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

Acute on Chronic Liver Failure Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02583698
• Other study ID #: ILBS-ACLF-005
• Status: Completed
• Phase: N/A
• Start date: October 1, 2015
• Est. completion date: July 1, 2017

Study information

• Verified date: November 2017
• Source: Institute of Liver and Biliary Sciences, India
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 136
• Est. completion date: July 1, 2017
• Est. primary completion date: July 1, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute on Chronic Liver Failure
• Acute-On-Chronic Liver Failure
• End Stage Liver Disease
• Esophageal and Gastric Varices
• Hepatic Insufficiency
• Liver Failure

Intervention

Drug:
• Carvedilol

• Placebo

Locations

Country	Name	City	State
India	Institute of liver and Biliary Sciences	New Delhi	Delhi

Sponsors (1)

Lead Sponsor	Collaborator
Institute of Liver and Biliary Sciences, India

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality in both groups		28 days
Secondary	Number of patients with development or progression of esophageal varices in both groups.		3 Months
Secondary	Number of patients with reduction in hepatic venous pressure gradient (HVPG) in both groups.		3 Months
Secondary	Number of patients with regression in esophageal varices in both groups.		3 Months
Secondary	Number of patients with improvement in Liver severity scores in both groups.		28 days
Secondary	Number of patients with improvement in Liver severity scores in both groups.		60 days
Secondary	Number of patients with improvement in Liver severity scores in both groups.		3 months
Secondary	Number of patients with development of adverse events in both groups in both groups.		28 days
Secondary	Number of patients with development of adverse events in both groups in both groups.		2 months
Secondary	Number of patients with development of adverse events in both groups in both groups.		3 Months
Secondary	Number of patients who will develop esophageal variceal bleeding in both groups		28 days
Secondary	Number of patients who will develop esophageal variceal bleeding in both groups		2 Months
Secondary	Number of patients who will develop esophageal variceal bleeding in both groups		3 Months
Secondary	Development of complications in both groups	AKI,Pneumonia,SBP and other infections	28 days
Secondary	Development of complications in both groups	AKI,Pneumonia,SBP and other infections	2 months
Secondary	Development of complications in both groups	AKI,Pneumonia,SBP and other infections	3 months
Secondary	Mortality in both groups		2 months
Secondary	Mortality in both groups		3 months