Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: N-acetylcysteine.
- Who it may be relevant to
- Registry conditions: Alcoholic Hepatitis. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Spain
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
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.
Other drugs that can contribute to improve the situation of patients with this entity is N-acetylcysteine (NAC), however, in the different studies contradictory data are obtained, therefore, different societies recommend conducting studies of greater scope to confirm the effectiveness of N-acetylcysteine and to be able to make a clear indication about N-acetylcysteines use.
Clinical, randomized, controlled, multicenter, parallel and open trial.
Interventions
- Drug 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.
Primary outcome measures
- Number of Participants with all-cause mortality at 6 months. [Time frame: 6 months.]
Secondary outcome measures (1)
- Number of participants with complications: infections, ascites, gastrointestinal bleeding, renal failure, hepatic encephalopathy, need for MARSH or orthotopic liver transplantation. [Time frame: 3 months]
Eligibility 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Spain · 1 center
- Ana Belén Fernández Laso — Vitoria-Gasteiz
Identifiers
NCT: NCT05294744 · CONACHAA · 2020-004549-35