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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA

ANNEXURE-11

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1. NAME OF THE

CANDIDATE AND

DR. KAVYA K

POST GRADUATE

DEPT OF GENERAL MEDICINE ,

ESIC MEDICAL COLLEGE AND PGIMSR ,

RAJAJINAGAR,

BENGALURU-560010

2. NAME OF THE

INSTITUTION

3. COURSE OF THE

STUDY AND SUBJECT M.D. – GENERAL MEDICINE

4. DATE OF ADMISSION

TO COURSE 31-05-2012

5. TITLE OF TOPIC

“AN OBSERVATIONAL STUDY OF ANAEMIA AND ITS

UNDERLYING CAUSES IN MEDICAL INTENSIVE CARE UNIT.”

BRIEF RESUME OF THE INTENDED STUDY:

6.1 NEED FOR THE STUDY:

Anemia is common in critically ill patients and appears early during their intensive

care unit (ICU) course. By day 3 after ICU admission, almost 95% of patients are anemic.[1–3] The anemia in these critically ill patients persists throughout their ICU and hospital

stay, with or without red blood cell (RBC) transfusion.[3]

Delivery of oxygen to tissues depends upon hemoglobin level and tissue perfusion

by oxygenated blood; anemia will lead to a decreased capacity of oxygen transport, which

is compensated by cardiac compensatory mechanisms. In critically ill patients these

mechanisms might not be sufficient eventually resulting in tissue hypoxia and progression

to multiple organ dysfunction syndromes. The presence of anemia patients in ICU has been

associated with worse outcomes including increased lengths of stay and increased

mortality.[4]

Anemia is a hemoglobin concentration in blood that is below the expected value,

when age, gender, pregnancy and certain environmental factors, such as altitude, are taken

into account. The World Health Organization (WHO) defines anemia as a hemoglobin

<13 g/dl (hematocrit <39%) for adult males and <12 g/dl (hematocrit <36%) for adult non-

pregnant females. [5, 6] There are no universally agreed grades of severity for anemia during

critical illness.

Among the causes of anemia in the critically ill, important are sepsis (inflammation)

induced bone marrow suppression, blood loss especially gastrointestinal bleeding, blood

sampling, chronic renal failure, drug-induced hemolytic anemia, nutritional deficiencies

and worm infestation.[7,8] Anemia of critical illness is similar as anemia of Inflammation

and anemia of chronic disease as it develops acutely in states of inflammation. Anemia of

inflammation is the second most common cause of anemia after iron deficiency.[9]

A proper identification of anemia and its underlying causes in ICU patients is required

because various disorders may necessitate different diagnostic and therapeutic management

strategies. It will be helpful to select appropriate treatment options like blood transfusion,

erythropoietin therapy, and iron supplementation which influence the outcome in these

critically ill patients.

6.2 REVIEW OF LITERATURE Corwin et. al study in the USA examined 489 admissions to ICUs the mean hemoglobin

concentration at ICU admission was 11.0 g/dl. Almost two-thirds of patients had a

hemoglobin concentration <12 g dl at ICU admission.[3]

Vincent et. al in a cohort study of 3534 patients admitted to 146 Western European

ICUs with varying case mix found that the mean hemoglobin concentration at ICU

admission was 11.3 g/dl. Sixty-three per cent of patients had a hemoglobin concentration

<12 g/dl on ICU admission and 29% of patients had an admission hemoglobin

concentration <10 g/dl.[4]

A cohort study by Bahlas S et. al., out of the 100 patients, 82% (82 patients) were

anemic with Hb average of 10.06 + 0.28, 48 of whom had blood transfusion. Sepsis was

the most common clinical setting associated with anemia in 72% of the patients followed

by Chronic Renal Failure in 56% of the patients. The others being gastrointestinal

bleeding, hemolysis and internal hemorrhage. [9]

Anemia is common in heart failure populations, with the majority of studies indicating

prevalence >20%. In most reported studies anemia is an independent predictor of increased

mortality risk and increased risk of hospitalization for heart failure.[10]

In a prospective cohort study by N Manchal, S Jayaram causes identified for anemia in

ICU were 33% due to sepsis, 9% due to chronic kidney disease,8% each for GI bleed,

internal bleed and protozoa infections.[11]

Tanne D et. al concluded in a cohort study as WHO-defined anemia was common in both

men and women among patients with acute stroke and predicted poor outcome.[12]

Hebert et al. studied 4,470 patients Critically ill patients admitted to ICU; survivors:

(n = 3,469), non-survivors: (n = 1,001) Survivors had higher Hb levels than non-survivors.[13]

6.3 OBJECTIVES OF THE STUDY1. To study occurrence of anemia among critically ill patients and its contribution to ICU

related morbidity.

2. To study the etiological factors that contributes to anemia in critically ill patients.

7 MATERIALS AND METHODS

7.1 SOURCE OF THE DATA The study includes patient selected from ICU at Employees State Insurance Corporation-

Medical Collage- Post Graduate Institute of Medical Sciences and Research [ESIC-MC-

PGIMSR] over a period of 18 months.

7.2 METHOD OF COLLECTION OF DATA Patients satisfying inclusion criteria are enrolled within 24 hours of admission to ICU

after informed consent.

Complete hemogram noted on first day, third day and at the time of discharge or transfer

from ICU.C-reactive protein measured on first day and at the time of discharge or transfer

Other investigations as advised by attending physician based on primary diagnosis are

noted as relevant to the study.

Sample size: 60

Study design: observational study

Statistical analysis: The data collected in this study will be analyzed statistically using

descriptive statistics.

INCLUSION CRITERIA:1. Patients aged above 18 years admitted under medicine department.[11]

2. Males with hemoglobin <13 g/dl (hematocrit <39%) and females with<12g/dl

(hematocrit <36%) [5,6]

3. APACHE II SCORE ≥ 20 on the day of admission[4,12] or Patient on mechanical

ventilator[13]

EXCLUSION CRITERIA:1. Patient under age 18 years

2. Patient with known congenital anaemias

3. HIV positive patients

4. Patient with known malignancy and on chemotherapy

5. Pregnant patients

7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR

INTERVENTIONS TO BE CONDUCTED IN PATIENTS OR OTHER

7.4 HAS ETHICAL CLEARANCE BEEN OBTAINED FROM YOUR

INSTITUTION :YES

8. REFERENCES:

1. Corwin HL, Gettinger A, Rodriguez RM, Pearl RG, Gubler KD, Enny C, Colton T,

Corwin MJ: Efficacy of recombinant human erythropoietin in the critically ill patient: a

randomized, double-blind, placebo-controlled trial. Crit Care Med 1999; 27:2346-2350.

2. Rodriguez RM, Corwin HL, Gettinger A, Corwin MJ, Gubler D, Pearl RG. Nutritional

deficiencies and blunted erythropoietin response as causes of the anemia of critical illness.

J Crit Care 2001; 16:36-41.

3. Corwin HL, Gettinger A, Pearl RG, Fink MP, Levy AM, Abraham E, MacIntyre NR,

Shabot M, Dun MS, Shapiro MJ. The CRIT study: Anemia and blood transfusion in the

critically ill: current clinical practice in the United States. Crit Care Med 2004; 32:39-52.

4. Vincent JL, Baron JF, Reinhart K, et al. Anaemia and blood transfusions in critically ill

patients. JAMA 2002; 288:1499–507.

5. Longo D L et al. Harrison´s Principles of Internal Medicine. 18 th edition. Vol.I. New

York: McGraw-Hill; 2012: 448-9.

6. Nutritional anaemia’s. Report of WHO scientific group. World Health Organ Tech Rep

Ser1968; 405:5-37.

7. Walsh T.S, Ezz-El-Din Saleh. Anaemia during critical illness. British Journal of

Anaesthesia 2006; 97 (3): 278–91.

8. Irwin, Richard S., Rippe, James M. Irwin and Rippe's Intensive Care Medicine. 7th

Edition. Lippincott Williams & Wilkins: 2011; Sec IX Chap 112:1253-4.

9. Bahlas S, Faydhi A , Ahmed M.A. Prospective Study on Anemia and Blood Transfusion

in Critically ill Patients.WebmedCentral GENERAL MEDICINE 2011; 2(4):WMC001836.

10. Tang Y, Katz SD. The prevalence of anemia in chronic heart failure and its impact on

the clinical outcomes. Heart Fail Rev. 2008 Dec; 13(4):387-92

11. Manchal N, Jayaram S. A prospective cohort study on anemia and blood transfusion in

critically ill patients. Indian J Crit Care Med 2007; 11:182-5.

12. Tanne D, Molshatzki N, Merzeliak O, Tsabari R, Toashi M, Schwammenthal Y.

Anaemia status, haemoglobin concentration and outcome after acute stroke: a cohort study.

BMC Neurol 2010; 10:22.

13. Hebert PC, Wells G, Tweeddale M, et al. Does transfusion practice affect mortality in

critically ill patients? Transfusion Requirements in Critical Care (TRICC) Investigators and

the Canadian Critical Care Trials Group. Am J Resp Crit Care Med 1997; 155:1618–1623.

14. Knaus WA, Draper EA, Wagner DP, Zimmerman JE. "APACHE II: a severity of

disease classification system". Critical Care Medicine 1985; 13 (10): 818–29.

15. Wang MP, Jiang L, Zhu B, Jiang Q, Xi XM. Clinical observational study of anemia in

mechanically ventilated patients. Zhongguo Wei Zhong Bing Ji Jiu Yi Xue 2012 Feb;

24(2): 70-3.

9. SIGNATURE OF CANDIDATE

10.REMARKS OF THE GUIDE:

Anemia in ICU has diagnostic and therapeutic implications. Hence study is relevant with practical implications.

11. 11.1 NAME AND DESIGNATION( IN BLOCK LETTERS) OFGUIDE

DR.T.ANIL KUMAR, MDPROFESSOR AND HEAD OF THE DEPARTMENT,DEPARTMENT OF GENERAL MEDICINE,ESIC-MC PGIMSR,RAJAJINAGAR,BENGALURU-560010

11.2 CO-GUIDE ( if any ) DR.V.SRINIVASA MURTHY, MDPROFESSOR AND HEAD OF THE DEPARTMENT,DEPARTMENT OF PATHOLOGY,ESIC-MC PGIMSR,RAJAJINAGAR,BENGALURU-560010

11.3 HEAD OF THE DEPARTMENT

11.4 SIGNATURE

11.5 REMARKS OF THE CHAIRMAN & PRINCIPAL

11.6 SIGNATURE

11.7 PRINCIPAL OF THE INSTITUTTION

Dr. B. RAJEEVA SHETTY, MSDEAN, ESIC MEDICAL COLLEGE & POSTGRADUATE INSTITUTE OF MEDICAL SCIENCE AND RESEARCH, RAJAJINAGAR, BENGALURU-560010

Case No: Hospital- IP / OP No:

Address: Occupation:

History of fever – type Duration Degree Associated factors History of cough –productive Non – productive History of burning micturition History of pain abdomen/ vomiting/loose stoolsHistory of blood in vomitus / stools / black tarry stoolsHistory of recent bleeding from any orifices- menstrual, gum bleeding or othersHistory of headache / altered sensorium

Co-morbidities- Hypertension/ diabetes/ chronic renal failure/ chronic obstructive pulmonary disease/ ischemic heart disease/ tuberculosis/ epilepsy/ cirrhosis of liver

PAST HISTORY -

GPE- General Physical Examination:

General appearance:

Height / weight Temperature

Pallor: Clubbing: Icterus: Cyanosis: Edema:

Pulse: BP: Respiratory rate: Saturation:

Systemic examination:

Investigations:

APACHE II score-Arterial blood gas analysis-

Mechanical ventilation-

1. Complete Hemogram:On day 1On day 3On day of discharge or transfer

On day 1On day of discharge or transfer

Other investigations as ordered by attending physician based on primary diagnosis:

PT, aPTT, INR Smear for MP, Serological tests for dengue, leptospirosis Liver function tests Renal function tests Thyroid function tests Iron studies Serum B12, Folic acid levels Bone marrow aspiration & biopsy Blood culture & sensitivity Urine routine analysis Urine culture & sensitivity Sputum gram stains & culture sensitivity Chest x ray Ultra sonogram

Other relevant investigations as required;

TREATMENT GIVEN;

Number of units of blood transfused:

CONSENT FORM

Participant’s name: Age: Sex:

Title of the study: AN OBSERVATIONAL STUDY OF ANAEMIA AND ITS ETIOLOGICAL PROFILE IN MEDICAL INTENSIVE CARE UNIT.

The details of the study have been provided to me in writing and explained to me/us in my/our own language. I/we confirm that I have understood the above study and had the

opportunity to ask questions. I/we understand that my participation in the study is voluntary and that I/we am free to withdraw at any time, without giving any reason, without the medical care that will normally be provided by the hospital being affected. I/we agree not to restrict the use of any data or results that arise from this study provided such a use is only for scientific purpose(s). I/we have been given an information sheet giving details of the study. I/we fully consent for detailed examination, investigations and to participate in the above study.

Signature of the participant/ next of kin: ______________________ Date: _____________

Signature of the witness ________________________ Date: _____________

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