Trial reportHepatology (Baltimore, Md.)2013
Intravenous N-acetylcysteine in pediatric patients with nonacetaminophen acute liver failure: a placebo-controlled clinical trial.
Trial report in Hepatology (Baltimore, Md.), 2013. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to 2 registered trials, which are not on this map. Cited by 68 papers, 8 of them syntheses that pooled it.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
A Phase 2 Trial of N-Acetylcysteine in Biliary Atresia After Kasai Portoenterostomy
A Phase 1 Trial of Tolerability of Enteral N-Acetylcysteine in Infants
Who cites it
68 citing papers in PubMed, 8 syntheses or guidelines pooled it, 177 citations in OpenAlex.
- Phenotype and Long-Term Outcome in Recurrent Paediatric Acute Liver Failure: Systematic Review and Individual Participant Data Analysis.Liver international : official journal of the International Association for the Study of the Liver · 2025Pooled it
- Chinese guideline for the diagnosis and treatment of drug-induced liver injury: an update.Hepatology international · 2024Guideline
- [Chinese guideline for diagnosis and management of drug-induced liver injury (2023 version)].Zhonghua gan zang bing za zhi = Zhonghua ganzangbing zazhi = Chinese journal of hepatology · 2023Guideline
- Therapeutic Management of Idiosyncratic Drug-Induced Liver Injury and Acetaminophen Hepatotoxicity in the Paediatric Population: A Systematic Review.Drug safety · 2022Pooled it
- N-Acetylcysteine for Preventing Acetaminophen-Induced Liver Injury: A Comprehensive Review.Frontiers in pharmacology · 2022Pooled it
- N-acetylcysteine for non-paracetamol (acetaminophen)-related acute liver failure.The Cochrane database of systematic reviews · 2020Pooled it
- N-acetylcysteine for non-paracetamol drug-induced liver injury: a systematic review.British journal of clinical pharmacology · 2016Pooled it
- Current and future directions in the treatment and prevention of drug-induced liver injury: a systematic review.Expert review of gastroenterology & hepatology · 2016Pooled it
- A phase 2 trial of short-term intravenous N-acetylcysteine in biliary atresia after Kasai portoenterostomy.Hepatology communications · 2025Trial
- Trial
- Role of N-acetylcysteine treatment in non-acetaminophen-induced acute liver failure: A prospective study.Saudi journal of gastroenterology : official journal of the Saudi Gastroenterology AssociationTrial
- Pathomechanism of Fever-Induced Liver Failure in NBAS Deficiency and Treatment Effect of NAC-Observations In Vitro and In Vivo.Liver international : official journal of the International Association for the Study of the Liver · 2026Article
- Successful Heat Stroke-Induced Pediatric Acute Liver Failure Treatment With N-Acetylcysteine Case Report.Critical care explorations · 2026Article
- Antiseizure Treatments and Liver Injury: Expect (and Prevent) the Unexpected.Epilepsy currents · 2026Review
- Re-exploration of the pharmacotherapeutic strategy for drug-induced liver injury: a narrative review.Frontiers in medicine · 2026Review
- Understanding antituberculosis drug-induced hepatotoxicity: Risk factors and effective management strategies in the pediatric population.World journal of clinical pediatrics · 2025Review
- Hepatic Form of Dihydrolipoamide Dehydrogenase Deficiency (DLDD): Phenotypic Spectrum, Laboratory Findings, and Therapeutic Approaches in 52 Patients.Journal of inherited metabolic disease · 2025Article
- Drug-induced liver injury. Part I: Classification, diagnosis and treatment.Clinical and experimental hepatology · 2025Review
- A new opportunity for N-acetylcysteine. An outline of its classic antioxidant effects and its pharmacological potential as an epigenetic modulator in liver diseases treatment.Naunyn-Schmiedeberg's archives of pharmacology · 2025Review
- Drug-Induced Liver Injury-Pharmacological Spectrum Among Children.International journal of molecular sciences · 2025Review
8 more citing papers are in PubMed but not listed here.
Corrections and comments
- Commented on by
Authors and funding
26 authors at 20 institutions in 3 countries.
Funding
Abstract
unlabelledN-acetylcysteine (NAC) was found to improve transplantation-free survival in only those adults with nonacetaminophen (non-APAP) acute liver failure (ALF) and grade 1-2 hepatic encephalopathy (HE). Because non-APAP ALF differs significantly between children and adults, the Pediatric Acute Liver Failure (PALF) Study Group evaluated NAC in non-APAP PALF. Children from birth through age 17 years with non-APAP ALF enrolled in the PALF registry were eligible to enter an adaptively allocated, doubly masked, placebo-controlled trial using a continuous intravenous infusion of NAC (150 mg/kg/day in 5% dextrose in water [D5W]) or placebo (D5W) for up to 7 days. The primary outcome was 1-year survival. Secondary outcomes included liver transplantation-free survival, liver transplantation (LTx), length of intensive care unit (ICU) and hospital stays, organ system failure, and maximum HE score. A total of 184 participants were enrolled in the trial with 92 in each arm. The 1-year survival did not differ significantly (P = 0.19) between the NAC (73%) and placebo (82%) treatment groups. The 1-year LTx-free survival was significantly lower (P = 0.03) in those who received NAC (35%) than those who received placebo (53%), particularly, but not significantly so, among those less than 2 years old with HE grade 0-1 (NAC 25%; placebo 60%; P = 0.0493). There were no significant differences between treatment arms for hospital or ICU length of stay, organ systems failing, or highest recorded grade of HE.
conclusionNAC did not improve 1-year survival in non-APAP PALF. One-year LTx-free survival was significantly lower with NAC, particularly among those <2 years old. These results do not support broad use of NAC in non-APAP PALF and emphasizes the importance of conducting controlled pediatric drug trials, regardless of results in adults.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.