1 - Rajiv Gandhi University of Health Sciences
SYNOPSIS FOR PG DISSERTATION FOR MD/MS,
UNDER RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BENGALURU.
|NAME OF THE CANDIDATE |DR. HAJIRA TABASSUM MAJEED |
|AND |D/O H.G ABDUL MAJEED |
|ADDRESS |#690, 16TH MAIN ROAD, |
|(IN BLOCK LETTERS) |38TH CROSS, |
| |4TH ‘T’ BLOCK, JAYANAGAR |
| |BANGALORE – 560041 |
|NAME OF THE INSTITUTION |M S RAMAIAH MEDICAL COLLEGE, BANGALORE |
|COURSE OF THE STUDY AND SUBJECT |M.D. PAEDIATRICS |
RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,
BANGALORE, KARNATAKA
PROFORMA FOR REGISTRATION OF SUBJECT OF DISSERTATION
|1 |NAME OF THE CANDIDATE AND ADDRESS |DR. HAJIRA TABASSUM MAJEED |
| | |D/O H.G ABDUL MAJEED |
| | |#690, 16TH MAIN ROAD, 38TH CROSS |
| | |4TH ‘T’ BLOCK, JAYANAGAR |
| | |BANGALORE – 560041 |
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| | |DR. HAJIRA TABASSUM MAJEED |
| | |P.G IN PAEDIATRICS, |
| | |DEPT OF PAEDIATRICS, |
| |ADDRESS FOR CORRESPONDANCE |M. S. RAMAIAH MEDICAL COLLEGE, |
| | |BANGALORE – 54. |
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|2 |NAME OF THE INSTITUTION |M S RAMAIAH MEDICAL COLLEGE, BANGALORE |
|3 |COURSE OF THE STUDY AND SUBJECT |M.D. PAEDIATRICS |
|4 |DATE OF ADMISSION TO THE COURSE |31ST MAY 2012 |
|5 |TITLE OF THE TOPIC |
| |A STUDY OF ISOTONIC FLUIDS VERSUS HYPOTONIC FLUIDS AS MAINTENANCE FLUID THERAPY IN PEDIATRIC INTENSIVE CARE UNIT OF THE TERTIARY CARE |
| |HOSPITAL |
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|6 |BRIEF RESUME OF INTENDED WORK |
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| |6.1 INTRODUCTION AND NEED FOR STUDY: |
| |Fluid therapy is an important component of critical care therapy of children in the Pediatric intensive care unit. Intravenous |
| |fluid therapy is necessary to provide fluid requirement, nutrition and for administration of medications. However, despite the |
| |importance of fluid therapy in sick children, the optimum composition of IV fluids in pediatric patients remains a matter of |
| |concern. Both isotonic and hypotonic IV fluids are use. |
| |An isotonic solution is a solution whose composition is similar to that of plasma. Isotonic solutions have an osmolality of 293 |
| |to 297 mOsm/L1. Because isotonic solutions have the same concentration of solutes as plasma, infused isotonic solutions remains |
| |within the extra cellular fluid compartment and is distributed between the intravascular and interstitial spaces, thus increasing|
| |intravascular volume. Examples of isotonic solutions include 0.9% sodium chloride (0.9% NaCl), Ringer lactate, 5% dextrose in |
| |water (D5W). |
| |A hypotonic solution is a solution whose composition is lower than that of plasma. Hypotonic IV solutions have an osmolality less|
| |than 293 mOsm/L. The infusion of hypotonic crystalloid solutions lowers the serum osmolality within the vascular space, causing |
| |fluid to shift from the intravascular space to both the intracellular and interstitial spaces2. The osmotic change results in the|
| |body moving water from the intravascular space to the cells in an attempt to dilute the electrolytes. Examples of hypotonic |
| |fluids include 0.45% sodium chloride (0.45% NaCl), 0.33% sodium chloride, 0.2% sodium chloride, N/5 saline with dextrose |
| |(Isolyte-P) N/4 saline with dextrose and 2.5% dextrose in water. |
| |Hence we have decided to undertake study of isotonic versus hypotonic fluid therapy in patients admitted in the PICU on |
| |maintenance IV fluid therapy. |
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| |6.2 REVIEW OF LITERATURE |
| |Children admitted to the Paediatric Intensive Care require intravenous fluid therapy. Hypotonic and isotonic IV fluids are being |
| |used as maintenance therapy. Clinical practice guidelines continue to use the recommendations published 50 years ago in view of |
| |the theoretical risks attributed to isotonic IV fluids, for example hypernatremia, hypertension because of volemic increase and |
| |phlebitis because of supraphysiological osmolality3. However recent studies have proven that isotonic solutions are safer and |
| |prevent iatrogenic hyponatremia when compared to hypotonic solution. |
| |In study conducted by Montanana et al [2008]3, among 122 pediatric patients hospitalised in intensive care unit requiring |
| |maintainance fluid therapy,at 24hours ,the percentage of hyponatremia in hypotonic group was 20.6% as opposed to 5.1% in isotonic|
| |group(p=0.02). |
| |In a study conducted by Saba et al [2011]4 at Montreal Children's Hospital, sixteen children aged 3 months to 18 years were |
| |randomized into two groups. One group was given isotonic IV fluids(0.9% saline) whereas the other was given hypotonic IV |
| |fluids(0.45% saline).Results showed that serum sodium increased significantly in 0.9% group(+0.20mmol/L/h[IQR+0.03,+0.4];p=0.02) |
| |and increased but not significantly,in the 0.45%group(+0.08mmol/L/h[IQR-0.15,+0.16];p=0.07). It was thus concluded that isotonic |
| |saline is a safer alternative to traditional hypotonic solutions for intravenous (IV) maintenance fluids to prevent hyponatremia.|
| |A study was conducted by Neville et al [2006]5 at Sydney Children’s Hospital at the annual peak incidence of rotavirus infection.|
| |14 Children aged between 6 months and 14 years with a presumptive diagnosis of gastroenteritis were eligible for enrolment in the|
| |study and were treated with IV fluids.In those receiving N/2 saline,plasma sodium decreased by≥2mmol/l in 51% of normonatremic |
| |group compared to 13% in hyponatremic group(p20 kg |
| |7.2 METHODS OF COLLECTING DATA |
| |Sick children admitted to PICU and satisfy the inclusion criteria will be included in the study. The children will be assigned to|
| |either group A or group B as per the random number table for maintenance intravenous therapy. Group A children will be started on|
| |maintenance therapy with isotonic fluid (normal saline) and group B was administered hypotonic IVF( 5%isolyte-P). The maintenance|
| |fluid volume administered is as per the volumetric Holliday– Segar formula9. All children on maintenance fluid therapy will be |
| |monitored clinically for signs of fluid overload, features of hyponatremia/hypernatremia, and other significant clinical findings|
| |and managed accordingly. Serum electrolytes, blood glucose and blood pressure will be measured after beginning of fluid therapy. |
| |Plasma creatinine, urine specific gravity and urine electrolyte concentration will be measured at 0, 6 and 24 hours. Written |
| |informed consent will be obtained from parents of all patients assigned to the study. |
| |Those children who require modification of fluid rate (either restriction or liberalisation) will be dropped out of the study and|
| |will be managed as per their needs. If child develops hyponatremia or hypernatremia during the course of study, will be managed |
| |as per the standard recommendation protocol. |
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| |STATISTICAL ANALYSIS |
| |Statistical Analysis of different parameters: Descriptive statistics of serum electrolytes, blood glucose, blood pressure, plasma|
| |creatinine, urine specific gravity and urine electrolyte concentration would be analysed and it would be expressed in terms of |
| |mean and standard deviation or median with interquartile range. Independent sample ‘t’ test /Mann Whitney Test would be used to |
| |compare the serum electrolytes, blood glucose, blood pressure, plasma creatinine, urine specific gravity and urine electrolyte |
| |concentration between the hypotonic and isotonic groups. Chi square test should be used to compare the hyponatremia / |
| |hypernatremia proportion between the two groups. |
| |7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animals? |
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| |YES, as given above, all these investigations will be done. |
| |Informed consent will be taken. |
| |No animal intervention needed. |
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| |7.4 Has ethical clearance been obtained from ethical committee of your institution? |
| |YES. |
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|8 |LIST OF REFERENCES |
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| |Man Zhi, J. Tilak Ratnanather, Elvan Ceyhan,Aleksander S. Popel and William E. Brownell. Hypotonic swelling of |
| |salicylate-treated cochlear outer hair cells. PMC2007(2):[95-104]. Available from: |
| |URL: |
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| |K Choong, M E Kho, K Menon, and D Bohn. Hypotonic versus isotonic saline in hospitalised children: a systematic review. Arch Dis|
| |Child. 2006 (10): [828–835]. Available from: URL: |
| |P. A lvarez Montanana, V. Modesto i Alapont, A. Perez Ocon, P. Ortega Lopez, J. L. Lopez Prats, J. D. Toledo Parreno. The use|
| |of isotonic fluid as maintenance therapy prevents iatrogenic hyponatremia in pediatrics: A randomized, controlled open study. |
| |Pediatr Crit Care Med 2008 (9):[589-597]. Available from: URL: |
| |Thomas G Saba, James Fairbairn, Fiona Houghton, Diane Laforte and Bethany J Foster. A randomized controlled trial of isotonic |
| |versus hypotonic maintenance intravenous fluids in hospitalized children. BMC Pediatrics 2011 (11):[82] Available from: |
| |URL: |
| |Neville KA, Verge CF, Rosenberg AR. Isotonic is better than hypotonic saline for intravenous rehydration of children with |
| |gastroenteritis: A prospective randomised study. Arch Dis Child 2006 (91):[226–232] . Available from: URL: |
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| |Allen I. Arieff. Postoperative hyponatremic encephalopathy following elective surgery in children. Pediatric Anesthesia 1998 |
| |(8):[1-4]. Available from: URL: |
| |Moritz ML, Ayus JC. Prevention of hospital acquired hyponatremia: A case for using isotonic saline. Paediatrics 2003 |
| |(111):[227–230]. Available from: URL: |
| |Halberthal M, Halperin ML, Bohn D. Lesson of the week: Acute hyponatremia in children admitted to hospital. BMJ 2001 |
| |(322):[780–782]. Available from: URL: |
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| |Holliday MA, Segar WE. The maintenance need for water in parenteral fluid therapy. Paediatrics 1957 (19):[823–832]. Available |
| |from: URL: |
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|9 |SIGNATURE OF THE CANDIDATE | |
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|10 |REMARKS OF THE GUIDE | |
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|11 |11.1 |NAME & DESIGNATION OF THE GUIDE |Dr. KARUNAKARA B.P |
| | | |PROFESSOR & PEDIATRIC INTENSIVIST |
| | | |DEPARTMENT OF PAEDIATRICS |
| | | |M.S.RAMAIAH MEDICAL COLLEGE & |
| | | |HOSPITAL – BENGALURU |
| |11.2 |SIGNATURE | |
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| |11.3 |HEAD OF THE DEPARTMENT |Dr. MALLIKARJUNA H. B |
| | | |PROFESSOR AND HOD DEPARTMENT OF PAEDIATRICS |
| | | |M.S.RAMAIAH MEDICAL COLLEGE & |
| | | |HOSPITAL - BENGALURU |
| |11.4 |SIGNATURE | |
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|12 |REMARKS OF THE CHAIRMAN AND PRINCIPAL | |
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