Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury
Status:
Terminated
Trial end date:
2016-08-31
Target enrollment:
Participant gender:
Summary
Intervention - Subjects will be randomized to 2 groups
Group A - subjects will receive Prednisolone for 20 days with NAC (N-Acetylcysteine)
Group B - will receive NAC (N-Acetylcysteine) only NAC (N-acetylcysteine) dosing
Loading dose: 150 mg/kg IV; mix in 200 mL of 5% dextrose in water (D5W) and infuse over 1
hour
Dose 2: 50 mg/kg IV in 500 mL D5W over 4 h
Dose 3: 100 mg/kg IV in 1000 mL D5W over 16 h
- Monitoring and assessment-Liver Biopsy at baseline and at 3 months, Liver Function Test
at regular intervals.
- Stopping rule-Development of sepsis, worsening of Liver functions.