Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
253 participants
OBSERVATIONAL
2009-08-31
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Group A
Subjects receiving recommended doses of acetaminophen in the hospital. 140 Subjects
No interventions assigned to this group
Group B
Healthy Volunteers - No acetaminophen exposure within 14 days of enrollment 23 Subjects
No interventions assigned to this group
Group C
Acetaminophen Overdose Subjects - Hospitalized 90 Subjects
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
1 Year
18 Years
ALL
Yes
Sponsors
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National Institutes of Health (NIH)
NIH
Arkansas Children's Hospital Research Institute
OTHER
Responsible Party
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Principal Investigators
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Laura P James, MD
Role: PRINCIPAL_INVESTIGATOR
Arkansas Children's Hospital Research Institute
Locations
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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
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States
Akron Children's Research Center
Akron, Ohio, United States
University of Toledo Health Science Center
Toledo, Ohio, United States
Cook's Children's Health System
Fort Worth, Texas, United States
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, United States
Countries
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Other Identifiers
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1 R01 DK081406-01A1 - NIH
Identifier Type: -
Identifier Source: secondary_id