Intensive Enteral Nutrition and Acute Alcoholic Hepatitis
Belgium136 participantsStarted 2010-02
Plain-language summary
To evaluate the effect of an intensive enteral nutrition (compared to clinical routine) in association with corticosteroïds in patients with severe acute alcoholic hepatitis.
Who can participate
Age range18 Years – 75 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Acute alcoholic hepatitis proven by a liver biopsy (necessary histological findings : neutrophils infiltration, ballooned hepatocytes and Mallory bodies)
* Presence of a severe disease, defined by a Maddrey score higher than or equal to 32, at screening and in baseline (day 0). Maddrey score = total bilirubin in mg/dl + 4,6 X (Prothrombin time patient in sec - prothrombin time control in sec)
* Age between 18 and 75 years old, extremes included
* Recent jaundice or in recent aggravation (less than 3 months)
* Chronic alcohol consumption (more than 40 g/day)
* Informed consent read, understand and signed by the patient (in case of significant encephalopathy, a family representative can signed in place of the patient)
* Maximal delay between admission and randomization of 14 days.
Exclusion Criteria:
* Other disease compromising 6 months survival of the patient
* Positive HIV or HCV serology, positive HBs Antigen
* Uncontrolled bacterial or fungal infection (infection must be judged controlled for at least 3 days)
* Uncontrolled upper GI bleeding (bleeding must be controlled for at least 5 days)
* Type 1 Hepatorenal syndrome (creatinin upper than 2,5 mg/dl), as defined by Salerno F et al, Gut 2007;56:1310-1318
* History of bariatric surgery
* Pentoxyphilline therapy
* MARS therapy