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

Sponsors

Lead Sponsor: Institute of Liver and Biliary Sciences, India

Source 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.

Overall Status Completed
Start Date October 1, 2015
Completion Date July 1, 2017
Primary Completion Date July 1, 2017
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Mortality in both groups 28 days
Secondary Outcome
Measure Time Frame
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
Number of patients with improvement in Liver severity scores in both groups. 3 months
Number of patients with development of adverse events in both groups in both groups. 28 days
Number of patients with development of adverse events in both groups in both groups. 2 months
Number of patients with development of adverse events in both groups in both groups. 3 Months
Number of patients who will develop esophageal variceal bleeding in both groups 28 days
Number of patients who will develop esophageal variceal bleeding in both groups 2 Months
Number of patients who will develop esophageal variceal bleeding in both groups 3 Months
Development of complications in both groups 28 days
Development of complications in both groups 2 months
Development of complications in both groups 3 months
Mortality in both groups 2 months
Mortality in both groups 3 months
Enrollment 136
Condition
Intervention

Intervention Type: Drug

Intervention Name: Carvedilol

Arm Group Label: Carvedilol

Intervention Type: Drug

Intervention Name: Placebo

Arm Group Label: placebo

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

Gender: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Healthy Volunteers: No

Overall Official
Last Name Role Affiliation
Dr Sumeet Kainth, MD Principal Investigator Institute of Liver and Biliary Sciences
Location
Facility: Institute of liver and Biliary Sciences
Location Countries

India

Verification Date

November 2017

Responsible Party

Type: Sponsor

Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: Carvedilol

Type: Experimental

Description: 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

Label: placebo

Type: Placebo Comparator

Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov