Acetaminophen Biomarkers

This study is enrolling participants by invitation only.
Sponsor:
Collaborator:
Information provided by:
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01005173
First received: October 28, 2009
Last updated: November 29, 2012
Last verified: November 2012
  Purpose

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.


Condition
Acetaminophen Toxicity

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Identification of New Mechanistic Biomarkers of Adverse Response to Acetaminophen

Resource links provided by NLM:


Further study details as provided by Arkansas Children's Hospital Research Institute:

Estimated Enrollment: 253
Study Start Date: August 2009
Groups/Cohorts
Group A
Subjects receiving recommended doses of acetaminophen in the hospital. 140 Subjects
Group B
Healthy Volunteers - No acetaminophen exposure within 14 days of enrollment 23 Subjects
Group C
Acetaminophen Overdose Subjects - Hospitalized 90 Subjects

  Eligibility

Ages Eligible for Study:   1 Year to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01005173

Locations
United States, Arkansas
Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
United States, District of Columbia
Children's National Medical Center
Washington DC, District of Columbia, United States, 20010
United States, Kentucky
Kosair Charities Pediatric Clinical Research Unit University of Louisville
Louisville, Kentucky, United States, 40202
United States, Missouri
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, United States, 64108
United States, Ohio
Akron Children's Research Center
Akron, Ohio, United States, 44308
University of Toledo Health Science Center
Toledo, Ohio, United States
United States, Texas
Cook's Children's Health System
Fort Worth, Texas, United States, 76104
Baylor College of Medicine - Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
Investigators
Principal Investigator: Laura P James, MD Arkansas Children's Hospital Research Institute
  More Information

No publications provided

Responsible Party: Laura P. James, M.D., Arkansas Children's Hospital
ClinicalTrials.gov Identifier: NCT01005173     History of Changes
Other Study ID Numbers: 1 R01 DK081406-01A1, 1 R01 DK081406-01A1 - NIH
Study First Received: October 28, 2009
Last Updated: November 29, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Arkansas Children's Hospital Research Institute:
Acetaminophen
APAP

Additional relevant MeSH terms:
Acetaminophen
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 24, 2014