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Status:

COMPLETED

Intensive Enteral Nutrition and Acute Alcoholic Hepatitis

Lead Sponsor:

Erasme University Hospital

Conditions:

Severe Alcoholic Hepatitis

Eligibility:

All Genders

18-75 years

Phase:

NA

Brief 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.

Detailed Description

Acute alcoholic hepatitis (AAH) is characterized by hepatocellular necrosis, ballooning degeneration and an inflammatory reaction with many polymorphonuclear leukocytes, and fibrosis (Mezey E. Treatme...

Eligibility Criteria

Inclusion

  • 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

  • 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

Key Trial Info

Start Date :

February 1 2010

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

Estimated Enrollment :

136 Patients enrolled

Trial Details

Trial ID

NCT01801332

Start Date

February 1 2010

Last Update

February 28 2013

Active Locations (19)

Enter a location and click search to find clinical trials sorted by distance.

Page 1 of 5 (19 locations)

1

UZ Antwerpen

Antwerp, Belgium

2

AZ Brugge

Bruges, Belgium

3

CHU Saint-Pierre

Brussels, Belgium, 1000

4

CHU Brugmann

Brussels, Belgium, 1020