- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05180292
Acute Hemodynamic Response to Carvedilol in Predicting Survival in Acute on Chronic Liver Failure Patients - A Pilot Study.
January 7, 2022 updated by: Institute of Liver and Biliary Sciences, India
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Dr Chitranshu Vashishtha, DM
- Phone Number: 01146300000
- Email: chitranshuv@gmail.com
Study Locations
-
-
Delhi
-
New Delhi, Delhi, India, 110070
- Recruiting
- Institute of Liver & Biliary Sciences
-
Contact:
- Dr Chitranshu Vashishtha, DM
- Phone Number: 01146300000
- Email: chitranshuv@gmail.com
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Acute on Chronic Liver failure
|
Carvedilol 12.5 mg
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Liver transplant free survival
Time Frame: Day 28
|
Day 28
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Complications [PHT related bleed, AKI, infections, HE] within 90 days
Time Frame: 90 days
|
90 days
|
Liver transplant-free survival rate
Time Frame: 90 days
|
90 days
|
Correlation with evolution of AARC score
Time Frame: 2 weeks
|
2 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 7, 2022
Primary Completion (Anticipated)
December 31, 2024
Study Completion (Anticipated)
December 31, 2024
Study Registration Dates
First Submitted
December 17, 2021
First Submitted That Met QC Criteria
January 5, 2022
First Posted (Actual)
January 6, 2022
Study Record Updates
Last Update Posted (Actual)
January 11, 2022
Last Update Submitted That Met QC Criteria
January 7, 2022
Last Verified
December 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Digestive System Diseases
- Liver Diseases
- Liver Failure, Acute
- End Stage Liver Disease
- Liver Failure
- Hepatic Insufficiency
- Acute-On-Chronic Liver Failure
- Physiological Effects of Drugs
- Adrenergic beta-Antagonists
- Adrenergic Antagonists
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Antihypertensive Agents
- Vasodilator Agents
- Protective Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Antioxidants
- Adrenergic alpha-1 Receptor Antagonists
- Adrenergic alpha-Antagonists
- Carvedilol
Other Study ID Numbers
- ILBS-ACLF-11
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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