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

NCT06872372 | Active Not Recruiting

• 1 other identifier: LahoreGeneralH3
• Study Type: interventional
• Target: 62
• Locations: 1 country
• Sites: 1

Brief Summary

Acute liver failure (ALF) is a serious condition in which the liver suddenly stops working, often leading to life-threatening complications. While N-Acetylcysteine (NAC) is widely used to treat ALF caused by acetaminophen overdose, its benefits in ALF due to other causes, such as viral infections or drug reactions, remain uncertain. This study is a randomized controlled trial designed to investigate whether NAC can improve survival rates and reduce hospital stays in patients with non-acetaminophen-induced ALF. Participants will be randomly assigned to receive either NAC along with standard supportive care or standard supportive care alone. The study will measure survival rates, hospital stay duration, and improvement in liver function tests. By exploring NAC's potential benefits beyond acetaminophen-related cases, this research aims to provide evidence-based guidance on how to better manage patients with ALF from other causes.

Conditions

Acute Liver Failure; Drug-Induced Liver Injury

Keywords

Non-Acetaminophen-Induced Liver Injury; N-Acetylcysteine (NAC); Drug-Induced Hepatotoxicity

Outcome Measures

Primary Outcomes (2)

• Survival Rate

  It is defined as the proportion of patients with non-acetaminophen-induced acute liver injury who remain alive at 28th day after enrollment.

  28 days post-enrollment

• Mortality Rate

  Proportion of patients who die within 28 days after enrollment in the study.

  28 days post-enrollment

Secondary Outcomes (1)

• Length of Hospital Stay

  Through study completion, an average of 28 days

Study Arms (2)

NAC Group

EXPERIMENTAL

Participants in this group received N-Acetylcysteine (NAC) along with standard supportive care for acute liver failure. NAC was administered orally or via a nasogastric tube.

Drug: N-Acetylcysteine (NAC) Treatment

Control Group

PLACEBO COMPARATOR

Participants in this group received only standard supportive care, without N-Acetylcysteine (NAC).

Other: Standard supportive care

Interventions

N-Acetylcysteine (NAC) Treatment DRUG

Participants in this group received N-Acetylcysteine (NAC) at a dose of 140 mg/kg orally or via a nasogastric tube every 4 hours for the first 16 hours, followed by the same dose at intervals of 6-8 hours for a total of 3 days, alongside standard supportive care for acute liver failure.

NAC Group

Standard supportive care OTHER

Participants in this group received only standard supportive care for acute liver failure, without N-Acetylcysteine (NAC). Standard supportive care included measures to prevent hypoglycemia, administration of broad-spectrum antimicrobials, proton pump inhibitors, fluid and electrolyte balance maintenance, and supportive treatment for hepatic encephalopathy.

Control Group

Eligibility Criteria

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

You may qualify if:

• Patients with either gender (male or female) aged 18-60 years.
• Diagnosed with non-acetaminophen-induced acute hepatic failure (NAI-AHF) as per operational definition.
• Cases where the etiology is attributed to factors other than acetaminophen overdose, including viral hepatitis (HAV, HBV, HEV), drug-induced liver injury (excluding acetaminophen), or idiopathic causes.
• Patients who have not received N-acetylcysteine (NAC) treatment for the current episode of acute hepatic failure before enrollment.

You may not qualify if:

• Patients with a history of chronic liver disease or cirrhosis.
• Patients with previous history of severe cardiac, renal, neurological, or infectious diseases that could confound treatment outcomes.
• Patients who have undergone a liver transplant or potential candidate of liver transplant.
• Known allergy or contraindication to N-acetylcysteine.
• Pregnant women.

Sponsors & Collaborators

• Lahore General Hospital: lead

Study Sites (1)

Lahore General Hospital, Lahore

Lahore, Punjab Province, 54000, Pakistan

Location

MeSH Terms

Conditions

Liver Failure, Acute; Chemical and Drug Induced Liver Injury

Interventions

Acetylcysteine; Therapeutics

Condition Hierarchy (Ancestors)

Liver Failure; Hepatic Insufficiency; Liver Diseases; Digestive System Diseases; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Poisoning

Intervention Hierarchy (Ancestors)

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

Study Officials

• Muhammad Irfan Jamil

  Lahore General Hospital, Lahore

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 12, 2025
• Study Start: January 15, 2025
• Primary Completion: July 15, 2025
• Study Completion: July 15, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)