Rajive Gandhi University of Health Sciences, Karnataka

RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA. BANGALORE

ANNEXURE-II

PROFORMA FOR REGISTRATION OF SUBJECT FOR DISSERTATION

1. Name of the candidate DR.VIJAY KUMAR H J and address No.201,BMCRI HOSTEL FOR MEN BOWRING HOSPITAL ROAD SHIVAJINAGAR BANGALORE-560001

2. Name of the institution Bangalore Medical College & Research Institute , Bangalore.

3. Course of study & M.D General Medicine subject

4. Date of admission 14-05-2012

5. Title of the topic Study of Serum Albumin and C-Reactive Protein as prognostic biomarkers in hospitalised patients with Community Acquired Pneumonia.

6) Brief resume of the intended work

6.1) Need For the Study: Pneumonia is an infection of the pulmonary parenchyma. Despite being the cause of significant morbidity and mortality, pneumonia is often misdiagnosed, mistreated, and underestimated. The incidence rates are highest at the extremes of age 1. Among hospitalized patients for community acquired pneumonia, in-hospital mortality is more. It can vary from indolent to fulminant in presentation and from mild to fatal in severity.

Albumin has many immune functions. Serum albumin concentration as a negative acute phase reactant, changes with each change in CRP( c-reactive protein) value.

Inflammation potentiates hypoalbuminemia by removing mechanisms that protect albumin levels and by increasing the fractional catabolic rate 2. CRP a pentraxin family acute phase reactant produced by liver in response to inflammation , whose levels mainly determined by production and the severity of the cause .

Need to identify the prognostic significance of biomarker CRP levels and serum albumin and their usefulness in determining the progression of disease & effectiveness of treatment. 6.2) Review of literature:

Lee JH,et al.in 2011 , studied the association of biochemical markers, such as

albumin and C-reactive protein (CRP), with mortality and the prognostic

performance of these markers combined with the pneumonia severity index

(PSI) in patients with community-acquired pneumonia (CAP). They found

Albumin and CRP were associated with 28-day mortality, and these markers

increased prognostic performance when combined with the PSI scale.3

Riquelme O R,et al in 2008 studied the prognostic factors of community

acquired pneumonia in elderly patients and showed that low serum albumin

(<3.4) were associated with high mortality.4

Ugajin M et al .in 2012 studied the correlation between blood urea & serum

albumin and clinical outcomes in community acquired pneumonia. They found

the ratio of the urea levels with albumin as independent predictors of mortality in

Dey AB, Nagarkar KM, Kumar V. studied the clinical profile and

predictors of outcome in adults with community acquired pneumonia,found Old

age, history of smoking, presence of chronic obstructive airways disease, late

presentation to hospital, systolic and diastolic hypotension, high blood urea, low

serum albumin and development of septic shock were associated with a higher

incidence of complications and a poorer prognosis.6 . Kang DR et al studied the risk factors of CAP in young soldiers found out that

the risk of CAP is significantly high in military trainees, with low levels of

cholesterol and albumin.7

6.3) Objectives of the study :

1.To study the prognostic significance of commonly used biomarkers serum

Albumin level and C-Reactive Protein in hospitalized patients with Community

Acquired Pneumonia.

2.To correlate the clinical and biomarker levels with the organism involved.

7. Materials and methods:

7.1: Source of data:

The study will be conducted on minimum of 50 patients admitted to hospitals affiliated to Bangalore Medical College & Research Institute, Bangalore.

7.2: Method of collection of data

• After admission of cases based on PORT (Pneumonia Outcome Research Trial )

/CURB-65 scores,a detailed history and clinical examination will be done along

with chest x-ray to establish the diagnosis. Routine haematological investigations

along with serum albumin & c-reactive protein levels on day 1,3 & 7/discharge

will be carried out. • The lab values of serum albumin & c-reactive protein will be analysed with the

clinical profile and outcome in these study groups.

The data will be compiled & appropriate statistical test will be applied.

• Period of study : November 2012 to October 2014 • Study design : Prospective study. • Statistical test : Appropriate statistical methods will be used.

Inclusion criteria:

1.Patients of age>18 years and both sexes.

2.Patients with community acquired pneumonia who are hospitalised based on

(Pneumonia Outcome Research Trial ) PORT/CURB 65 score.

Exclusion criteria:

Patients of age<18 years.

Patients with chronic liver /kidney disease.

Burns.

Malabsorbtion syndromes & Malnutrition status.

Diabetics.

Pregnancy& Lactation.

Patients with sepsis.

7.3 Does the study require any investigations or interventions to be conducted on patients or other humans or animal? If so please describe briefly- It does not require any intervention on animals.

Investigations to be done on patients a) Haematological: Haemoglobin, Total leucocyte count, Differential count, ESR.

b)Renal Parameters : Blood urea , Serum creatinine.

c)Liver function test.

d)Blood sugars.

e)Chest X-Ray.

f)Sputum-gram stain,AFB,culture sensitivity.

g) Serum albumin & c-reactive protein levels on day 1,3 & 7/discharge

Investigations in selected cases:

a. USG Abdomen

7.4 Has the ethical clearance been obtained from your institution in case of 7.3 – yes 8. List of references:

1) Dan L .Longo et al.Harrison’s principles of internal medicine- The Mc Graw –Hill

18th ed.2012;vol 2 :2130-1

2) Burl R Don,George a kaysen, Serum albumin:relationship to inflammation and

nutrition.seminars in dialysis.2004 Nov-Dec;17(6):432-37

3) Lee JH et al, Albumin and C-reactive protein have prognostic significance in

patients with community-acquired pneumonia. J Crit Care. 2011 Jun;26(3):287-94.

4) Riquelme O R et al Community-acquired pneumonia in the elderly: clinical and

nutritional aspects. Rev Med Chil. 2008 May;136(5):587-93.

5) Ugajin M et al. Blood urea nitrogen to serum albumin ratio independently predicts

mortality and severity of community-acquired pneumonia. Int J Gen Med.

2012;5:583-9.

6) Dey AB, Nagarkar KM, Kumar V. Clinical presentation and predictors of outcome

in adult patients with community-acquired pneumonia. Natl Med J India. 1997 Jul-

Aug;10(4):169-72.

7) Kang DR et al . Low levels of serum cholesterol and albumin and the risk of

community-acquired pneumonia in young soldiers. Int J Tuberc Lung Dis. 2008 Jan;12(1):26-32.

9. Signature of the candidate :

DR. VIJAY KUMAR H J

10. Remark of the guide:

Community Acquired Pneumonia is a very common acute medical condition which is

easily treatable . To know the prognostic factors in early part of illness will help to interfere

and intensify the treatment preventing mortality and morbidity.

Serial estimation of serum albumin & CRP will be useful ,not only to know the prognosis but

also helpful in management of the case. Hence I am recommending this study for dissertation. 11. Name and designation of

11.1 Guide : DR.RAVEENDRA K R , MD .

Associate Professor Department of Medicine Bangalore Medical College & Research Institute Bangalore.

11.2 Signature:

11.3 Co-guide (if any) – No

11.4 Signature: 11.5 HEAD OF THE DEPARTMENT DR.PRABHAKAR B, MD

Professor & Head, Department of Medicine, Bangalore Medical College & Research Institute Bangalore

11.6 Signature:

12.1 Remark of Chairman and Dean:

12.2 Signature: