Acetaminophen Biomarkers

Arkansas Children's Hospital Research Institute253 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

253

Conditions

Acetaminophen Toxicity

Eligibility

Sex: ALLMin age: 1 YearMax age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (8)

Arkansas Children's Hospital

Little Rock, Arkansas, United States

Children's National Medical Center

Washington D.C., District of Columbia, United States

Kosair Charities Pediatric Clinical Research Unit University of Louisville

Louisville, Kentucky, United States

Data from ClinicalTrials.gov

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