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

Not Applicable

Completed

• Conditions: Acute on Chronic Liver Failure
• Interventions: Drug: Placebo; Drug: Carvedilol

• Registration Number: NCT02583698
• Lead Sponsor: Institute of Liver and Biliary Sciences, India

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-10-01
• Study First Submitted: 2015-10-21
• Study First Submitted QC: 2015-10-21
• Study First Posted: 2015-10-22
• Primary Completion: 2017-07-01
• Study Completion: 2017-07-01
• Status Verified: 2017-11
• Last Update Submitted: 2019-06-01
• Last Update Posted: 2019-06-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 136

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
placebo	Placebo	-
Carvedilol	Carvedilol	Tab 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

Primary Outcome Measures

Name	Time	Method
Mortality in both groups	28 days

Secondary Outcome Measures

Name	Time	Method
Mortality in both groups	3 months
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 development of adverse events in both groups 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.	3 months
Number of patients who will develop esophageal variceal bleeding in both groups	3 Months
Development of complications in both groups	3 months	AKI,Pneumonia,SBP and other infections

Trial Locations

Locations (1)

Institute of liver and Biliary Sciences; 🇮🇳 New Delhi, Delhi, India