Alcoholic hepatitis
Conditions
Brief summary
Rate of patients alive with compensated liver disease defined as a MELD score <17 at 90 days. MELD score will be calculated according to the formula given in Dunn et al. Hepatology 2005: MELD = 9.57 x ln (creatinine in mg/dL) + 3.78 x ln (bilirubin in mg/dL) + 11.2 x ln (INR) + 6.43
Detailed description
- Overall survival at 90 and 360 days ; - Rate of patients alive with compensated liver disease defined by a MELD score <17 at 30-days, 60-days,180 and 360 days, Therapeutic response at day 7 assessed by the rate of patients with a Lille score <0.45 as well as the Lille score treated as a continuous variable (assessing the degree of therapeutic response), - Cumulative incidence of infection within the first 90 days; - Cumulative incidence of hepatorenal syndrome within the first 90 days; - Serious adverse events within the first 90 days
Interventions
DRUGSOLUPRED 20 mg
DRUGHIDONAC 5 g/25 ml
DRUGDextrose 5% + Normal saline solutions (10%)
DRUGMicronized Prednisolone
Sponsors
Centre Hospitalier Universitaire De Lille
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Rate of patients alive with compensated liver disease defined as a MELD score <17 at 90 days. MELD score will be calculated according to the formula given in Dunn et al. Hepatology 2005: MELD = 9.57 x ln (creatinine in mg/dL) + 3.78 x ln (bilirubin in mg/dL) + 11.2 x ln (INR) + 6.43 | — |
Secondary
| Measure | Time frame |
|---|---|
| - Overall survival at 90 and 360 days ; - Rate of patients alive with compensated liver disease defined by a MELD score <17 at 30-days, 60-days,180 and 360 days, Therapeutic response at day 7 assessed by the rate of patients with a Lille score <0.45 as well as the Lille score treated as a continuous variable (assessing the degree of therapeutic response), - Cumulative incidence of infection within the first 90 days; - Cumulative incidence of hepatorenal syndrome within the first 90 days; - Serious adverse events within the first 90 days | — |
Countries
France
Outcome results
None listed