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| ID | Type | Description | Link |
|---|---|---|---|
| AFSSAPS 040276 |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Corticoids plus N Acetyl Cysteine | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Corticoids plus N Acetyl Cysteine | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Survival at one, three and six months | six months |
| Measure | Description | Time Frame |
|---|---|---|
| bilirubin decrease at day seven survival at one and three months nac tolerance side effects | one, three and six months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Phillippe DOMY | Centre Hospitalier Universitaire, Amiens | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre Hospitalier d'Abbeville | Abbeville | France | ||||
| Centre Hospitalier Beauvais |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22070475 | Derived | Nguyen-Khac E, Thevenot T, Piquet MA, Benferhat S, Goria O, Chatelain D, Tramier B, Dewaele F, Ghrib S, Rudler M, Carbonell N, Tossou H, Bental A, Bernard-Chabert B, Dupas JL; AAH-NAC Study Group. Glucocorticoids plus N-acetylcysteine in severe alcoholic hepatitis. N Engl J Med. 2011 Nov 10;365(19):1781-9. doi: 10.1056/NEJMoa1101214. |
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|
| Beauvais |
| 60000 |
| France |
| Centre Hospitalier Universitaire de Besançon | Besançon | 25030 | France |
| Centre Hospitalier Universitaire de Caen | Caen | 14000 | 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 |
| Centre Hospitalier Universitaire de Rouen | Rouen | 76031 | France |
| Centre Hospitalier de Saint-Quentin | Saint-Quentin | France |
| Centre Hospitalier de Valenciennes | Valenciennes | France |
| ID | Term |
|---|---|
| D006519 | Hepatitis, Alcoholic |
| D005355 | Fibrosis |
| D008108 | Liver Diseases, Alcoholic |
| ID | Term |
|---|---|
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D020751 | Alcohol-Induced Disorders |
| D019973 | Alcohol-Related Disorders |
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000305 | Adrenal Cortex Hormones |
| D000111 | Acetylcysteine |
| ID | Term |
|---|---|
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D003545 | Cysteine |
| D000603 | Amino Acids, Sulfur |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D000596 | Amino Acids |
| D000602 | Amino Acids, Peptides, and Proteins |
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