About this trial
This study is designed to evaluate the hypothesis that patients with severe acute alcoholic hepatitis have lower morbi-mortality if the patients receive treatment with corticosteroids + NAC, compared to patients that only receive corticosteroids.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Men and women.
Age from 18 to 75 years.
Patients with acute alcoholic hepatitis according to AASLD criteria or compatible liver histology.
Maddrey score> = 32.
Disqualifiers
Any cause of jaundice: acute hepatitis, positive HIV serology, biliary-pancreatic pathology, hemolytic anemia.
Allergy or intolerance to N-acetylcysteine and / or corticosteroids.
Hepatocarcinoma.
Portal cavernomatosis.
Trial design
Parallel
Treatments tested in this trial
N-acetylcysteine
DrugDay 1: 150 mg/kg in 250ml 5% glucose over 30min + 50mgr/kg in 500ml glucose over 4h + 100mgr/kg in 1000ml glucose over 16h intravenously. Day 2-14: 100mgr/kg in 1000 ml glucose/24h intravenously. Day 15 until end of corticosteroid treatment: NAC 600mg orally every 24h.
Treatment groups
Trial outcomes
Primary outcomes
Number of Participants with all-cause mortality at 6 months.
Main result variable.
Secondary outcomes
Number of participants with complications: infections, ascites, gastrointestinal bleeding, renal failure, hepatic encephalopathy, need for MARSH or orthotopic liver transplantation.
Security variable.
Sponsors and contacts
Click on the lead sponsor to view all of their trials.