Clinical Trial: Treatment of Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Treatment of Acute Severe Alcoholic Hepatitis With Corticoids Plus N Acetyl Cysteine Versus Corticoids Alone: a French Multicentre Randomized Controlled Study.
Brief Summary: 35% of Acute Alcoholic Hepatitis patients (AAH) do not respond to corticoids and died after 6 months. Chronic alcohol abuse depletes glutathione in the hepatocytes and makes the latter more sensitive to excessive TNFα levels. Re-establishment of a stock of antioxidants by administration of a precursor (N-acetyl cysteine, NAC) in combination with corticoids (C) could make the hepatocytes more resistant and improve survival. The investigators' study's primary endpoint was improvement of survival at 6 months. The secondary endpoints were survival at 1 and 3 months, tolerance of NAC and a drop in blood bilirubin levels at D7
Detailed Summary: AAH patients (Maddrey score > 32 and compatible histological results) should centrally randomized into the C-NAC or C groups. Both groups received 4 weeks of prednisolone treatment, plus NAC for the combination therapy group (D1: 150, 50 and 100 mg/kg in 250, 500 and 1000 mL of 5% glucose-saline (G5%) respectively, at t=30 minutes, 4 and 16 hours; D2 to D5, 100 mg/kg in 1000 mL of G5%). Group C received 1000 mL of G5%, D1-5
Sponsor: Centre Hospitalier Universitaire, Amiens
Current Primary Outcome: Survival at one, three and six months [ Time Frame: six months ]
Original Primary Outcome: Same as current
Current Secondary Outcome: bilirubin decrease at day seven survival at one and three months nac tolerance side effects [ Time Frame: one, three and six months ]
Original Secondary Outcome: Same as current
Information By: Centre Hospitalier Universitaire, Amiens
Dates:
Date Received: March 17, 2009
Date Started: April 2004
Date Completion:
Last Updated: October 19, 2009
Last Verified: October 2009
