PROFORMA FOR REGISTRATION OF SUBJECTS FOR …



PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION FOR RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, BENGALURU.

DISSERTATION PROPOSAL

A STUDY ON THE USEFULNESS OF PLASMA PROCALCITONIN IN PREDICTING SEVERITY IN ELDERLY PATIENTS WITH COMMUNITY-ACQUIRED PNEUMONIA

SUBMITTED BY,

Dr. AMAR PATIL

Post Graduate 1st Year

Department of General Medicine

Kempegowda Institute of Medical Sciences And Research Centre, Bengaluru- 560004

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BENGALURU, KARNATAKA.

ANNEXURE-II

SYNOPSIS PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

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|1 |NAME OF THE CANDIDATE AND ADDRESS |AMAR PATIL |

| | |S/O B.N.PATIL, “BHAGIRTHI NIVAS” |

| | |OPP AIRFORCE MESS, NILAJI MAL, |

| | |BELGAUM, KARNATAKA- 591124 |

| | | |

|2 |NAME OF THE INSTITUTE |KEMPEGOWDA INSTITUTE OF MEDICAL SCIENCES AND RESEARCH CENTRE, |

| | |BENGALURU-560004. |

| | | |

|3 |COURSE OF STUDY AND SUBJECT |MD- GENERAL MEDICINE |

| | | |

|4 |DATE OF ADMISSION TO COURSE |O6/06/2013 |

|5 |TITLE OF THE TOPIC |A Study On The Usefulness of Plasma Procalcitonin in Predicting Severity in |

| | |Elderly Patients with Community-Acquired Pneumonia |

BRIEF RESUME OF THE INTENDED WORK

6.1NEED FOR THE STUDY

Pneumonia is one of the most common diseases, leading to death among the elderly. Older people tend to develop different symptoms of pneumonia like subtle mental changes, when compared with young people, making it difficult for doctor.

Generally, a severity-based approach is recommended for the diagnosis and treatment of community-acquired pneumonia.1

Pneumonia severity index (PSI) and CURB-65 are widely used as severity scoring systems to treat and predict the prognosis. In addition to PSI and CURB-65, biological markers have been developed to predict the severity of pneumonia in patients during the early infection. 2

Among them, procalcitonin, a calcitonin precursor, has been reported as a useful indicator in assessment of severity of pneumonia.3,4

The use of procalcitonin was more evident for bacterial infections, including sepsis than local and viral infection as it facilitates not only assessment of severity but also identification of associated bacteria.5

Procalcitonin can also help reduce unwanted antibiotic treatment in nonbacterial pneumonias6

The Pneumonia Severity Index (PSI) is commonly used for risk stratification of patients with pneumonia. However, this parameter showed only moderate association with outcome prediction and was judged to be inadequate to guide clinical care measures to aid the early identification of patients with pneumonia are underdeveloped. Such measures are needed as patients with pneumonia are at high risk of death and would benefit from early adaption of therapy.

Procalcitonin (PCT), a relatively novel marker of infectious processes, has been shown to be associated with the severity of inflammation and prognosis during sepsis and septic shock 7

Procalcitonin(PCT) is a peptide precursor of hormone calcitonin. It is produced by parafollicular cells(C cells) of thyroid and by neuroendocrine cells of lung and the intestine.The level of procalcitonin in blood of healthy individuals is below level of detection (10pg/ml) The level of procalcitonin rises in response to a proinflammatory stimulus especially of bacterial origin. With the derangements that a severe infection brings, the blood levels of procalcitonin may rise to 100 mcg/L. Half life of procalcitonin 25 to 30 hours.8

6.2 REVIEW OF LITERATURE

1.In a study in Korea, it was shown that levels of procalcitonin are more useful than the levels of CRP or WBC to predict the severity of community acquired pneumonia. However,there was no association between the levels of procacitonin and mortality in elderly.9

2. The PCT serum levels may provide valuable support to the clinical diagnosis of CAP and aid in the differential diagnosis of bacterial and viral pneumonia. PCT is particularly useful because the results are obtained several days prior to the culture tests. These biomarkers also aid in identifying the low-risk patients who can be treated in outpatient environments10

3. A study in France in children with CAP showed, PCT is the best independent biologic predictor of favourable response to beta-lactam therapy in children hospitalized for CAP. Thus, a high PCT level is highly suggestive of pneumococcal aetiology. However, a 3-ng/mL cut-off does not seem compatible with daily medical practice, and additional research is needed to further define the role of PCT in managing CAP in children.11

4.. Procalcitonin may aid in the diagnosis of pneumonia, particularly in cases with high diagnostic uncertainty. Importantly, PCT may aid in the decision to administer antibiotic therapy to patients presenting with AHF in which clinical uncertainty exists regarding a superimposed bacterial infection.12

5. Another research results suggest that PCT provides additional information on the risk of VAP. Inclusion of PCT in diagnostic algorithms could improve their effectiveness 13

6. In a study New York hospital, Procalcitonin was found to be useful in COPD patients for alerting clinicians to invasive bacterial infections such as pneumonia but it does not distinguish bacterial from viral and noninfectious causes of AECOPD.14

7. A clinical rule based on symptoms and signs to predict pneumonia in patients presenting to primary care with acute cough performed best in patients with mild or severe clinical presentation. Addition of CRP concentration at the optimal cut off of >30 mg/L improved diagnostic information, but measurement of procalcitonin concentration did not add clinically relevant information in this group. 15

8. Under PCT guidance, antibiotic use was reduced and duration of antibiotic treatment was shortened in low-risk outpatients with CAP, without apparent harm.16

6.3 AIMS & OBJECTIVES OF THE STUDY

• Aims:

To evaluate the effectiveness of procalcitonin as a screening tool in assessing the severity and mortality risk in community-acquired pneumonia in elderly people.

• Objectives:

• To correlate procalcitonin levels with CURB-65 and PNEUMONIA SEVERITY INDEX and severity of pneumonia and outcome of patient’s health

7. MATERIALS AND METHOD

7.1 SOURCES OF DATA

Patients admitted with community acquired pneumonia above 65 years at KIMS, BANGALORE

7.1.1 RESEARCH DESIGN

A prospective observational study

7.2 METHODS OF DATA COLLECTION

Detailed history will be taken and patients will be examined thoroughly.

Written informed consent will be obtained from all the patient

Patients will undergo necessary investigations including blood routine including Hb , TC, DC, ESR, PROCALCITONIN and Biochemical routine including B. Urea, S. creatinine, S. Electrolytes and urine analysis.

Chest Xray and ECG. .

PSI levels and CURB-65 will be calculated to estimate the severity of pneumonia. PSI class≥IV and CURB-65 score≥2 are defined as severe pneumonia.

Sputum samples will be collected and evaluated to detect pathogenic bacteria of pneumonia

Any other investigations will be done if required based on history and other complaints

7.2.1 SAMPLING PROCEDURE

Purposive sampling technique.

7.2.2 SAMPLE SIZE

A total of 50 patients meeting the incusion and exclusion criteria will be studied .

CRITERIA FOR SAMPLE COLLECTION

7.2.3 INCLUSION CRITERIA

All patients who are aged > 65 years admitted in the KIMS hospital for community acquired pneumonia are eligible.

7.2.4 EXCLUSION CRITERIA

Patients with:

1. Immunocompramised state

7.2.5 TOOLS FOR DATA COLLECTION

Patient will be given a proforma to fill up and the objectives will be studied in detail by following up the patient till he is discharged or death.

7.2.6 PLAN FOR DATA ANALYSIS

Data obtained will be analysed in terms of objectives of the study using descriptive and inferential statistics.

7.2.7 TIME AND DURATION OF THE STUDY

One and half years including follow up time. From November 2013 to November 2015

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATION OR INTERVENTION TO BE CONDUCTED ON PATIENT OR OTHER HUMAN OR ANIMAL? IF SO, PLEASE DESCRIBE BRIEFLY.

YES, Patient has to undergo investigation as a part of this study

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR INSTITUTION?

YES

8.LIST OF REFERENCES

1. Loeb M. Pneumonia in older persons. Clin Infect Dis. 2003;37:1335–1339.

2. Mandell LA, Wunderink RG, Anzueto A, Bartlett JG, Campbell GD, Dean NC, et al. Infectious Diseases Society of America/American Thoracic Society consensus guidelines on the management of community-acquired pneumonia in adults. Clin Infect Dis. 2007;44(Suppl 2):S27–S72.

3. Hedlund J, Hansson LO. Procalcitonin and C-reactive protein levels in community-acquired pneumonia: correlation with etiology and prognosis. Infection. 2000;28:68–73.

4. Hausfater P, Garric S, Ayed SB, Rosenheim M, Bernard M, Riou B. Usefulness of procalcitonin as a marker of systemic infection in emergency department patients: a prospective study. Clin Infect Dis. 2002;34:895–901.

5. Ahn S, Kim WY, Yoon JY, Sohn CH, Seo DW, Kim SH, et al. Procalcitonin in 2009 H1N1 influenza pneumonia: role in differentiating from bacterial pneumonia. Tuberc Respir Dis. 2010;68:205–211.

6. Christ-Crain M, Stolz D, Bingisser R, Muller C, Miedinger D, Huber PR, et al. Procalcitonin guidance of antibiotic therapy in community-acquired pneumonia: a randomized trial. Am J Respir Crit Care Med. 2006;174:84–93

7. Tang BM, Eslick GD, Craig JC, McLean AS. Accuracy of procalcitonin for sepsis diagnosis in critically ill patients: systematic review and meta-analysis. Lancet Infect Dis. 2007;7:210–217.

8. Gilbert DN. Use of plasma procalcitonin levels as an adjunct to clinical microbiology. J Clin Microbiol. 2010;48:2325–2329.

9. Ji Hye Kim et al.Tuberc Respir Dis (Seoul) 2013 May;74(5):207-214

10. Renato Seligman, Luis Francisco Ramos-Lima, [...],Clinics (Sao Paulo). 2012 November; 67(11): 1321–1325.

doi: 10.6061/clinics/2012(11)17

11. Cohen JF, Leis A, Lecarpentier T et al. PLoS One. 2012;7(5):e36927. doi: 10.1371/journal.pone.0036927. Epub 2012 May 17.

12. Maisel A, Neath SX, Landsberg J, Mueller C, Eur J Heart Fail. 2012 Mar;14(3):278-86. doi: 10.1093/eurjhf/hfr177. Epub 2012 Feb 2.

13. Sotillo-Díaz JC, Bermejo-López E, García-Olivares P, Med Intensiva. 2013 Sep 12. pii: S0210-5691(13)00156-3. doi: 10.1016/j.medin.2013.07.001

14. Falsey AR, Becker KL, Swinburne AJ et al. Int J Chron Obstruct Pulmon Dis. 2012;7:127-35. doi: 10.2147/COPD.S29149.

15. Saskia F van Vugt, general practitioner , Berna D L Broekhuizen, et al BMJ. 2013; 346: f2450.

16. Long W, Deng X, Zhang Y, Lu G, Xie J, Tang J. Respirology. 2011 Jul;16(5):819-24. doi: 10.1111/j.1440-1843.2011.01978.x.

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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 AND DESIGNATION OF GUIDE |DR. H.V.NATARAJU |

| | |Professor and HOD of Medicine, |

| | |Kempegowda Institute of Medical Sciences and Research Centre, |

| | |Bengaluru-560004. |

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| |11.2 SIGNATURE | |

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| |11.3 HEAD OF THE DEPARTMENT |DR. H.V.NATARAJU |

| | |HOD & Professor of Medicine, |

| | |Kempegowda Institute of Medical Sciences and Research Centre, |

| | |Bengaluru-560004. |

| |11.4 REMARKS | |

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| |11.5 SIGNATURE | |

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|12 |12.1 REMARKS OF THE CHAIRMAN AND PRINCIPAL. | |

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| |12.2 SIGNATURE | |

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