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

Primary Purpose

Acute on Chronic Liver Failure

Status
Recruiting
Phase
Not Applicable
Locations
India
Study Type
Interventional
Intervention
Carvedilol 12.5 MG
Sponsored by
Institute of Liver and Biliary Sciences, India
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute on Chronic Liver Failure

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Institute of Liver & Biliary SciencesRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Acute on Chronic Liver failure

Arm Description

Outcomes

Primary Outcome Measures

Liver transplant free survival

Secondary Outcome Measures

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

Full Information

First Posted
December 17, 2021
Last Updated
January 7, 2022
Sponsor
Institute of Liver and Biliary Sciences, India
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1. Study Identification

Unique Protocol Identification Number
NCT05180292
Brief Title
Acute Hemodynamic Response to Carvedilol in Predicting Survival in Acute on Chronic Liver Failure Patients - A Pilot Study.
Official Title
Acute Hemodynamic Response to Carvedilol in Predicting Survival in Acute on Chronic Liver Failure Patients - A Pilot Study.
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Recruiting
Study Start Date
January 7, 2022 (Actual)
Primary Completion Date
December 31, 2024 (Anticipated)
Study Completion Date
December 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Institute of Liver and Biliary Sciences, India

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute on Chronic Liver Failure

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Acute on Chronic Liver failure
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Carvedilol 12.5 MG
Intervention Description
Carvedilol 12.5 mg
Primary Outcome Measure Information:
Title
Liver transplant free survival
Time Frame
Day 28
Secondary Outcome Measure Information:
Title
Complications [PHT related bleed, AKI, infections, HE] within 90 days
Time Frame
90 days
Title
Liver transplant-free survival rate
Time Frame
90 days
Title
Correlation with evolution of AARC score
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Dr Chitranshu Vashishtha, DM
Phone
01146300000
Email
chitranshuv@gmail.com
Facility Information:
Facility Name
Institute of Liver & Biliary Sciences
City
New Delhi
State/Province
Delhi
ZIP/Postal Code
110070
Country
India
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dr Chitranshu Vashishtha, DM
Phone
01146300000
Email
chitranshuv@gmail.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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