Clinical Trial: Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Efficacy of N-acetylcysteine With or Without Steroids in Drug Induced Liver Injury: A Prospective Randomized Controlled Trial

Brief 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.

Detailed Summary:
Sponsor: Institute of Liver and Biliary Sciences, India

Current Primary Outcome: Proportion of patients with normalization of LFT (Liver Function Test) in both groups. [ Time Frame: 20 days ]

Normalization of LFT (Liver Function Test) which is defined as Total bilirubin within normal limits.


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Improvement in of Histology. [ Time Frame: 20 days ]
    Improvement is defined as decrease in inflammation, decrease in cholestasis.
  • Improvement in CBC profile [ Time Frame: 20 days ]
    Improvement is defined normalization of CBC profile.
  • Improvement in coagulation profile [ Time Frame: 20 days ]
    Improvement is defined normalization of Coagulation profile.
  • Improvement in KFT profile [ Time Frame: 20 days ]
    Improvement is defined normalization of KFT profile.
  • Proportion of patients develop adverse effects in both groups. [ Time Frame: 20 days ]


Original Secondary Outcome: Same as current

Information By: Institute of Liver and Biliary Sciences, India

Dates:
Date Received: February 8, 2016
Date Started: February 2016
Date Completion: December 2017
Last Updated: February 8, 2017
Last Verified: August 2016