Clinical Trial: Effects of Rifaximin in Patients With Acute Alcoholic Hepatitis

Study Status: Enrolling by invitation
Recruit Status: Enrolling by invitation
Study Type: Interventional

Official Title: Effects of Rifaximin Treatment in Patients With Acute Alcoholic Hepatitis: A Comparative Pilot Study

Brief Summary:

Acute alcoholic hepatitis (AAH) is a serious condition and one of the most frequent causes of Acute-on-Chronic Liver Failure. The current standard therapy (corticosteroids) is theme of debate and unsatisfactory in many patients (year mortality: 30%). One of the main causes of death is bacterial infections, which affect 40-50% of patients at 90 days. Intestinal decontamination with rifaximin (a nonabsorbable antibiotic) reduces endotoxemia, improves liver function and reduces the complications of decompensated alcoholic cirrhosis.

The Hypothesis/Objective: To assess whether oral decontamination with rifaximin prevents the development of infections associated with AAH and analyze its consequences.


Detailed Summary:

Design: Open multicenter comparative study. A cohort (n = 66) will receive rifaximin (1200 mg / d) for 90 days. Results will be compared with those of a cohort of AAH prospectively included in an observational study. Both groups with a uniform treatment protocol (which includes the administration of corticosteroids and standardized treatment for complications of liver failure). Patients will be monitorized until hospital discharge and a follow-up visit at 7, 30, 45, 60 and 90 days will be performed.

Endpoints:

  1. Primary endpoint: Bacterial infections after 90 days.
  2. Secondary endpoints: :

2.1. Liver function tests 2.2. Levels of endotoxemia 2.3. Complications of liver cirrhosis. 2.4. Survival


Sponsor: Hospital Universitari Vall d'Hebron Research Institute

Current Primary Outcome: Rate of bacterial infections [ Time Frame: 90 days ]

Development of any bacterial infection.


Original Primary Outcome: Same as current

Current Secondary Outcome: Rate of Decompensations of Liver Cirrhosis [ Time Frame: 90 days ]

Development of any liver cirrhosis decompensations

  1. Hepatic Encephalopathy
  2. Acute Kidney Injury (including Hepatorenal Syndrome)
  3. Acute variceal bleeding
  4. Ascites
  5. Death


Original Secondary Outcome: Same as current

Information By: Hospital Universitari Vall d'Hebron Research Institute

Dates:
Date Received: April 15, 2014
Date Started: April 2013
Date Completion: December 2016
Last Updated: November 3, 2016
Last Verified: November 2016