Acetaminophen Toxicity
Conditions
Keywords
Acetaminophen, APAP
Brief 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.
Interventions
None listed
Sponsors
National Institutes of Health (NIH)
Arkansas Children's Hospital Research Institute
Study design
Observational model
CASE_CONTROL
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
1 Years to 18 Years
Healthy volunteers
Yes
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
Countries
United States
Outcome results
None listed