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

NCT07765823 | Recruiting DMC

• 1 other identifier: 667/RC/KEMU
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Acute Liver Failure; Non-acetaminophine Induced Liver Failure

Keywords

hepatic failure; acute liver failure; acetylcysteine; randomized controlled trial; supportive care

Outcome Measures

Primary Outcomes (1)

• Survival/Mortality rate

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

  28 days after enrollment

Secondary Outcomes (1)

• Length of hospital stay

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

Other Outcomes (1)

• Improvement in Liver Function Tests

  4 days

Study Arms (2)

NAC Group

EXPERIMENTAL

Oral or nasogastric N-acetylcysteine, 140 mg/kg every 4 hours for the first 16 hours, then every 6-8 hours, continued for 3 days, plus standard supportive care. Intervention: Drug: N-acetylcysteine

Drug: N Acetyl Cysteine

Control Group

ACTIVE COMPARATOR

Standard supportive care protocol for acute liver failure (glucose control, antimicrobials, PPIs, fluid/electrolyte management, antiencephalopathy measures, FFP as needed). Intervention: Other: Standard Supportive Care

Other: Standard supportive care

Interventions

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.

Also known as: NAC

NAC Group

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).

Also known as: Supportive care protocol for liver failure

Control Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King Edward Medical University: lead

Study Sites (1)

King Edward Medical University/Mayo Hospital Lahore

Lahore, Punjab Province, 54000, Pakistan

RECRUITING

MeSH Terms

Conditions

Liver Failure, Acute; Liver Failure

Interventions

Acetylcysteine

Condition Hierarchy (Ancestors)

Hepatic Insufficiency; Liver Diseases; Digestive System Diseases

Intervention Hierarchy (Ancestors)

Cysteine; Amino Acids, Sulfur; Sulfur Compounds; Organic Chemicals; Amino Acids; Amino Acids, Peptides, and Proteins

Study Officials

• Somia Iqtadar, FCPS

  King Edward Medical University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Somia Iqtadar, FCPS

CONTACT

+92 42 99211129; somia.iqtadar@gmail.com

Zaeem Ahmad, MBBS

CONTACT

+92 42 99211129; zaeem.ahmad344@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr Somia Iqtadar

Model Details: Participants will be randomly allocated 1:1 to receive either oral/NG N-acetylcysteine plus standard supportive care, or standard supportive care alone, and followed in parallel for outcome assessment through day 28.

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 14, 2026
• Study Start: July 16, 2026
• Primary Completion (Estimated): October 15, 2026
• Study Completion (Estimated): October 17, 2026
• Last Updated: August 14, 2026

Record last verified: 2026-08

Locations

PA (1)