Alcoholic Hepatitis Clinical Trial
Official title:
Effects of Rifaximin Treatment in Patients With Acute Alcoholic Hepatitis: A Comparative Pilot Study
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.
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
;
Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
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