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Intravenous NAC Use in ACLF Patients

NCT05089981 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2021-10-22

No results posted yet for this study

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

Conditions

  • Acute on Chronic Liver Failure(ACLF)

Interventions

DRUG

N acetyl cysteine

Intravenous use of N acetyl cysteine in prescribed doses

DRUG

Placebo of N acetyl cysteine

Intravenous Placebo of N Acetyl cysteine in look alike form (Normal saline)

Sponsors & Collaborators

  • National Institute of Liver & GI Diseases, Pakistan

    collaborator OTHER

  • Aga Khan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-01
Primary Completion
2023-03-01
Completion
2023-03-01

Countries

  • Pakistan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05089981 on ClinicalTrials.gov