SYNOPSIS OF

DISSERTATION

Dr. Guru Prasad.BDEPT OF GENERAL MEDICINE.

SREE SIDDHARTHA MEDICAL COLLEGEAGALAKOTE, TUMKUR

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RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

ANNEXURE II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

1 NAME AND ADDRESS OF THE CANDIDATE

DR. GURU PRASAD. BPOST GRADUATE IN GENERAL MEDICINEDEPARTMENT OF GENERAL MEDICINE SREE SIDDHARTHA MEDICAL COLLEGE B.H. ROAD, AGALAKOTE, TUMKUR-7KARNATAKA

2 NAME OF THE INSTITUTION SREE SIDDHARTHA MEDICAL COLLEGE AND RESEARCH CENTRE, TUMKUR, KARNATAKA

3 COURSE OF STUDY AND SUBJECT

MD GENERAL MEDICINE.

4 DATE OF ADMISSION 13-06-2008

5 TITLE OF THE TOPIC“A Clinical study of hepatorenal and

haematological profile in Malaria ”

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6. Brief resume of the intended work :

6.1 NEED FOR THE STUDY

Malaria is one of the major public health problems of the country.

Tumkur is one of the malarious districts of Karnataka. The bulk of malaria cases are generated in an area where boundaries of four districts meet. These districts, with high risk Primary Health Centres(PHC) are Chikmangalur (PHC Kadur), Chitradurga (PHC Hosdurga), Hassan (PHC Arsikere) and Tumkur (PHC Chikanayakanhalli).(4)

In Tumkur district, 4 Talukas constitute high risk and problem areas. These are (a) Sira, Chikkanayaakanalli, (b) part of Tiptur, (c) Kyathsandra of Tumkur, and (d) part of Gubbi. Anaphelus culicifacies (species A) and Anaphelus fluviatilis (species S) are the two malaria vectors of malaria. The major vector breeding sites are: 4 dams, 26 712 tanks, 16 943 wells, 55 852 bore wells and rain water collection sites.(4)

In Tumkur, about 3 000 malaria cases are reported annually; of which 15-20% constitute Plasmodium falciparum. Malaria API in the district ranged between 2.2 to 5.4 in the last five years. There are two general hospitals (500 beds each), 7 Taluk hospitals (50 beds each) and 28 Ayurvedic hospitals.(4) In manifestation of severe Plasmodium Falciparum Malaria the signs may include severe normocytic, normochromic anemia, renal failure, cerebral malaria, acidosis, acute respiratory distress syndrome, hypoglycaemia, jaundice, hyperparasitemia, disseminated intravascular coagulation(DIC), haemoglobinuria convulsions and shock.(1)

The hepatorenal parameters indicating poor prognosis in severe malaria are elevated serum creatinine >3 mg/dl, total bilirubin > 3mg/dl, elevated liver enzymes (aspartate transaminase/ alanine transaminase >3 times upper limit of normal). Malaria affects kidneys leading to both tubulointerstitial damage as well as glomerulonephritis. Acute renal failure due to acute tubular necrosis occurs in falciparum malaria. Glomerulonephritis in malaria is due to plasmodium malariae (7). Though nephrotic syndrome is commonly associated with Plasmodium malaria it can also be seen with other malarial species. Renal impairment is common with adults with severe Plasmodium falciparum malaria, most commonly presents as acute renal failure.(1) Hepatic involvement commonly presents as jaundice which can be due to intravascular haemolysis of the red blood cells(RBC), DIC, microangiopathic haemolysis and malarial hepatitis.(6)

The haematogical parameters indicating poor prognosis are leucocyte count > 12,000/microl, severe anemia (Haemoglobin < 5gm/dl) and coagulopathy (1).Common hematological abnormalities seen are anemia, thrombocytopenia with coagulopathy. Pancytopenia reflects hypersplenic state in malaria due to increased peripheral destruction of all cell lineages.(5)

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Since Tumkur is an endemic area and due to continually escalating malaria cases in our locality, it is ideal for a study to be conducted here, to know the hepatorenal and hematological profile, and hence the degree of complication that can arise from these deranged parameters .No study has been undertaken in this area involving all the three parameters. Hence this study is being undertaken.

6.2 REVIEW OF LITERATURE.

Malaria is the most important protozoal parasitic disease of humans

affecting more than 1 billion people world wide and causing 1-3 million death each year. (1)The word malaria derives its origin from the Italian “mal-aria” meaning bad air.(2)

Charles Louis Alphonse Laveran, a French army surgeon stationed in Constantine, Algeria, was the first to notice parasites in the blood of a patient suffering from malaria on the 6th of November 1880. For his discovery, Laveran was awarded the Nobel Prize in 1907.On August 20th, 1897, Ronald Ross as the first to demonstrate that malaria parasites could be transmitted from infected patients to mosquitoes.(2)

In India, formal malaria control programmes were started under British colonial rule and continued after Indian Independence in 1948. Early malaria control efforts involved removal of breeding sites and later used chemicals such as the larvicides Paris green and kerosene. In 1946, pilot schemes using DDT were set up in several areas, including Karnataka. Usefulness of DDT prompted the launch of the National Malaria Control Programme (NMCP) in 1953. The programme saw tremendous impact and the annual number of cases came down to 49151 by 1961, with a belief that malaria could be eradicated in seven to nine years. On the contrary, malaria began to re-emerge in 1965. With increase in malaria cases in urban areas, The Urban Malaria Scheme (UMS) was launched in 1971. In 1977 the Modified Plan of Operation (MPO) was launched. The National Anti Malaria Programme (NAMP) was launched in 1995. In 2004, the integrated National Vector Borne Disease Control Programme (NVBDCP) for the prevention and control of vector borne diseases was launched. Despite all these measures malaria still prevails causing significant morbidity and mortality.(3)

Causes of anemia in malaria are- hemolysis of infected RBC’s, hemolysis of

non infected RBC’s [black water fever],dyserthryopoesis, splenomegaly and folate depletion.(7)

Renal dysfunction can also arise due to hemoglobinuria [black water fever] , oliguria and anuria due to acute tubular necrosis.(7)Nephrotic syndrome is seen in plasmodium malariae infection.(7) Plasmodium malariae infection is prevalent in tumkur.(3) Renal dysfunction usually resolves , urine flow resumes in a median of 4 days and serum urea creatinine returns to normal in a mean of 17 days.(1)

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Hepatic involvement manifests commonly as mild hemolytic jaundice. Severe jaundice can be seen due to hemolysis, hepatocyte injury and cholestasis .When compared to other vital organ dysfunction, liver dysfunction carries a poor prognosis.(1)Another study has also shown that liver involvement has poor outcome.(6)

Hence this study is conducted to study the derangement in biochemical parameters and its correlation with outcome of disease.

6.3 OBJECTIVES OF THE STUDY

To study the clinical and biochemical profile of hepatic, renal and hematological

dysfunction in patients with malaria and correlate its implication in course of disease in

hospitalized patients of SREE SIDDHARTHA MEDICAL COLLEGE ,TUMKUR.

7. Material and methods

7.1 SOURCE OF DATA

Confirmed cases of Malaria admitted in wards at Sree Siddhartha Medical

College Hospital and Research Centre, Tumkur. 100 clinically and Microscopy

proven cases of Malaria would be studied over a period of one and half years.

7.2 METHOD OF COLLECTION OF DATA A case study of patients with malaria irrespective of species, to delineate the clinical and

biochemical characters of hepatic, renal and hematological involvement which involves-

detailed history followed by clinical examination

Malaria patients will be investigated by doing complete haemogram ,

blood urea , serum creatinine, liver function tests and ultrasound abdomen.

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INCLUSION CRITERIA.

Clinically and Microscopy proven cases of malaria admitted to medical ward.

EXCLUSION CRITERIA.

1. Cases with abnormal liver function tests with positive viral markers, cirrhosis

and hepatotoxic drug use.

2. Known case of acute/chronic renal failure due to any other cause.

3. Bleeding diathesis

Study period : one and half year.

Statistics used : Non-parametric tests will be used to analyze the data.

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PROFORMA

Name IP no

Age/sex D.O.A

Address D.O.D

CHIEF COMPLAINTS

History Of Presenting Illness :

A. Fever: Duration

Type: continuous / remittent / intermittent.

Degree: mild / moderate / severe

Associated symptoms: sweating / others

B. Chills/ rigors

C. Bodyache / fatigue / nausea / vomiting

D. Headache: Site / duration / nature.

E. Loose stools

F. Pain abdomen: Duration / site / nature / radiation / aggravating and

relieving factors

G. Cough: Productive / non productive

H. Breathlessness

I. Altered sensorium

J. Convulsions: Duration / nature / generalized / focal

K. Bleeding manifestation

L. Jaundice

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M. Itching

N. Oliguria

O. Petechiae.

P. Others

Past history

Similar complaints, diabetes mellitus, hypertension, jaundice,

epilepsy

Family history

Personal history

Menstrual history

EXAMINATION

General Physical Examination

Pulse, temperature, Blood Pressure, Respiratory Rate.

Pallor, Cyanosis, Clubbing, Icterus, Lymphadenopathy,Rashes,Edema

Abdominal examination

Inspection

Palpation –

Liver/Spleen:

Palpable by --------- cms below costal margin / not palpable

Tenderness: present/ absent

Percussion:

Auscultation:

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Respiratory system

Cardiovascular system

Central nervous system

Higher motor function

Cranial nerves

Motor system

Sensory system

Meningeal signs

Investigations

Smear for Malarial Parasite: parasites present / absent.

Plasmodium vivax/ falciparum

MP( QBC ): Positive / negative

Complete haemogram

Hemoglobin, total leukocyte count, differential leukocyte count, erythrocyte sedimentation rate, mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, mean corpuscular volume, packed cell volume, reticulocyte count, platelet count, peripheral smear, prothrombin time, bleeding time, clotting time.

Liver function tests

Total bilirubin( direct and indirect), alanine transaminase, aspartate transaminase, alkaline phosphatase, Total protein, serum albumin, serum globulin.

Renal function tests

blood urea, serum creatinine, urine routine.

Others – ultrasound abdomen

Cerebrospinal fluid analysis

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7.3 Does the study require any investigations or interventions to be

conducted on patients.

YES

1. Complete haemogram,

2. Peripheral smear for malaria, MP(QBC)

3 Blood urea, Serum creatinine, urine routine.

4. Liver Function Tests.

5. Ultrasound Abdomen.

7.4 Has ethical clearance been obtained from your institution in case of 7.3?

YES

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8. List of References:

1. White NJ, Breman JG. Malaria. In: Fauci AS, Braunwald E, Kasper DL, Hauser

SL, Longo DL, Jameson JL et al, editors. Harrison’s principles of internal

medicine. 17th ed. New York: Mc Graw hill; 2008. p. 1280-94.

2. White NJ. Malaria. In: Cook GC, Zumla A, editors. Manson’s tropical disease.

21st ed. London: Sounders; 2003. p. 1205-95.

3. Park K, editor. Malaria. In: Park’s textbook of preventive and social medicine.

19th ed. Jabalpur: Banarsidas bhanot; 2007. p. 209-20.

4. WHO(2007) Malaria, situation analysis of selected districts in south east asia

countries for roll back malaria. [Online]. 2007 Jan 9; Available from:

URL:http://www.searo.who.int/en/section10/section21/section340_4029.htm

5. Jandl JH, editor. Haemolytic anaemia caused by infection of red cell. In: Blood:

Textbook of haematology. 2nd ed. Boston: Little, Brown and company; 1996. p.

482-4.

6. Das SN, Mohapatra.B, Mohanty R, Dash PC, Kar K, Dash PK. Malarial hepatitis

as a component of multiorgan failure – A bad prognostic sign. JIMA 2007

may;105(5):246-50.

7. Kumar P, Clark M, editors. Malaria. In: Kumar and Clark clinical medicine. 5th

ed. Edinburgh:WB Saunders; 2002. p. 98-102.

9. Signature of Candidate

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10. Remarks of the guide Malaria is a common infectious disease in Tumkur. Varied complications are seen but hepatorenal and haematalogical complications are more dangerous. Hence this study is selected.

11. Name and Designation of( in Block Letters)

11.1 Guide Dr. R. MUDDARANGAPPA.PROFESSOR DEPARTMENT OF GENERAL MEDICINESREE SIDDHARTHA MEDICAL COLLEGE, TUMKUR

11.2 Signature

11.3 Head of Department Dr. SHARATH KUMAR.D.SHAHPROFESSOR AND HODDEPARTMENT OF GENERAL MEDICINESREE SIDDHARTHA MEDICAL COLLEGE, TUMKUR

11.4 Signature

12. 12.1 Remarks of the Chairman and Principal

12.2 Signature

Sree Siddhartha Medical CollegeAgalkote, B H road, Tumkur-572107.

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(Recognised by Medical Council of India & Affiliated to Bangalore University/R.G.U.H.S)

Ph:0816-278867 Fax:0816-2752110 email: SSMC_tmk@hotmail.com

___________________________________________________________________________

Ref No SSMC/PRI/ /2008-2009

TO,

The Registrar.

R.G.U.H.S.

Jayanagar, 4th block,

Bangalore-560011.

KARNATAKA.

Respected Sir,

SUB: : Institutional Ethical Clearance

…………

With regard to subject mentioned above, the dissertation

subject titled

“A clinical study of Hepatorenal and haematological profile in malaria” is justifiable & has taken ethical clearance from the

Institution.

Thanking you,

Yours Faithfully.

Principal

SREE SIDDHARTHA MEDICAL

COLLEGE,

TUMKUR.

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Sree Siddhartha Medical CollegeAgalkote, B H road, Tumkur-572107.

(Recognised by Medical Council of India & Affiliated to Bangalore

University/R.G.U.H.S)

Ph:0816-278867 Fax:0816-2752110 email: SSMC_tmk@hotmail.com

__________________________________________________________________

_________

Ref No SSMC/PRI/ /2008-2009

TO,

THE CHAIRMAN,

ETHICAL CLEARANCE COMMITTEE

SREE SIDDHARTHA MEDICAL COLLEGE

AGALAKOTE, TUMKUR

Respected Sir,

SUBJECT: Institutional Ethical Clearance.

With respect to above mentioned subject, I, Dr GURU

PRASAD. B want to bring to your notice that I am post graduate student in the

department of medicine wanting to do my dissertation on the topic “A clinical study of Hepatorenal and haematological profile in malaria”. I therefore request you Sir, to grant me ethical committee

clearance for my dissertation. Please oblige.

Thanking you,

Yours sincerely,

Dr. Guru Prasad.

B

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Sree Siddhartha Medical CollegeAgalkote, B H road,Tumkur-572107.

( Recognised by Medical Council of India & Affiliated to Bangalore

University/R.G.U.H.S)

Ph:0816-278867 Fax:0816-2752110 email: SSMC_tmk@hotmail.com

_______________________________________________________________________

INFORMED CONSENT FORM

I have explained to _________________________________ (patient/relevant

guardian), the purpose of this research, investigations and procedures

required, the possible risks & complications

involved.

Investigator: Dr GURU PRASAD B Date:

I have been explained by _____________________( name of the

investigator) the purpose to this research, the study procedure I will undergo

and the possible risks, complications or discomforts as well as benefits I may

experience, Alternatives to my participation in the study have also been

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discussed.

I have been explained all the above details in my own language and I

understand the same.

Therefore I agree to give my consent to participate as a subject in this research project.

S OF THIS PROCEDURE

Name _____________________ Signature of the patient/_____________

Relevant guardian Relevant guardian

Date ______________ Time ____________Date ______________ Time ____________

Name _____________________ Signature of the impartial witness _________

Date ______________ Time ____________Date ______________ Time ____________

Name _____________________ Signature of the Investigator _____________

Date ______________ Time ____________Date ______________ Time ____________

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