Clinical trial NCT01005173: Acetaminophen Biomarkers
Official title: Identification of New Mechanistic Biomarkers of Adverse Response to Acetaminophen
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Acetaminophen Toxicity
Keywords: Acetaminophen
APAP
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
First posted: 2009-10-30
Enrollment: 253
Sex: ALL
Minimum age (years): 1
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children Ages 1-18

Group A - Hospitalized receiving acetaminophen

Group B - Healthy volunteers - no acetaminophen within 14 days

Group C - Acetaminophen Overdose - Hospitalized

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.


Eligibility criteria: 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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: Arkansas Children's Hospital
state: Arkansas
city: Washington
country: United States
facility: Children's National Medical Center
state: District of Columbia
city: Louisville
country: United States
facility: Kosair Charities Pediatric Clinical Research Unit University of Louisville
state: Kentucky
city: Kansas City
country: United States
facility: Children's Mercy Hospitals and Clinics
state: Missouri
city: Akron
country: United States
facility: Akron Children's Research Center
state: Ohio
city: Toledo
country: United States
facility: University of Toledo Health Science Center
state: Ohio
city: Fort Worth
country: United States
facility: Cook's Children's Health System
state: Texas
city: Houston
country: United States
facility: Baylor College of Medicine - Texas Children's Hospital
state: Texas
Study officials:
affiliation: Arkansas Children's Hospital Research Institute
name: Laura P James, MD
role: PRINCIPAL_INVESTIGATOR
References: