Short Course of Tolvaptan for Cirrhotics with Hyponatremia Trial
Phase 1
- Conditions
- Health Condition 1: K746- Other and unspecified cirrhosis ofliver
- Registration Number
- CTRI/2019/10/021479
- Lead Sponsor
- Amrita Institute of Medical Science
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Patients aged between 18 and 75 years
2. Definite history of cirrhosis- signs and symptoms of decompensated cirrhosis, such as splenomegaly, hypersplenism, variceal bleeding, ascites, and hepatic encephalopathy or confirmed cirrhosis by measurements
3. Cirrhosis as evidenced by USG or Cross Sectional imaging
4. Hyponatremia (Na <125 mEq/L)
Exclusion Criteria
1. Patients < 18 years age
2. Pregnancy
3. Serum Creatinine > 1.5mg/dl
4. Nervous system diseases
5. Poorly controlled diabetes (fasting glucose > 220 mg/dL)
6. Heart failure with ascites
7. SIADH (as per Bartter-Schwartz criteria)
8. Anuria (urine volume < 100 mL/day)
9. Cerebrovascular accident within 30 days prior to the study
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To evaluate the ability of tolvaptan to correct hyponatremia in liver cirrhotic patients as compared to standard care aloneTimepoint: For a duration of 8 days, with necessary labs being repeated daily
- Secondary Outcome Measures
Name Time Method To assess for incidence of adverse events from the start of the study in both groups.Timepoint: For a duration of 8 days, with necessary labs being repeated daily;To assess the need for therapeutic tapping of ascites in both groups, after the start of therapyTimepoint: For a duration of 8 days, with necessary labs being repeated daily;To assess the weight loss in both groupsTimepoint: For a duration of 8 days, with necessary labs being repeated daily;To evaluate predictors of tolvaptan responsiveness.Timepoint: For a duration of 8 days, with necessary labs being repeated daily