Acute Liver FailureNCT06872372
Role of N-Acetylcysteine in Non-Acetaminophen-Induced Acute Liver Failure
A study testing N-Acetylcysteine (NAC) Treatment and Standard supportive care in people with Acute Liver Failure and Drug-Induced Liver Injury, run by Lahore General Hospital at 1 site in Pakistan.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Acute Liver Failure, Drug-Induced Liver Injury
- What is being tested?
- N-Acetylcysteine (NAC) Treatment and Standard supportive care
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 62 participants
- Where
- 1 sitePakistan
- Study dates
- 15 Jan 2025to 15 Jul 2025
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Pakistan1 site
Lahore General Hospital, Lahore
Lahore, Punjab Province, 54000
About this study
Official title: Role of N-Acetylcysteine in Non-Acetaminophen-Induced Acute Liver Failure: a Randomized Controlled Trial
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.
Read the detailed description
This study was conducted with the necessary ethical considerations. Ethical approval was obtained from the ethical review board of the institution. Informed consent was obtained from each participant or their legal guardians before enrollment in the study. Participants were selected based on predefined selection criteria. Comprehensive baseline data were gathered from all participants, including demographic information (age, gender), detailed medical history (duration of symptoms, known etiologies), and past medical conditions (comorbidities, chronic viral hepatitis, tuberculosis).
Baseline investigations included a comprehensive set of laboratory tests: bilirubin, albumin, International Normalized Ratio (INR), Aspartate Aminotransferase, Alanine Aminotransferase, complete blood count, renal function tests, electrolytes, blood glucose, and viral serology (Hepatitis B Surface Antigen, Hepatitis B Core Immunoglobulin M, Hepatitis A Virus Immunoglobulin M, Hepatitis C Virus Antibody), along with additional tests as indicated by clinical suspicion (e.g., autoimmune markers, Wilson profile, iron profile, Herpes Simplex Virus / Cytomegalovirus / Epstein-Barr Virus serology). All patients were admitted to the Intensive Care Unit. Participants were randomly assigned to either the NAC treatment group or the control group using the lottery method.
NAC Group: NAC was administered 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. It was continued for 3 days.
Control Group: Participants received the standard supportive care protocol for ALF.
Throughout the study, participants received standard supportive care treatment, which remained consistent in both groups. This care included measures to prevent hypoglycemia, the administration of broad-spectrum prophylactic antimicrobials, proton pump inhibitors for stress-related ulcers, and maintenance of fluid and electrolyte balance. In cases of advanced hepatic encephalopathy, anti-encephalopathy measures were provided. Fresh frozen plasma was administered to patients experiencing spontaneous bleeding. Blood and urine cultures were obtained in cases where sepsis was suspected, and treatment was administered based on sensitivity. Patients were followed for up to 28 days to assess outcomes. Data were collected using a data collection proforma.
- Conditions
- Acute Liver Failure, Drug-Induced Liver Injury
- Being tested
- N-Acetylcysteine (NAC) Treatment, Standard supportive care
- Keywords
- Non-Acetaminophen-Induced Liver Injury, N-Acetylcysteine (NAC), Drug-Induced Hepatotoxicity
- Medical subject headings
- Liver Failure, Acute, Chemical and Drug Induced Liver Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
N-Acetylcysteine (NAC) TreatmentDrug
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.
Standard supportive careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: N-Acetylcysteine (NAC) Treatment |
| Control Group | Placebo comparator | Participants in this group received only standard supportive care, without N-Acetylcysteine (NAC). Receives: Other: Standard supportive care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 28 days post-enrollment
Mortality Rate
Proportion of patients who die within 28 days after enrollment in the study.
Measured: 28 days post-enrollment
Secondary outcomes (1)
Length of Hospital Stay
The total number of days each participant hospitalized from admission to discharge or death.
Measured: Through study completion, an average of 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2025
- Study start15 Jan 2025
- Primary completion15 Jul 2025 (estimated)
- Study completion15 Jul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Liver FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 62 participants (actual)
Sponsor and investigators
- Lead sponsor
- Lahore General Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Muhammad Irfan Jamil, Lahore General Hospital
- Investigators
- Muhammad Irfan Jamil, Principal investigator, Lahore General Hospital, Lahore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06872372
- Sponsor's protocol ID
- LahoreGeneralH3
- Status last verified
- Mar 2025
- First submitted
- 27 Feb 2025
- Last updated
- 12 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No