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 | |
| | | |
| | |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) | |
| | | | |
| |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 | |
| | | | |
|12 |12.1 |Remarks of the Chairman and Principal | |
| | | | |
| |12.2 |Signature | |
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