Acetaminophen Biomarkers

Arkansas Children's Hospital Research Institute

Status: Unknown

Conditions: Acetaminophen Toxicity

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT01005173

1R01DK081406-01A1

1 R01 DK081406-01A1 - NIH

Details and patient eligibility

About

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.

Enrollment: 253 estimated patients

Sex: All

Ages: 1 to 18 years old

Volunteers: Accepts Healthy Volunteers

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 design

253 participants in 3 patient groups

Group A

Description:

Subjects receiving recommended doses of acetaminophen in the hospital. 140 Subjects

Group B

Description:

Healthy Volunteers - No acetaminophen exposure within 14 days of enrollment 23 Subjects

Group C

Description:

Acetaminophen Overdose Subjects - Hospitalized 90 Subjects