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

NCT05180292 | Unknown

• 1 other identifier: ILBS-ACLF-11
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Acute on Chronic Liver Failure

Outcome Measures

Primary Outcomes (1)

• Liver transplant free survival

  Day 28

Secondary Outcomes (3)

• 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

Study Arms (1)

Acute on Chronic Liver failure

EXPERIMENTAL

Drug: Carvedilol 12.5 MG

Interventions

Carvedilol 12.5 MG DRUG

Carvedilol 12.5 mg

Acute on Chronic Liver failure

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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,
• Age 18-70 yrs
• Baseline HVPG ≥ 12 mmHg.

You may not qualify if:

• Contraindications to NSBB (heart rate \< 65 /min, BP \< 110/65 mm Hg, asthma, heart failure),
• Portal Vein Thrombosis,
• Hepatocellular carcinoma,
• HVOTO,
• HE grades 2-4,
• NSBB therapy within 5 days,
• Pregnancy,
• Lactation,
• Planned for LT in the next 12 weeks
• No consent.

Sponsors & Collaborators

• Institute of Liver and Biliary Sciences, India: lead

Study Sites (1)

Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, 110070, India

RECRUITING

MeSH Terms

Conditions

Acute-On-Chronic Liver Failure

Interventions

Carvedilol

Condition Hierarchy (Ancestors)

Liver Failure, Acute; Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Propanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Propanols; Amines; Carbazoles; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Heterocyclic Compounds, 3-Ring

Central Study Contacts

Dr Chitranshu Vashishtha, DM

CONTACT

01146300000; chitranshuv@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 6, 2022
• Study Start: January 7, 2022
• Primary Completion: December 31, 2024
• Study Completion: December 31, 2024
• Last Updated: January 11, 2022

Record last verified: 2021-12

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)