Short Course of Tolvaptan for Cirrhotics with Hyponatremia Trial

A placebo controlled, randomized double blinded trial to evaluate the use of Tolvaptan for correction of hyponatremia in Liver Cirrhosis patients - SCoTCH

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2019/10/021479

Enrollment

100

Registered

2019-10-01

Start date

Unknown

Completion date

Unknown

Last updated

2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: K746- Other and unspecified cirrhosis ofliver

Interventions

Intervention1: Tolvaptan: T. Tolvaptan 15mg given per orally once daily for 7 days from start of study Control Intervention1: Placebo: Placebo given per orally once daily for 7 days from start of stud

Eligibility

Inclusion 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

Exclusion criteria: 1. Patients 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 9. Cerebrovascular accident within 30 days prior to the study

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

India

Contacts

Public ContactGeorge Jaocb Malayil

Amrita Institute of Medical Science

dr.george.j.malayil@gmail.com9995154021

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026