Acetaminophen Biomarkers
- Conditions
- Acetaminophen Toxicity
- Registration Number
- NCT01005173
- Lead Sponsor
- Arkansas Children's Hospital Research Institute
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 253
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
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Baylor College of Medicine - Texas Children's Hospital
🇺🇸Houston, Texas, United States
Children's National Medical Center
🇺🇸Washington, District of Columbia, United States
Akron Children's Research Center
🇺🇸Akron, Ohio, United States
Kosair Charities Pediatric Clinical Research Unit University of Louisville
🇺🇸Louisville, Kentucky, United States
Children's Mercy Hospitals and Clinics
🇺🇸Kansas City, Missouri, United States
Arkansas Children's Hospital
🇺🇸Little Rock, Arkansas, United States
University of Toledo Health Science Center
🇺🇸Toledo, Ohio, United States
Cook's Children's Health System
🇺🇸Fort Worth, Texas, United States