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Study to see whether adding Midodrine to Carvedilol can better prevent early bleeding again in patients with severe liver disease

Carvedilol and Midodrine Versus Carvedilol Alone in Preventing Early Rebleed in Patients With Cirrhosis: A Randomized Controlled Trial. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/03/106015
Enrollment
210
Registered
2026-03-12
Start date
Unknown
Completion date
Unknown
Last updated
2026-03-30

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: Carvedilol with Midodrine: Oral Carvedilol will be up-titrated by 3.125 mg daily to a maximum of 6.25 mg twice daily. Oral Midodrine will be increased by 5 mg daily to a maximum of 15 m

Sponsors

Institute of Liver and Biliary Sciences
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Consecutive patients of cirrhosis with high risk acute variceal bleed (ChildP ugh class B more than 7 with active bleeding at initial endoscopy or Child Pugh class C less than 14 points).

Exclusion criteria

Exclusion criteria: 1. Age less than 18 years or more than 75 years. 2. HR less than 60 per min and BP less than 100 by 60 mm Hg 3. Child Pugh s score less than 8 and more than 13. 4. MELD score more than 30 and serum lactate more than 12mmol per L. 5. Refractory variceal bleed. 6. Preemptive TIPS or previous Porto-systemic shunt or TIPS. 7. Non-selective Beta blocker.(carvedilol or midodrine treatment in last 5 days. 8. Acute kidney injury HRS 9. Uncontrolled Hypertension (BP more than 140 b 90 mmHg), heart block, congestive heart failure. 10. Contraindication to NSBB (HRless than 60 per min, BP less than 90 by 60mmHg, bronchial asthma). 11. Hepatocellular carcinoma (outside Milan criteria), extrahepatic malignancy. 12. Pregnant women. 13. Bleeding from isolated gastric or ectopic varices.

Design outcomes

Primary

MeasureTime frame
Proportion of patients with early variceal rebleed in 6 weeks in both the groups.Timepoint: 6 weeks—

Secondary

MeasureTime frame
i. Liver transplant free survival at 6 weeks.Timepoint: 6 weeks;ii. Blood products Transfusion at 6 weeks.Timepoint: 6 weeks;iii. Need of rescue therapy at 6 weeks (Danis Ella stent / Sengstaken tube/ rescue TIPS).Timepoint: 6 weeks;iv. Change in HVPG at 4 weeks.Timepoint: 4 weeks ;v. New decompensation and further decompensation at 6 weeks.Timepoint: 6 weeks;vi. ICU stay and hospital stay duration.Timepoint: 6 weeks;vii. Change in MELD score at 6 weeks.Timepoint: 6 weeks;viii. Mean carvedilol dose in both groups at 6 weeks.Timepoint: 6 weeks;ix. Adverse events at 6 weeks.Timepoint: 6 weeks—

Countries

India

Contacts

Public ContactDr Chitranshu Vashishtha

Institute of Liver and Biliary Sciences

chitranshuv@gmail.com01146300000

Outcome results

None listed

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