Primary Objective To evaluate the efficacy and safety of 72 hour NAC treatment regimen in the
management of ACLF
Secondary Objective To evaluate the six weeks mortality and length of hospital stay in ACLF
patients treated with NAC
Randomized, Double blind pilot study of IV N-Acetyl cysteine for the treatment of ACLF.
Participants will be randomized into intervention and control arm using block randomization
by computer generated random numbers. Efficacy will be assessed by clinical improvement in
symptoms and signs of decompensated chronic liver disease (CLD). To assess safety degree of
adverse reactions will be observed. Periodic assessments until 28 day will be done consisting
of Physical exam, safety assessments, vital signs and lab tests.
Dose of Drug: 72 hour regimen consisting of three doses of intravenous N-Acetyl cysteine will
be used for a total dose of 300mg/kg.
Number of Patients: 100 Accrual period: 15 months
Phase:
N/A
Details
Lead Sponsor:
Aga Khan University
Collaborator:
National Institute of Liver & GI Diseases, Pakistan