Clinical Trial: Efficacy of Nonselective Beta Blocker vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Interventional
Official Title: Efficacy of Nonselective Beta Blockers vs Placebo in Patients With Acute-on-chronic Liver Failure With Small/ no Esophageal Varices
Brief Summary: 250 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 Summary:
Sponsor: Institute of Liver and Biliary Sciences, India
Current Primary Outcome: Number of patients who will develop esophageal variceal bleeding in both groups [ Time Frame: During 3 Months ]
Original Primary Outcome: Reduction in Hepatic venous pressure gradient in both groups [ Time Frame: 3 months ]
Current Secondary Outcome:
- Number of patients with development of esophageal varices in both groups. [ Time Frame: 3 Months ]
- Survival in both groups [ Time Frame: 3 Months ]
- Transplant related survival in both groups [ Time Frame: 3 Months ]
- Number of patients with reduction in hepatic venous pressure gradient (HVPG) in both groups. [ Time Frame: 3 Months ]
- Number of patients with reduction in Liver Stiffness Measurement (LSM) in both groups. [ Time Frame: 3 Months ]
- Number of patients with regression in esophageal varices in both groups. [ Time Frame: 3 Months ]
- Number of patients with improvement in Liver severity scores in both groups. [ Time Frame: 3 Months ]
- Number of patients with development of adverse events in both groups in both groups. [ Time Frame: 3 Months ]
Original Secondary Outcome:
Information By: Institute of Liver and Biliary Sciences, India
Dates:
Date Received: October 21, 2015
Date Started: October 2015
Date Completion: October 2017
Last Updated: October 27, 2016
Last Verified: October 2016
