CTRI/2019/10/021479Not yet recruitingPhase 1
A placebo controlled, randomized double blinded trial to evaluate the use of Tolvaptan for correction of hyponatremia in Liver Cirrhosis patients - SCoTCH
Amrita Institute of Medical Science0 sites0 target enrollmentStarted: TBDLast updated:
Trial Snapshot
- Phase
- Phase 1
- Status
- Not yet recruiting
- Sponsor
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
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
Investigators
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