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

Institute of Liver and Biliary Sciences, India

Status: Enrolling

Conditions: Acute on Chronic Liver Failure

Treatments: Drug: Carvedilol 12.5 MG

Study type: Interventional

Funder types: Other

Identifiers

NCT05180292

ILBS-ACLF-11

Details and patient eligibility

About

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.

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Acute on Chronic Liver failure

Experimental group

Treatment:

Drug: Carvedilol 12.5 MG