Intravenous NAC Use in ACLF Patients

Summary

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

Timeline

Start

2021-11-01

Primary completion

2023-03-01

Completion

2023-03-01

Drugs

Indications