Clinical Trial: Corticosteroids in Severe Alcoholic Hepatitis Patients With Early Spontaneous Improvement

Study Status: Not yet recruiting
Recruit Status: Not yet recruiting
Study Type: Interventional

Official Title: Corticosteroids in Severe Alcoholic Hepatitis Patients With Early Spontaneous Improvement

Brief Summary: Approximately 50% of patients admitted for severe AH will have spontaneous improvement of liver function before initiation of therapy (ie decrease in mDF between hospital admission and initiation of steroids). These patients have a better prognosis than patients without spontaneous improvement of liver function. It has never been demonstrated that corticosteroids improve survival in severe AH patients with spontaneous improvement of liver function. Our hypothesis is that severe AH patients with spontaneous improvement of liver function represent a group who could most benefit from steroids

Detailed Summary:
Sponsor: Erasme University Hospital

Current Primary Outcome: Mortality at 90 days [ Time Frame: 90 days ]

To determine whether Methylprednisolone compared to placebo improve the 90 day mortality from patients with severe AH and spontaneous improvement of liver function


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Mortality at 28 days [ Time Frame: 28 days ]
    To determine the 28 day mortality from patients with severe AH and spontaneous liver function improvement treated with Methylprednisolone or placebo
  • Incidence of infections during the study period (90 days) [ Time Frame: 90 days ]
    To determine the incidence of infections during the 90 day study period in corticosteroid-treated compared to placebo-treated patients


Original Secondary Outcome: Same as current

Information By: Erasme University Hospital

Dates:
Date Received: May 18, 2017
Date Started: June 2017
Date Completion: January 2021
Last Updated: May 18, 2017
Last Verified: May 2017