RecruitingNot ApplicableNCT05294744

Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)

Sponsor

Bioaraba Health Research Institute

Enrollment

390 participants

Start Date

Oct 7, 2022

Study Type

INTERVENTIONAL

Conditions

Alcoholic Hepatitis

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

Min Age: 18 YearsMax Age: 75 Years

Inclusion Criteria5

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 Criteria12

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.

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Interventions

DRUGN-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.