Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Se… (NCT05294744) | Clinical Trial Compass
RecruitingNot Applicable
Utility of the Use of N-acetylcysteine Associated With Conventional Treatment in Patients With Severe Acute Alcoholic Hepatitis (Maddrey> 32)
Spain390 participantsStarted 2022-10-07
Plain-language 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.
Who can participate
Age range18 Years – 75 Years
SexALL
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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.
What they're measuring
1
Number of Participants with all-cause mortality at 6 months.