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:
- Primary endpoint: Bacterial infections after 90 days.
- 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 ]
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
- Hepatic Encephalopathy
- Acute Kidney Injury (including Hepatorenal Syndrome)
- Acute variceal bleeding
- Ascites
- 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