Acute Hemodynamic Response to Carvedilol in Predicting Survival in Acute on Chronic Liver Failure Patients - A Pilot Study.

Institute of Liver and Biliary Sciences, India50 enrolled

Overview

Various parameters will be assessed during the procedure before and after 1 hour of 12.5 mg carvedilol such as HVPG (WHVP - FHVP), SVR, heart rate, cardiac output, cardiac index, Blood pressure (systolic, diastolic and mean), SpO2. Routine treatment of the patients will be continued as per the Institute protocol. These patients will be assessed for the liver transplant free survival at 28 days and complications \[PHT related bleed, AKI, infections, HE\] within 90 days; transplant-free survival rate at 90 days; evolution of the AARC score for 2 wk.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Acute on Chronic Liver Failure

Interventions

Carvedilol 12.5 MG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Patients of ACLF (APASL criteria) - jaundice (serum bilirubin ≥ 5 mg/dL and coagulopathy (INR ≥ 1.5) complicated within 4 weeks by clinical ascites and/or encephalopathy in a patient with previously diagnosed or undiagnosed chronic liver disease/cirrhosis, 2. Age 18-70 yrs 3. Baseline HVPG ≥ 12 mmHg. Exclusion Criteria: 1. Contraindications to NSBB (heart rate \< 65 /min, BP \< 110/65 mm Hg, asthma, heart failure), 2. Portal Vein Thrombosis, 3. Hepatocellular carcinoma, 4. HVOTO, 5. HE grades 2-4, 6. NSBB therapy within 5 days, 7. Pregnancy, 8. Lactation, 9. Planned for LT in the next 12 weeks 10. No consent.

Outcomes

Primary Outcomes

Liver transplant free survival

Time frame: Day 28

Secondary Outcomes

Complications [PHT related bleed, AKI, infections, HE] within 90 days

Time frame: 90 days

Liver transplant-free survival rate

Time frame: 90 days

Correlation with evolution of AARC score

Time frame: 2 weeks