IBD Working Group of ESPGHAN. American Journal of Gastroenterology 2011;106(4):574-88. ................
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