Health Trials

Role of N-Acetylcysteine in Non-Acetaminophen-Induced Liver Failure

ConditionAcute Liver Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-60
SponsorKing Edward Medical University

About this trial

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).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • N Acetyl Cysteine

    Drug

    Oral or nasogastric N-acetylcysteine administered at 140 mg/kg every 4 hours for the first 16 hours, followed by 140 mg/kg every 6-8 hours, continued for a total duration of 3 days, given in addition to standard supportive care.

  • Standard supportive care

    Other intervention

    Standard supportive care protocol for acute liver failure (glucose control, antimicrobials, PPIs, fluid/electrolyte management, anti-encephalopathy measures, FFP as needed).

Treatment groups

62 Participants
are divided into 2 treatment groups
Group A: NAC GroupExperimental treatment 1 intervention
Group B: Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Survival/Mortality rate

Proportion of patients alive (survival) vs. deceased (mortality) at day 28.

Time frame
28 days after enrollment

Secondary outcomes

1

Length of hospital stay

Lenght of Hospital stay from admission to death/discharge.

Time frame
From admission to discharge or death (up to 28 days)

Other outcomes

1

Change in Liver Function Tests

Improvement/Decline in liver function tests from Baseline to day i.e Change in bilirubin, albumin, INR, AST, ALT from baseline to day 4.

Time frame
4 days

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

King Edward Medical University

Lead sponsor

Source ClinicalTrials.gov
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