Clinical trial NCT02583698: Efficacy of Nonselective Beta Blocker vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices
Official title: Efficacy of Nonselective Beta Blockers vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute on Chronic Liver Failure
Lead sponsor: Institute of Liver and Biliary Sciences, India
Sponsor class: OTHER
First posted: 2015-10-22
Enrollment: 136
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Acute on Chronic Liver Failure as per APASL (Asian Pacific Association of Study of Liver Disease) criteria.
2. 18-75 years
3. HVPG ≥ 12 + No/Small Esophageal varices

Exclusion Criteria:

1. Bradycardia (HR \< 60/ min)
2. Hypotension
3. Asthma
4. LVF
5. AKI (Acute Kidney Injury), (S.creat \>1.5)
6. Refractory ascites
7. SBP (Spontaneous Bacterial Peritonitis)
8. Pregnancy or Lactation
9. Past history of EVL or EST
10. Significant cardio - pulmonary co-morbidity
11. PVT
12. Presence of grades 3-4 hepatic encephalopathy (HE)
13. Patients going for liver transplant in next 12 weeks
14. No consent

Primary outcomes:
measure: Mortality in both groups
timeFrame: 28 days
Secondary outcomes:
measure: Number of patients with development or progression of esophageal varices in both groups.
timeFrame: 3 Months
measure: Number of patients with reduction in hepatic venous pressure gradient (HVPG) in both groups.
timeFrame: 3 Months
measure: Number of patients with regression in esophageal varices in both groups.
timeFrame: 3 Months
measure: Number of patients with improvement in Liver severity scores in both groups.
timeFrame: 28 days
measure: Number of patients with improvement in Liver severity scores in both groups.
timeFrame: 60 days
measure: Number of patients with improvement in Liver severity scores in both groups.
timeFrame: 3 months
measure: Number of patients with development of adverse events in both groups in both groups.
timeFrame: 28 days
measure: Number of patients with development of adverse events in both groups in both groups.
timeFrame: 2 months
measure: Number of patients with development of adverse events in both groups in both groups.
timeFrame: 3 Months
measure: Number of patients who will develop esophageal variceal bleeding in both groups
timeFrame: 28 days
measure: Number of patients who will develop esophageal variceal bleeding in both groups
timeFrame: 2 Months
measure: Number of patients who will develop esophageal variceal bleeding in both groups
timeFrame: 3 Months
measure: Development of complications in both groups
timeFrame: 28 days
measure: Development of complications in both groups
timeFrame: 2 months
measure: Development of complications in both groups
timeFrame: 3 months
measure: Mortality in both groups
timeFrame: 2 months
measure: Mortality in both groups
timeFrame: 3 months
Other outcomes:
Locations:
city: New Delhi
country: India
facility: Institute of liver and Biliary Sciences
state: Delhi
Study officials:
affiliation: Institute of Liver and Biliary Sciences
name: Dr Sumeet Kainth, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.