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

Not Applicable

Recruiting

• Conditions: Acute on Chronic Liver Failure
• Interventions: Drug: Carvedilol 12.5 MG

• Registration Number: NCT05180292
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-12
• Study First Submitted: 2021-12-17
• Study First Submitted QC: 2022-01-05
• Study First Posted: 2022-01-06
• Study Start: 2022-01-07
• Last Update Submitted: 2022-01-07
• Last Update Posted: 2022-01-11
• Primary Completion: 2024-12-31
• Study Completion: 2024-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Acute on Chronic Liver failure	Carvedilol 12.5 MG	-

Primary Outcome Measures

Name	Time	Method
Liver transplant free survival	Day 28

Secondary Outcome Measures

Name	Time	Method
Complications [PHT related bleed, AKI, infections, HE] within 90 days	90 days
Liver transplant-free survival rate	90 days
Correlation with evolution of AARC score	2 weeks

Trial Locations

Locations (1)

Institute of Liver & Biliary Sciences; 🇮🇳 New Delhi, Delhi, India