UnknownNot Applicable

Acetaminophen Biomarkers

United States253 participantsStarted 2009-08

Plain-language summary

This study is a non-intervention, multicenter study to address biomarkers of acetaminophen toxicity in children. Specifically, the study will examine acetaminophen (APAP) protein adducts and markers of liver injury in the blood samples of hospitalized children and adolescents who are receiving standard doses of acetaminophen, and children and adolescents who are status post acetaminophen overdose. Ultimately, the data generated from this study will be used to establish second generation biomarkers of acetaminophen toxicity, based on specific adduct proteins, which can be used in future risk assessment studies of children receiving acetaminophen.

Who can participate

Age range1 Year – 18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: Group A: * Children ages 1-18 inclusive * Hospitalized children who are likely to receive or are receiving recommended doses of APAP Group B: * Children ages 1-18 inclusive * Children with no APAP use in the past 14 days Group C: * Children ages 1-18 inclusive * Hospitalized from an acute overdose of APAP * Time of APAP overdose is known or can be estimated within a two hour window Exclusion Criteria: Group A: * Acute or chronic APAP overdose within 14 days * Known history of liver disease or dysfunction Group B: * APAP within the last 14 days * Known history of liver disease or dysfunction Group C: * Chronic overdoses of APAP, defined as multiple time point ingestions of APAP * History of previous APAP overdose * Known pre-existing liver disease

Trial details

NCT IDNCT01005173

SponsorArkansas Children's Hospital Research Institute

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2018-06

View on ClinicalTrials.gov More Acetaminophen Toxicity trials