Efficacy of Nonselective Beta Blocker vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices

Efficacy of Nonselective Beta Blockers vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02583698

Enrollment

136

Registered

2015-10-22

Start date

2015-10-01

Completion date

2017-07-01

Last updated

2019-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute on Chronic Liver Failure

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.

Interventions

DRUGCarvedilol

DRUGPlacebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Mortality in both groups	28 days

Secondary

Measure	Time frame	Description
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 development or progression of esophageal varices in both groups.	3 Months	—
Number of patients who will develop esophageal variceal bleeding in both groups	28 days	—
Development of complications in both groups	28 days	AKI,Pneumonia,SBP and other infections
Mortality in both groups	2 months	—
Number of patients with development of adverse events in both groups in both groups.	28 days	—

Countries

India

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 1, 2026