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

NCT ID: NCT05180292

Last Updated: 2022-01-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-07

Study Completion Date

2024-12-31

Brief Summary

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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

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Conditions

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Acute on Chronic Liver Failure

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Acute on Chronic Liver failure

Group Type EXPERIMENTAL

Carvedilol 12.5 MG

Intervention Type DRUG

Carvedilol 12.5 mg

Interventions

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Carvedilol 12.5 MG

Carvedilol 12.5 mg

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Institute of Liver and Biliary Sciences, India

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Institute of Liver & Biliary Sciences

New Delhi, National Capital Territory of Delhi, India

Site Status RECRUITING

Countries

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India

Central Contacts

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Dr Chitranshu Vashishtha, DM

Role: CONTACT

01146300000

Facility Contacts

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Dr Chitranshu Vashishtha, DM

Role: primary

01146300000

Other Identifiers

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ILBS-ACLF-11

Identifier Type: -

Identifier Source: org_study_id

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