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Clinical Trials/CTRI/2019/10/021479
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

Sponsor
Amrita Institute of Medical Science

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