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
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
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
174
40 mg/d prednisolone N Acetyl Cysteine infusion 150mg/kg in 30 minutes then 50 mg/kg in 4 h then 100mg/kg in 16 h and finally 100mg/d2 to d5
Centre Hospitalier d'Abbeville
Abbeville, France
Centre Hospitalier Beauvais
Beauvais, France
Centre Hospitalier Universitaire de Besançon
Besançon, France
Centre Hospitalier Universitaire de Caen
Caen, France
Centre Hospitalier de Cambrai
Cambrai, France
Centre Hospitalier de Compiègne
Compiègne, France
Centre Hospitalier de Lens
Lens, France
Centre Hospitalier Saint-Antoine
Paris, France
Centre Hospitalier Universitaire Pitié-Salpétrière
Paris, France
Centre Hospitalier Universitaire de Reims
Reims, France
...and 3 more locations
Survival at one, three and six months
Time frame: six months
bilirubin decrease at day seven survival at one and three months nac tolerance side effects
Time frame: one, three and six months
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