RAJIV GANDHI UNIVERSITY OF HEALTH SCIENCES,

BANGALORE, KARNATAKA.

ANNEXURE –II

PROFORMA FOR REGISTRATION OF SUBJECTS FOR

DISSERTATION

1 / Name of the Candidate
and address
(In block letters) / : / DR.SARAYU SANKEPALLY
POST GRADUATE STUDENT,
DEPARTMENT OF GENERAL MEDICINE,
NAVODAYA MEDICAL COLLEGE,
HOSPITAL & RESEARCH CENTRE,
RAICHUR-584103.
2 / Name of the Institution / : / NAVODAYA MEDICAL COLLEGE,
HOSPITAL & RESEARCH CENTRE,
RAICHUR-584103.
3 / Course of study and subject / : / M.D GENERAL MEDICINE(3Years)
4 / Date of admission to the course / : / 12th JUNE 2013
5 / Title of the Topic
“STUDY OF CLINICO-AETIOLOGICAL PROFILE OF HYPONATREMIA IN
HOSPITALISED PATIENTS IN NAVODAYA
MEDICAL COLLEGE HOSPITAL RESEARCH CENTER, RAICHUR”
6 / Brief Resume of the Intended Work
6.1 / Need of the study :
Disorder of sodium and water metabolism is common in hospitalized patients and is occasionally encountered in outpatients. Both hyponatremia and hypernatremia can cause morbidity and mortality and ironically incorrect treatment can end into the problem.
Normal serum sodium levels are 135-145meq/L.Hyponatremia is defined as the serum sodium concentration of <135meq/L. This disorder is almost always the result of an increase in circulating AVP and/or increased renal sensitivity to AVP combined with any intake of free water, a notable exception being low salt intake.1 The clinical representation has the wide spectrum, varying from asymptomatic patients to ones having seizures and coma. Patients with clinically significant hyponatremia present with non-specific or neurological symptoms attributable to cerebral edema, when coupled with recent history of altered fluid balance, these symptoms suggest the possibility of hyponatremia.This can cause substantial morbidity and mortality.2
Studies suggest that hyponatremia may be present in 15% to 22% patient in chronic care facilities.3 The incidence is much more in the elderly owing to the impaired ability to maintain the electrolyte homeostasis due to following reasons:
1.  By the age of 75 to 80 yrs the total body water content will decline to 50% and even more of decline in elderly women.4
2.  Thirst mechanism and maximal urinary concentrating ability decrease with age and increase the risk of dehydration.5,6
3.  ADH release is not impaired with aging but the levels are increased for a given plasma osmolality level ,indicating a failure of normal responsiveness of the kidney to ADH.7
4.  The renal anatomical and physiological changes which alter the water balance in elderly are decreased renal mass,cortical blood flow and glomerular filtration rate and as well as impaired responsiveness to sodium balance. Elderly patient have a diminished reserve of water balance and impaired regulatory mechanisms.7,8,9
Thus study is done to know the incidence, clinical profile and aetiology of hyponatremia in patients and to correlate the outcome of these patients with serum sodium levels at the time of admission.
6.2 / Review of Literature:
Rao et al, in a hospital based descriptive study of symptomatic hyponatremia in elderly patients conducted on 100 patients with symptomatic hyponatremia, they concluded hyponatremia is more common in females and they tend to tolerate it better than their male counterparts. Lethargy, drowsiness with slow response and irrelevant talk were concluded as most common symptoms.According to the study 61% were euvolemic, 23% were overloaded and 16% dehydrated. Commonest type was concluded as isovolemic hyponatremia. The common causes of hyponatremia were SIADH[30%] followed by drugs[25%].2
In a study done on frequency and etiology of hyponatremia in adult hospitalized patients in medical wards of a general hospital by Thomas Vurgese et al., commonest cause of hyponatremia was concluded as SIADH due to pneumonia.In the study conducted the overall incidence of hyponatremia was 3.6%. Out of these 56% were males and 44% were females. The commonest age group affected was 45-64 years. The mean serum sodium levels were 122 mmol/litre. About 59.1% patients presented during earlier summer months as compared to 40.9% who presented during winter months.3
Chua M et al., studied on prognostic implications of hyponatremia in elderly patients and concluded that drop in sodium during admission was strongly associated with increased length of stay and loss of independence.There were 103 cases ( mean age 82, 59% females ) , of whom 18% were hyponatremic on admission, but another 23% became hyponatremic while in hospital. Median length of stay was 13 days. Among the study population 65% cases were cured and 8% died. Factors independently associated with longer length of stay were increasing age, and larger drop in serum sodium during admission. Only a larger drop in serum sodium was significantly associated with failure to return to normal.10
Rahil .A.I et al. in their study they concluded that hyponatremia due to extra-renal loss was the most frequent cause of hyponatremia in our study; it was more prevalent among elderly patients than in younger patients. No significant gender related differences were found in the relative frequency rates. Moreover, no significant differences were found between moderate and severe hyponatremia with respect to consciousness impairment.11
Mahavir Agarwal et al., in a comparative study of the clinico-etiological profile of hyponatremia at presentation with, that developing in hospital, common symptoms were concluded as confusion [41%], headache [40%] and malaise [38.6%]. Decreased intake [82.9%] followed by increased loss of water [65.7%] was concluded as the most common causes of hyponatremia.Among the study group 31.4% developed hyponatremia during their stay in the hospital. Drugs, fluid overload and inappropriate ryles tube feeding are most common causes which precipitated hyponatremia in hospitalised patients.12
Nandini Chatterjee et al., in their study, the incidence of hyponatremia in their series was higher than values mostly reported in western literature. Euvolemic hyponatremia was the most common type, significant fraction of which was SIADH.13
Miyashita J et al., in a study on impact of hyponatremia and SIADH on mortality in elderly patients with aspiration pneumonia, concluded that hyponatremia due to SIADH was strongly associated with increased mortality in elderly patients. According to the study 29% of 221 patients had hyponatremia, of these 95% had hypotonic hyponatremia, which were further assessed as having hypovolemic [63%], hypervolemic [5%] and euvolemic [32%] hyponatremia. Of the euvolemic patients 70% had SIADH. Both moderate and severe hypotonic hyponatremia were significantly associated with increased in- hospital mortality. Hyponatremia due to SIADH was significantly associated with increased 30 day mortality.14
Rubio Rivas H et al. conducted a study on hyponatremia in elderly patients in an acute geriatric care unit and assessed its prevalence and prognosis. The sample consisted of 52.7% females and 47.3% males. Mean age was 83.6 years. Mean plasmatic sodium values were 137.3mmol/litre. Emergency lab test showed, out of 60 patients with hyponatremia 35 were in acute geriatric care unit. Cardiopulmonary were the most related causes of hyponatremia. Mean hospital length of stay was 12.8 days. Mortality of the hospitalized patients was 12.9%. They observed a statistic relationship between the presence of hyponatremia and a greater mean length of stay. No relationship was found between hyponatremia and mortality.15
Nandakumar et. al. in their study they concluded that hyponatremia is common in elderly. Severity of hyponatremia becomes greater as the age advances. Drowsiness is the common symptom. Seizures are present only in severe hyponatremia. Overall the commonest cause of hyponatremia is SIADH, followed by salt losing nephropathy. Diuretics, ACE-I are the commonest cause of drug induced SIADH. Among non-diabetic patients with SIADH, infections are the commonest cause for SIADH.16
6.3 / Objectives of the study:
1.  To assess the incidence of hyponatremia in hospitalized patients.
2.  To assess hyponatremia in relation to age and sex.
3.  To study the clinical profile of hyponatremia in these patients.
4.  To probe into the causes of hyponatremia.
5.  To correlate the outcome of patients with serum sodium levels on admission.
7 / Materials and Methods:
7.1 / Source of Data:
The study will be conducted on patients of either sex, admitted to Department of General Medicine in Navodaya Medical College Hospital and Research Centre, Raichur during the study period(one year) or 100 cases whichever is earlier.
7.2 / Methods of collection of Data :
Method of study: Data will be collected using a pretested proforma meeting the objectives of the study. Detailed history and necessary investigations will be undertaken. The purpose of the study will be explained to the patient and informed consent obtained.
Patients are selected for study who satisfy all inclusion and exclusion criteria. Relevant history including symptoms and signs at presentation, past medical history, drug history and examination findings are to be noted. Serum osmolality and urine osmolality is calculated with help of investigations.
Type of study: Hospital based prospective study
Period of the study: One year study.
Inclusion criteria:
·  Patients admitted in Department of Medicine age >18 yrs
·  Patients with serum sodium < 135meq/L
Exclusion criteria:
·  Patients admitted in Department of Medicine age <18 yrs
·  Post operative patients
7.3 / Does the study require any investigations or interventions to be conducted on patients or other humans or animals? If so, please describe briefly.
YES
Following investigations will be done after taking written informed consent,
ROUTINE INVESTIGATIONS:
·  Complete blood picture
·  Renal function test
·  Liver function test
·  Serum electrolytes
·  Urine routine
·  Chest x ray
·  ECG
SPECIAL INVESTIGATIONS:
·  USG abdomen
·  Urine electrolytes-sodium(Na+)
·  Serum uric acid - in whomsoever indicated
·  CT-Scan - in whomsoever indicated
7.4 / Has ethical clearance been obtained from your institution in case of 7.3?
Yes
8 / LIST OF REFERENCES :
1.  Harrisons principles of internal medicine,18th edition,p.344.
2.  MY Rao wt al. S Saravanan Hospital-Based Descriptive Study of Symptomatic Hyponatremia in Elderly Patients. JAPI, 2010; 58:667-669.

3.  Thomas Abraham Vurghese et al. Frequency and etiology of hyponatremia in adult hospitalized patients in medical wards of a general hospital in Kuwait. Kuwait medical journal 2006,38(3):211-213.

4.  Fulop T Jr, Worum I, Csongor J, Foris G, Leovey A. Body composition in elderly people. I. Determination of body composition by multiisotope method and the elimination kinetics of these isotopes in healthy elderly subjects. Gerontology. 1985;31:6–14.

5.  Rowe JW, Shock NW, DeFronzo RA. The influence of age on the renal response to water deprivation in man. Nephron. 1976;17:270–8.

6.  Phillips PA, Rolls BJ, Ledingham JG, Forsling ML, Morton JJ, Crowe MJ, et al. Reduced thirst after water deprivation in healthy elderly men. N Engl J Med. 1984;311:753–9.

7.  Beck LH. Changes in renal function with aging. Clin Geriatr Med. 1998;14:199-209.

8.  McLachlan M, Wasserman P. Changes in sizes and distensibility of the aging kidney. Br J Radiol. 1981;54:488–91.

9.  Lindeman RD, Tobin J, Shock NW. Longitudinal studies on the rate of decline in renal function with age. J Am Geriatr Soc. 1985;33:278–85.

10.  Chua M, Hoyle GE, Soiza RL. Prognostic implications of hyponatremia in elderly hospitalized patients. Arch Gerontol Geriatr. 2007 Nov-Dec;45(3):253-8.

11.  Rahil .A.I et al, Clinical profile of hyponatraemia in adult patients admitted to Hamad General Hospital, Qatar: experience with 53 cases . Prescribing practices of doctors in rural and urban india.Journal of Clinical and Diagnostic Research, 2009; 3:1419-1425.
12.  S Mahavir Agarwal et al. A comparative study of the clinico etiological profile of hyponatremia at presentation with that developing in hospital. Student IJMR 134, July 2011, pp 118-122.
13.  Nandini Chatterjee, Nilanjan Sengupta.A descriptive study of hyponatremia in a tertiary care hospital of Eastern India. Indian Journal of Endocrinology and Metabolism, 2012 ;16(2): 288-291.
14.  Miyashita J, Shimada T, Hunter AJ, Kamiya T. Impact of hyponatremia and the syndrome of inappropriate antidiuresis on mortality in elderly patients with aspiration pneumonia. J Hosp Med. 2012 Jul;7(6):464-9.
15.  Rubio-Rivas M, Formiga F, Cuerpo S, Franco J, di Yacovo S, Martínez C, Pujol R. Hyponatremia in elderly patients admitted in an acute geriatric care unit prevalence and prognosis. Med Clin (Barc). 2012 Jun 30;139(3):93-7.
16.  Nandakumar et.al Clinico-aetiological profile of hyponatremia in adults. Int J Biol Med Res. 2013; 4(1): 2802-2806.
9. / Signature of the Candidate
10. / Remarks of the Guide / Study gives vital informations in managing critically ill patients. Study can be done
11. / 11.1 / Name and Designation of
Guide (In block letters) / Dr.S.S.ANTIN
PROFESSOR&HEAD
DEPARTMENT OF GENERAL MEDICINE,
NAVODAYA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,
RAICHUR–584103.
11.2 / Signature
11.3 / Co-guide (if any)
11.4 / Signature
11.5 / Head of the Department / Dr. S.S.ANTIN
PROFESSOR& HEAD,
DEPARTMENT OF GENERAL MEDICINE,
NAVODAYA MEDICAL COLLEGE HOSPITAL AND RESEARCH CENTRE,
RAICHUR–584103.
11.6 / Signature
12 / 12.1 / Remarks of Chairman and Principal
12.2 / Signature