Status:
UNKNOWN
Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
Lead Sponsor:
Bioaraba Health Research Institute
Conditions:
Alcoholic Hepatitis
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief 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 ...
Detailed Description
Currently there are no drugs available to cure patients with acute alcoholic hepatitis. The only treatment available is corticosteroids, the efficacy of which is limited and not free of side effects. ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2023
Estimated Enrollment :
390 Patients enrolled
Trial Details
Trial ID
NCT05294744
Start Date
April 1 2022
End Date
July 1 2023
Last Update
March 24 2022
Active Locations (1)
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1
Ana Belén Fernández Laso
Vitoria-Gasteiz, Álava, Spain, 01009