BANGALORE.
ANNEXURE - II
PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION
1. / NAME OF THE CANDIDATE AND ADDRESS / Dr. ARUN B. S.
POST GRADUATE STUDENT,
DEPARTMENT OF GENERAL MEDICINE,
KARNATAKA INSTITUTE OF MEDICAL SCIENCES,
HUBLI- 580022.
2. / NAME OF THE INSTITUTION / KARNATAKA INSTITUTE OF MEDICAL SCIENCES,
HUBLI -580022
3. / COURSE OF THE STUDY AND SUBJECT / M.D. IN GENERAL MEDICINE
4. / DATE OF ADMISSION TO THE COURSE / 31 MAY 2013
5. / TITLE OF THE TOPIC / “STUDY OF PULMONARY HYPERTENSION IN PATIENTS WITH CHRONIC KIDNEY DISEASE”
6. / BREIF RESUME OF THE INTENDED WORK :
6.1 NEED FOR THE STUDY
Pulmonary Hypertension is a routinely made diagnosis in cardiology and pulmonary clinic. Pulmonary hypertension is defined as a mean pulmonary artery pressure more than or equal to 25 mm Hg or Pulmonary artery systolic pressure more than 35 mm Hg. Pulmonary hypertension is a recognized complication of chronic kidney disease, especially in end stage renal disease. It has prevalence estimates of 30-50%. Occurrence of pulmonary hypertension in patients on hemodialysis ranges from 27 to 58%. Pulmonary hypertension is an independent predictor of increased mortality in patients on dialysis and those undergoing kidney transplantation.1
The pathogenesis of pulmonary hypertension in CRF is not fully elucidated. It is most likely due to interaction of multiple aspects of altered cardiovascular physiology:
1. Increased cardiac output1
2. Myocardial dysfunction leading to elevated left heart filling pressure
3. Volume overload
4. Arteriovenous fistula
5. Exposure to dialysis membranes
6. Alteration in endothelial function due to hormonal and metabolic disorders in uraemia leading to pulmonary vasoconstriction and decreased compliance of pulmonary vasculature
7. Vascular calcification and stiffening
8. Severe anemia2
9. Thromboxane B2 and pro-BNP3
6.2 REVIEW OF LITERATURE:
There have been several studies conducted to study the association of pulmonary hypertension in patients with chronic kidney disease.
1. Bolignano D, Rastelli S, Agarval R et al studied pulmonary hypertension in CKD patients and concluded that pulmonary hypertension ranges from 9-39% in individuals with stage 5 CKD, 18.8%-68.8% in hemodialysis patients, and 0-42% in patients on peritoneal dialysis therapy.2
2. Mordechai yigla et al concluded 40% patients undergoing long term hemodialysis access via an arteriovenous access had pulmonary hypertension . They also showed that mortality among hemodialysis patients with pulmonary hypertension is higher(30.4%) than those without pulmonary hypertension4
3. A Cross-Sectional Italian Study by Fabio Fabbian et al showed that 39% of the patients on dialysis developed pulmonary hypertension. 18.5% of peritoneal dialysis and 58.6% of hemodialysis patients. They also concluded that it appears to be a late complication of hemodialysis treatment, mainly related to cardiac performance and cardiovascular disease history.5
4. Etemadi J et al showed that Pulmonary arterial hypertension was found in 41.1% of hemodialysis patients and 18.7% of peritoneal dialysis patients. They also showed hemoglobin and serum iron are lower in patients with pulmonary hypertension than in those with normal pulmonary artery systolic pressure.6
5. Study by L. Di Lullo et al showed a prevalence a 40% prevalence of pulmonary hypertension in chronic kidney disease patients on hemodialysis.7
6.3 OBJECTIVES OF STUDY:
1. To study the prevalence of pulmonary hypertension in patients with chronic kidney disease.
2. To assess severity of pulmonary hypertension in different stages of chronic kidney disease.
3. To study the impact of dialysis on pulmonary artery systolic pressure.
7. / MATERIALS AND METHODS
7.1 Source of data:
Patients with chronic kidney disease attending to outpatient department and admitted in medicine, nephrology and cardiology wards at Karnataka Institute of Medical Sciences, Hubli between 1st of January 2014 to 31st of December 2014
7.2: a) Methods of collections of data:
· Chronic kidney disease patients fulfilling the inclusion and exclusion criteria will be informed about aims and objectives of the study and informed consent will be taken.
· Information will be collected in preformed proforma from each patient.
· Pulmonary hypertension will be determined using doppler echocardiography. Patients will be followed up at 0, 2 and 4 months.
· The data will be analyzed by using appropriate statistical tests.
INCLUSION CRITERIA:
1. Diagnosed patients of chronic kidney diseases on hemodialysis
2. Newly diagnosed cases of chronic kidney disease
3. Age >18 years
EXCLUSION CRITERIA:
1.Those not willing for participating in the study
2.Age <18 years
3.Valvular heart diseases
4.Congenital heart diseases
5.Pulmonary obstructive and restrictive lung diseases
6.HIV infected patients
7.Chronic liver disease
8.Connective tissue diseases
9.Hypothyroidism and Hyperthyroidism
7.2 COLLECTION OF DATA:
The data was collected using a predesigned proforma used for all cases including detailed history and clinical examination findings, necessary laboratory investigations. Data related to kidney disease including etiology/risk factors of Chronic kidney disease, age of onset duration of hemodialysis therapy and AV fistula access location were recorded from the patient directly or from their hospital files.
SAMPLE SIZE:
A minimum of 100 patients with Chronic kidney disease fulfilling the inclusion and exclusion criteria attending KIMS hospital, Hubli.
7.3 DOES THE STUDY REQUIRE ANY INVESTIGATIONS OR INTERVENTIONS TO BE CONDUCTED ON PATIENTS, HUMANS OR ANIMALS? IF SO, PLEASE DESCRIBE BRIEFLY
YES. Study requires investigations on patients
Following investigations will be done:
1. Blood urea, serum creatinine, serum uric acid
2. Serum electrolytes
3. Urine routine- glucose, protein, microscopy
4. USG abdomen
5. GFR estimation
6. Complete hemogram
7. Chest X-ray P.A view
8. Liver function tests.
9. ECG
10.2D Echocardiography, Doppler Echocardiography
Following investigations will be done if clinically indicated:
1. Thyroid function test
2. X- ray spine and pelvis
3. CRP, RA factor, ANA
7.4 Has ethical clearance been obtained from your institution
Yes, clearance has been obtained from the Ethical Committee of Karnataka Institute of Medical Sciences, Hubli.
Statistical analysis:
Results will be analyzed by using appropriate statistical tests.
8. / LIST OF REFERENCES:
1. Andrew M, Meghan E, Richard N. Pulmonary hypertension in patients with chronic and end-stage kidney disease. Kidney International(2013)84,682–692
2. Bolignano D,Rastelli S,Agarwal R,Fliser D,Massy Z,Ortiz A,et al. Pulmonary hypertension in CKD. Am J Kidney Dis2013; 61(4):612-22.
3. Addelwhab S, Elshinnawy S. Pulmonary hypertension in chronic renal failure patients. Am J Kidney Dis 2008; 28(6) 900-997.
4. Yigla M, Nakhoul F, Sabag A, Tov N, Gorevich B, Abassi Z, et al. Pulmonary hypertension in patients with end-stage renal disease. Chest.2003; 123(5 ):1577-1582.
5. Fabbian F, Cantelli S, Molino C,Pala C,Longhini C,Portaluppi F. Pulmonary Hypertension in Dialysis Patients: A Cross-Sectional Italian Study. International Journal of Nephrology Volume2011, Article ID283475, 4 pages, 2011
6. Etemadi J,Zolfaghari H,Firoozi R,Ardalan MR,Toufan M,Shoja MM,et al. Unexplained pulmonary hypertension in peritoneal dialysis and hemodialysis patients. Rev Port Pneumol.2012 Jan-Feb;18(1):10-14.
7. Di Lullo L,Floccari F,Rivera R,Barbera V, Granata A, Otranto G et al. Pulmonary Hypertension and Right Heart Failure in Chronic Kidney Disease: New Challenge for 21st-Century Cardionephrologists. Cardiorenal Med.2013 July;3(2): 96–103.
9. / SIGNATURE OF THE CANDIDATE
10. / REMARKS OF THE GUIDE / RECOMMENDED AND FORWARDED
REMARKS OF THE CO-GUIDE / RECOMMENDED AND FORWARDED
11. / 11.1 NAME AND DESIGNATION
OF THE GUIDE / Dr.Suresh H. M.D., D.M.(CARDIOLOGY) Associate professor, department OF GENERAL MEDICINE,
KIMS, HUBLI.
11.2 SIGNATURE
11.3 NAME AND DESIGNATION
OF THE CO-GUIDE / Dr.Venkatesh moger. M.D., D.M.(nEPHRO) Associate professor,
department OF NEPHROLOGY,
KIMS, HUBLI.
11.4 SIGNATURE
11.5 HEAD OF THE DEPARTMENT / Dr. h. mallikarjun swamy M.D.
PROFESSOR & HEAD,
DEPARTMENT OF General medicine
KIMS, HUBLI.
11.6 SIGNATURE
12. / 12.1 REMARKS OF THE CHAIRMAN AND THE PRINCIPAL
12.2 SIGNATURE.
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