Granulocyte Colony Stimulating Factor Four Week Plus N-Acetyl Cysteine in Severe Alcoholic Hepatitis
Alcoholic Hepatitis
About this trial
This is an interventional treatment trial for Alcoholic Hepatitis focused on measuring alcoholic hepatitis, alcoholic liver disease, regeneration
Eligibility Criteria
Inclusion Criteria: • Alcoholic hepatitis patients(More than 10 years of heavy alcohol consumption (mean intake ≈ 100 g/day);Elevated aspartate aminotransferase level (but <500 IU per millilitre) and Ratio ofAST/ALT≥2 times;Elevated serum total bilirubin level ≥ 5 mgdL (86 μmol/L);Elevated INR(≥1.5) and;Neutrophilia. Patient with Maddrey's DF of≥ 32 will be included in the study, with or without biopsy) Exclusion Criteria: Age < 18 and > 75 years Hepatocellular carcinoma or portal vein thrombosis Refusal to participate in the study Serum creatinine >1.0 mg% Hepatic encephalopathy- grade 3 or 4 Upper gastrointestinal bleed in last ten days Uncontrolled bacterial infection Human immunodeficiency virus, Hepatitis B virus, Hepatitis C virus seropositivity, Autoimmune hepatitis, hemochromatosis, Wilson's disease, alpha1-antitrypsin deficiency Pregnancy Glucocorticoid treatment Significant co-morbidity Previous known hypersensitivity to G-CSF/NAC
Sites / Locations
- Dept of Hepatology, PGIMER
Arms of the Study
Arm 1
Arm 2
Arm 3
Active Comparator
Experimental
Experimental
Standard Medical therapy
G-CSF
G-CSF and NAC
Standard medical therapy involves primary treatment with normal hospital nutrition (1800 to 2000 kcal per day). Diuretics, sodium restriction and albumin for treatment of ascites or fresh frozen plasma for coagulopathy or antibiotics for any focus of infection as spontaneous bacterial peritonitis (SBP), pneumonia, cellulitis, and urinary tract infection as indicated.
Standard Medical Therapy plus G-CSF- 5μg/Kg s.c every 12 hours for 5 consecutive days
Standard Medical Therapy plus G-CSF with intravenous NAC (day 1: NAC at 150, 50, and 100 mg/kg in 250, 500, and 1000 ml of 5% glucose solution over 30 minutes, 4 hours, and 16 hours, respectively; days 2 through 5: 100 mg/kg/day in 1000 ml of 5% glucose solution followed by oral NAC from days 6 to 28)