ROLE OF N-ACETYLCYSTEINE IN NON-ACETAMINOPHEN-INDUCED LIVER FAILURE

Registry ID
NCT07765823
Source registry
NCT
Status
RECRUITING
Phase
NA
Study type
INTERVENTIONAL
Sponsor
King Edward Medical University
Enrollment
62
Start date
2026-07-16
Completion date
2026-10-17
Last update
2026-08-14

Conditions

Summary

This randomized controlled trial evaluates whether oral N-acetylcysteine (NAC), given alongside standard supportive care, improves survival and reduces mortality in patients with non-acetaminophen-induced acute liver failure (ALF), compared to supportive care alone. Secondary objectives are to assess NAC's effect on length of hospital stay and improvement in liver function tests. Sixty-two adult patients (18-60 years) will be randomized 1:1 to NAC or control, with outcomes assessed at 28 days (survival/mortality) and day 4 (liver function tests).

Detailed description

Acute liver failure carries high mortality, and in resource-limited settings like Pakistan, liver transplantation is often inaccessible, making pharmacologic adjuncts to supportive care important. Prior studies (Nabi et al. 2017; Mumtaz et al. 2009; Parkas et al. 2016) suggest oral NAC may improve survival and shorten hospital stay in non-acetaminophen ALF, though evidence remains limited. This trial will randomly assign eligible patients via computer-generated randomization to receive oral/NG NAC (140 mg/kg every 4 hours for 16 hours, then every 6-8 hours, continued for 3 days) plus standard supportive care, or standard supportive care alone. Standard care includes glucose monitoring, prophylactic antimicrobials, proton pump inhibitors, fluid/electrolyte management, anti-encephalopathy measures as needed, and fresh frozen plasma for bleeding. Patients will be followed for up to 28 days.

Interventions

Inclusion criteria

Inclusion Criteria: * Male or female, aged 18-60 years * Diagnosed with non-acetaminophen- induced acute hepatic failure (per operational definition/EASL criteria) * Etiology other than acetaminophen overdose (viral hepatitis HAV/HBV/HEV, non-acetaminophen drug-induced liver injury, or idiopathic) * No NAC treatment received for current episode prior to enrollment

Exclusion criteria

Exclusion Criteria: * History of chronic liver disease or cirrhosis * Prior severe cardiac, renal, neurological, or infectious disease that could confound outcomes * Prior liver transplant or current transplant candidacy * Known allergy/contraindication to NAC * Pregnant women.

Primary outcomes

[{"measure":"Survival/Mortality rate","timeFrame":"28 days after enrollment"}]

Locations

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