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NCT Number: NCT07765823

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

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).

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

King Edward Medical University/Mayo Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

Location status: Recruiting

Location contact

Israr Toor, FCPS

CONTACT

[email protected]

+92 42 99211129 ext. 331

Somia Iqtadar, FCPS

SUB_INVESTIGATOR

Zaeem Ahmad, MBBS

PRINCIPAL_INVESTIGATOR

CONTACT

[email protected]

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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.

Treatment and study plan

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.

Other names: NAC

Standard supportive care

Other

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

Other names: Supportive care protocol for liver failure

Primary outcomes

  1. Survival/Mortality rate

    Time frame: 28 days after enrollment

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

Secondary outcomes

  1. Length of hospital stay

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

    Lenght of Hospital stay from admission to death/discharge.

Other outcomes

  1. Change in Liver Function Tests

    Time frame: 4 days

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

Study contacts

Contact information is provided by the study sponsor or research team.

Somia Iqtadar, FCPS

CONTACT

[email protected]

+92 42 99211129 ext. 331

Zaeem Ahmad, MBBS

CONTACT

[email protected]

+92 42 99211129 ext. 331

Sponsors and collaborators

Lead sponsor

King Edward Medical University

Other

Registry information

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Aug 14, 2026
Registry last updated
Aug 19, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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