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

• Status: Not yet recruiting
• Trial end date: 2023-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bioaraba Health Research Institute
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

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.