Intravenous NAC Use in ACLF Patients

• Status: Not yet recruiting
• Trial end date: 2023-03-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Aga Khan University
• Collaborator: National Institute of Liver & GI Diseases, Pakistan
• Treatments: Acetylcysteine; N-monoacetylcystine

Criteria

Inclusion Criteria:

• Criteria for inclusion will be

• Age between 18 and 70 years

• Establishment of ACLF grade 1-3 according to EASL- CLIFF criteria

• Willing to provide informed consent to participate in the study (by study subject or next of kin)

Exclusion Criteria:

• Criteria for exclusion will be

• History of hypersensitivity to NAC

• Hepatocellular carcinoma

• pregnancy

• Advanced cardiovascular or pulmonary disease

• Advanced primary neurological disease (such as stroke)