Efficacy of Nonselective Beta Blocker vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices

Institute of Liver and Biliary Sciences, India136 enrolled

Overview

Acute on chronic liver failure patients with HVPG (Hepatic Venous Pressure Gradient) ≥ 12 mmHg + No/small esophageal varices who present to the Department of Hepatology at Institute of Liver and Billiary Sciences, who meet the inclusion criteria and who provide informed consent.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

136

Conditions

Acute on Chronic Liver Failure

Interventions

CarvedilolDRUG

PlaceboDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Acute on Chronic Liver Failure as per APASL (Asian Pacific Association of Study of Liver Disease) criteria. 2. 18-75 years 3. HVPG ≥ 12 + No/Small Esophageal varices Exclusion Criteria: 1. Bradycardia (HR \< 60/ min) 2. Hypotension 3. Asthma 4. LVF 5. AKI (Acute Kidney Injury), (S.creat \>1.5) 6. Refractory ascites 7. SBP (Spontaneous Bacterial Peritonitis) 8. Pregnancy or Lactation 9. Past history of EVL or EST 10. Significant cardio - pulmonary co-morbidity 11. PVT 12. Presence of grades 3-4 hepatic encephalopathy (HE) 13. Patients going for liver transplant in next 12 weeks 14. No consent

Locations (1)

Institute of liver and Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Outcomes

Primary Outcomes

Mortality in both groups

Time frame: 28 days

Secondary Outcomes

Number of patients with development or progression of esophageal varices in both groups.

Time frame: 3 Months

Number of patients with reduction in hepatic venous pressure gradient (HVPG) in both groups.

Time frame: 3 Months

Number of patients with regression in esophageal varices in both groups.

Time frame: 3 Months

Number of patients with improvement in Liver severity scores in both groups.

Time frame: 28 days

Number of patients with improvement in Liver severity scores in both groups.

Time frame: 60 days

Number of patients with improvement in Liver severity scores in both groups.

Time frame: 3 months

Number of patients with development of adverse events in both groups in both groups.

Time frame: 28 days

Number of patients with development of adverse events in both groups in both groups.

Time frame: 2 months

Number of patients with development of adverse events in both groups in both groups.

Time frame: 3 Months

Number of patients who will develop esophageal variceal bleeding in both groups

Data from ClinicalTrials.gov

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