N-acetylcysteine: Day 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.
Study summary
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
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
Inclusion Criteria:
* 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.
* Acceptance of participation through written informed consent.
Exclusion Criteria:
* 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.
* Portal cavernomatosis.
* Any disease whose life expectancy is less than 12 months.
* Patients with nitroglycerin and / or carbamazepine-based treatments.
* Patients with uncontrolled active infection.
* Acute kidney disease with creatinine\> 2.5 mg / dL.
* Uncontrolled upper gastrointestinal bleeding.
* Concomitant uncontrolled diseases (HBV, HCV, HIV, TB, DILI, HCC or acute pancreatitis).
* Multiple organ failure or shock.
Primary outcome measure(s)
Number of Participants with all-cause mortality at 6 months. — 6 months. Main result variable.
Trial sites (1)
Facility
City
Region
Status
Ana Belén Fernández Laso
Vitoria-Gasteiz
Álava
Recruiting
More Bioaraba Health Research Institute trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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