Efficacy of Nonselective Beta Blocker vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices
1 other identifier
interventional
136
1 country
1
Brief Summary
Acute on chronic liver failure patients with HVPG (Hepatic Venous Pressure Gradient) ≥ 12 mmHg + No/small esophageal varices who present to the Department of Hepatology at Institute of Liver and Billiary Sciences, who meet the inclusion criteria and who provide informed consent.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Oct 2015
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2015
CompletedFirst Submitted
Initial submission to the registry
October 21, 2015
CompletedFirst Posted
Study publicly available on registry
October 22, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2017
CompletedJune 4, 2019
November 1, 2017
1.8 years
October 21, 2015
June 1, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Mortality in both groups
28 days
Secondary Outcomes (17)
Number of patients with development or progression of esophageal varices in both groups.
3 Months
Number of patients with reduction in hepatic venous pressure gradient (HVPG) in both groups.
3 Months
Number of patients with regression in esophageal varices in both groups.
3 Months
Number of patients with improvement in Liver severity scores in both groups.
28 days
Number of patients with improvement in Liver severity scores in both groups.
60 days
- +12 more secondary outcomes
Study Arms (2)
Carvedilol
EXPERIMENTALTab Carvedilol 3.125 mg twice daily followed by 6.25 mg BD and finally 12.5 mg BD if SBP \> 90 mmHg and HR \>55/min
placebo
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- Acute on Chronic Liver Failure as per APASL (Asian Pacific Association of Study of Liver Disease) criteria.
- years
- HVPG ≥ 12 + No/Small Esophageal varices
You may not qualify if:
- Bradycardia (HR \< 60/ min)
- Hypotension
- Asthma
- LVF
- AKI (Acute Kidney Injury), (S.creat \>1.5)
- Refractory ascites
- SBP (Spontaneous Bacterial Peritonitis)
- Pregnancy or Lactation
- Past history of EVL or EST
- Significant cardio - pulmonary co-morbidity
- PVT
- Presence of grades 3-4 hepatic encephalopathy (HE)
- Patients going for liver transplant in next 12 weeks
- No consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Institute of liver and Biliary Sciences
New Delhi, National Capital Territory of Delhi, 110070, India
Related Publications (1)
Kumar M, Kainth S, Choudhury A, Maiwall R, Mitra LG, Saluja V, Agarwal PM, Shasthry SM, Jindal A, Bhardwaj A, Kumar G, Sarin SK. Treatment with carvedilol improves survival of patients with acute-on-chronic liver failure: a randomized controlled trial. Hepatol Int. 2019 Nov;13(6):800-813. doi: 10.1007/s12072-019-09986-9. Epub 2019 Sep 20.
PMID: 31541422DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Dr Sumeet Kainth, MD
Institute of Liver and Biliary Sciences
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 21, 2015
First Posted
October 22, 2015
Study Start
October 1, 2015
Primary Completion
July 1, 2017
Study Completion
July 1, 2017
Last Updated
June 4, 2019
Record last verified: 2017-11