RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA



RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES, KARNATAKA

BANGALORE

ANNEXURE – II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR DISSERTATION

|1 |Name of the candidate and address ( in block |: |Dr. MANASA.A.S.GOWDA |

| |letters) | |DEPARTMENT OF MEDICINE |

| | | |MAHADEVAPPA RAMPURE MEDICAL COLLEGE, GULBARGA – 585105 |

| |Permanent address |: |Dr. MANASA.A.S.GOWDA |

| | | |#2, SANTHOSH VIHAR PHASE 1, JAKKUR MAIN ROAD, BYATARAYANAPURA. |

| | | |BANGALORE 560092. |

|2 |Name of the institution |: |H.K.E. SOCIETY’S MAHADEVAPPA |

| | | |RAMPURE MEDICAL COLLEGE, |

| | | |GULBARGA – 585105 |

|3 |Course of study and subjects |: |m.d.(General Medicine) |

|4 |Date of admission to the course |: | 31st May 2010 |

|5 |Title of Topic |: |EVALUATION OF THYROID FUNCTION STATUS IN PATIENTS WITH CHRONIC KIDNEY DISEASE. |

|6 |Brief Resume of the intended work |

| |6.1 |Need for the study |

| | | |

| | |Chronic kidney disease (CKD) is a worldwide health problem with an increasing incidence and prevalence, poor outcomes and high |

| | |cost. Abnormalities in the structure and function of the thyroid gland and in the metabolism and plasma concentration of thyroid |

| | |hormones are common in patients with CKD1,2 |

| | | |

| | |Various studies of thyroid functions in uremic patients have been carried out which have shown conflicting results , in view of |

| | |variability of Thyroid Function Tests in patients with CKD with previous studies , a prospective study of various thyroid functions|

| | |is undertaken to establish a correlation if any between thyroid dysfunction and severity of renal diseases. |

| |6.2 |Review of Literature |

| | |Chronic Kidney Disease(CKD) is defined as per The kidney disease outcomes quality initiative ,2003, [K/DOQI] of the National|

| | |Kidney Foundation [NFK] as either kidney damage or a decreased kidney glomerular filtration rate of less than |

| | |60ml/min/1.73m2 for 3 or more months (chronic renal failure corresponds to CKD stages 3-5).1,2,3 |

| | | |

| | |P Iglesias and J J Diez in the year 2009, showed that in their study, thyroid hormone especially T3 can be considered as a |

| | |marker for survival in patients with kidney disease, serum TSH concentration is usually normal or elevated in CKD, free and |

| | |total T3 and T4 concentrations are usually normal or low in patients with CKD. CKD is associated with higher prevalence of |

| | |primary hypothyroidism , both overt and subclinical but not with hyperthyroidism.4 |

| | | |

| | |Sang Heon Song , Ihm Soo Kwak , Dong Won Lee in the year 2009, showed that in their study, low T3 syndrome was highly |

| | |prevalent in CKD and was a remarkable finding in early CKD , furthermore, serum T3 levels were associated with severity of |

| | |CKD even in the normal TSH level.5 |

| | | |

| | |Michel Chonchol,Giuseppe Lippi, Gianluca Salvagno in the year 2008, showed that in their study subclinical primary |

| | |hypothyroidism is a relatively common condition in approximately 18% among persons with CKD not requiring chronic dialysis |

| | |and it is independently associated with progressively lower estimated glomerular filtration rate in a large cohort of |

| | |unselected outpatient adults.6 |

| | | |

| | |Pon Ajil Singh, Zachariah Bobby, N Selvaraj in the year 2006, showed that in 20 undialysed CRF patients serum T3 |

| | |concentration was less than normal range in 12 of the 20 patients with CRF (60%), serum T4 concentration was diminished |

| | |below the normal range in 15 patients (75%) with CRF , serum mean TSH concentration was within the normal range in CRF and |

| | |did not differ from that found in the control.7 |

| | | |

| | |G Avasthi, S Malhotra, APS Narang in the year 2001, showed that out of 30 patients with chronic renal sufficiency two |

| | |patients had clinical hypothyroidism with low serum T3, T4, FT4 and high serum TSH. Four patients had clinical goitre but |

| | |were euthyroid.The remaining 24 patients did not have goitre and they were clinically euthyroid. The mean values of serum |

| | |T3, T4 and FT4 were significantly lower and mean serum TSH was significantly higher as compared to controls. To conclude |

| | |thyroid dysfunction occurs both clinically and biochemically in patients with chronic renal insufficiency.8 |

| | | |

| | |Joseph L J, Hardy M J in the year 1993 and 1988 respectively revealed that low T3 and T4 levels and high TSH level |

| | |suggesting maintenance of pituitary axis in patients with CKD.9,10 |

| | | |

| | |Mehta HJ, Joseph LJ, Desai KB in the year 1991 showed that out of 127 patients in whom levels of serum T3,T4,FT3,FT4 and TSH|

| | |were measured 93 patients belonging to group 1 on conservative management showed significant reduction in T3 , T4 and FT4 |

| | |levels in comparison with those in normal subjects.However TSH and FT4 levels did not show significant alterations. The |

| | |remaining 34 patients belonging to group 2 on regular dialysis therapy showed similar values as in group 1 except for a |

| | |decrease in TSH levels as compared to normals.11 |

| | | |

| | |Kaptein, in the year 1988 estimated the prevalence of primary hypothyroidism was about 2.5 times much frequent in chronic |

| | |renal failure and dialysis. The hypothyroidism in CRF was estimated to range between 0 and 9.5%. Kaptein study also |

| | |estimated the presence of anti thyroid antibody titre in 6.7% of CRF.12 |

| | | |

| | |Quion Verde in the year 1984 reported high prevalence of hypothyroidism in chronic renal failure. It was estimated to be |

| | |about 5% in patients with terminal renal failure.13 |

| | | |

| | |German Ramirez, William O Neill, William Jubiz in the year 1976 found that in patients with chronic renal failure not on |

| | |dialysis have mean serum thyroxine levels similar to normal subjects and low mean T3 levels. However both T4 and T3 |

| | |concentrations decreased as the renal function worsens.14 |

| | | |

| | |David A Spector, Paul J James, J Harold Helderman in the year 1976 found that out of 38 patients with chronic renal |

| | |insuffiency 43% had low serum T3 and 54% had low serum FT3 concentrations. TSH concentration was normal in all but four |

| | |patients who had very slight elevations. Low serum T3 measurements did not accurately reflect metabolic state in patients |

| | |with CRF, whereas serum FT4 and TSH concentrations were reliable indicators of thyroid state.15 |

| |6.3 |Objectives of the study |

| | |To study the prevalence of thyroid dysfunction in patients with chronic kidney disease. |

| | |To study the correlation between thyroid dysfunction and severity of renal diseases. |

| | |To differentiate primary thyroid diseases from thyroid dysfunction due to chronic kidney disease. |

|7 |Materials and methods |

| |7.1 |Source of data |

| | |Patients with chronic kidney disease admitted in Basaveshwar Teaching and General Hospital, Gulbarga attached to |

| | |Mahadevappa Rampure Medical College. |

| | | |

| |7.2 |Methods of collection of data ( including sampling procedure, if any) |

| | | |

| | |Study Subjects: |

| | |The present study is conducted on 50 patients of, who are diagnosed to have chronic kidney disease and being admitted in|

| | |Basaveshwar teaching and general hospital, Gulbarga during the period of January 2011 to June 2012. |

| | | |

| | |Inclusion criteria: |

| | | |

| | |Patients with chronic kidney disease. |

| | | |

| | |Patients who fulfil the criteria for CKD and who are on conservative management. |

| | | |

| | |Criteria for CKD in failure: |

| | | |

| | |Symptoms of uraemia for 3 months or more |

| | |Elevated blood urea, serum creatinine and decreased creatinine clearance. |

| | |Ultra sound evidence of chronic renal failure, |

| | |Bilateral contracted kidneys – size less than 8 cm in male and size less than 7 cm in female |

| | |Poor corticomedullary differentiation |

| | |Type 2 or 3 renal parenchymal changes |

| | |Supportive laboratory evidence of CRF like anemia, low specific gravity, changes in serum electrolytes, etc. |

| | |Radiological evidence of renal osteodystrophy |

| | | |

| | |Exclusion criteria: |

| | | |

| | |Patients undergoing peritoneal dialysis or haemodialysis |

| | |Nephrogenic range of proteinuria |

| | |Low serum protein especially albumin |

| | |Other conditions like, |

| | |Acute illness |

| | |Recent surgery, trauma or burns |

| | |Diabetes mellitus |

| | |Liver diseases |

| | |Drugs altering thyroid profile like amiodarone, steroids, dopamine, phenytoin, beta-blocker, estrogen pills, |

| | |iodine-containing drugs. |

| | | |

| | |Details of clinical history and clinical examination are undertaken with preference to thyroid and renal diseases. |

| |7.3 |Does the study require any investigation or intervention to be conducted on patients or other humans or animals? if so |

| | |please describe briefly |

| | | The following investigations are performed: |

| | | |

| | |Urine routine and microscopic examination |

| | |Peripheral smear for anemia and burr cells |

| | |Blood urea,serum creatinine and creatinine clearance(using Cockroft-Gault formula) |

| | |Serum electrolytes including calcium and phosphorous |

| | |Serum cholesterol |

| | |24 hour urine protein and serum protein |

| | |ECG, chest X ray and 2D Echo. |

| | |X ray wrist, forearm and spine for evidence of renal osteodystrophy |

| | |Ultrasound abdomen for CRF |

| | |FNAC in patients presenting with thyroid swelling |

| | |After selecting patients fulfilling the above criteria blood sample is collected in non heparinised serum bottle and |

| | |sent for thyroid profile [serum triiodothyronine(T3),serum thyroxine(T4) and serum thyroid stimulating hormone (TSH). |

| | | |

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

| | | |

| | |Yes. Ethical clearance has been obtained from “Ethical clearance committee” of the institution. |

|8 |List of References |

| |Andrew S. Levey, Josef Coresh, Ethan Balk, Annamaria T. Kausz, Ronald D. Perrone.National Kidney Foundation Practice Guidelines |

| |for Chronic KidneyDisease: Evaluation, Classification, and Stratification. MD Ann Intern Med. 2003;139:137-147. |

| |Robert W Schrier .Abnormalities in the thyroid gland and hypothalamo pituitary thyroid axis in patients with CKD – Diseases of the |

| |kidney and urinary tract .eighth edition 2007; volume 3: page number 2518. |

| |Harrison’s principles of internal medicine 17th edition, 2008; vol 2: page numbers 1761-1762. |

| |P Iglesias and J J Di´Ez .Thyroid dysfunction and kidney disease .European Journal of Endocrinology (2009) 160: 503–515 |

| |Sang Heon Song, IhmSoo Kwak, Dong Won Lee, Yang Ho Kang, Eun Young Seong and Jin Sup Park. The prevalence of low triiodothyronine |

| |according to the stage of chronic kidney disease in subjects with a normal thyroid-stimulating hormone . Nephrol Dial Transplant |

| |(2009) 24: 1534–1538. |

| |Michel Chonchol, Giuseppe Lippi, Gianluca Salvagno, Giacomo Zoppini,Michele Muggeo, and Giovanni Targher .Prevalence of Subclinical |

| |Hypothyroidism in Patients with Chronic Kidney Disease. Clin J Am Soc Nephrol 2008; 3: 1296–1300. |

| |Pon ajil singh, Zachariah bobby, N. Selvaraj and R. Vinayagamoorthi. An evaluation of thyroid hormone status and oxidative stress in|

| |undialyzed chronic renal failure patients.Indian j physiol pharmacol2006; 50 (3) : 279–284. |

| |G Avasthi, S Malhotra, APS Narang, S Sengupta .Study of thyroid function in patients of chronic renal failure. Indian J Nephrol |

| |2001;11: 165-169. |

| |Joseph L.J. et al.Measurement of serum thyrotropin levels using sensitive immunoradiometric assays in patients with chronic renal |

| |failure, alterations suggesting an intact pituitary thyroid axis. Thyroidology.1993; 5:35- 9. |

| |Mehta HJ, joseph LJ, Desai KB, Mehta MN, Samuel AM, Almeida AF, Acharya VN. Total and free Thyroid hormone levels in chronic renal |

| |failure. J post grad med 1991;37:79-83. |

| |Hardy MJ et al. Pituitary – Thyroid function in chronic renal failure assessed by a highly sensitive thyrotropin assay. J clin |

| |Endocrinol metab.1988; 66:233 – 6. |

| |Kaptein E et al. The Thyroid in end stage renal diseases,Medicine. 1988; 67:187 – 97. |

| |Quion-verde et al. Prevalence of thyroid disease in chronic renal failure and dialysis patients. IXth Int Congr of Nephrol. 1988; |

| |120. |

| |German Ramirez ,William o’Neill,jr,William Jubiz and H.Allan Bloomer .Thyroid Dysfunction in Uremia : evidence for thyroid and |

| |hypophyseal abnormalities.Ann Inter med 1976; 84:672 –6 |

| |David Spector,Paul J Davis ,J Harold Helderman,Barbara Bell and Robert D Utiger . Thyroid function and metabolic state in chronic |

| |renal failure.Ann Intern Med.1976; 85:724 – 30. |

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|9 |Signature of Candidate | |

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| | |This is a unique study in our area which will help to know the thyroid|

|10 |Remarks of guide |abnormalities in patients with chronic kidney disease. |

| | | |Dr. G. VEERANNA |

|11 |11.1 |Name and designation of the Guide |M.D., D.M(Cardiology) |

| | | |PROFESSOR AND HOD |

| | | |DEPARTMENT OF MEDICINE |

| | | |M.R.MEDICAL COLLEGE, GULBARGA |

| | | | |

| |11.2 |Signature | |

| | | | |

| |11.3 |Co- guide (if any) | |

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| |11.4 |Signature | |

| | | | |

| |11.5 |Head of the Department |Dr. G.VEERANNA |

| | | |M.D.,D.M(Cardiology) |

| | | |PROFESSOR AND HOD |

| | | |DEPARTMENT OF MEDICINE |

| | | |M.R.MEDICAL COLLEGE, GULBARGA |

| | | | |

| |11.6 |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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