NCT00166608

Brief Summary

Genotyping assays for polymorphisms in the interleukin 10(IL10)gene and the inducible nitric oxide synthase (iNOS) gene will be performed. Genotypes will be compared to the severity of toxicity following overdose.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
111

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Dec 2002

Longer than P75 for all trials

Geographic Reach
1 country

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2002

Completed
2.8 years until next milestone

First Submitted

Initial submission to the registry

September 9, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 14, 2005

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2007

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

April 12, 2012

Status Verified

April 1, 2012

Enrollment Period

4.4 years

First QC Date

September 9, 2005

Last Update Submit

April 10, 2012

Conditions

Drug Toxicity

Keywords

acetaminophen toxicityliver damagetylenol overdose

Outcome Measures

Primary Outcomes (1)

  • To investigate the relationships of cytokines and toxicity in acetaminophen overdose, blood sampleswere collected from patients following acute ingestions of acetaminophen.

Interventions

Blood samplingPROCEDURE

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Publication Attached

You may qualify if:

  • Males and females of any age admitted to a participating site for acetaminophen overdose (acute or chronic).

You may not qualify if:

  • Patients who are unable to tolerate study procedures.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Location

Kosair Children's Hospital

Louisville, Kentucky, 40202, United States

Location

Children's Hospital of Michigan

Detroit, Michigan, 48201, United States

Location

Children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

University of North Carolina--Chapel Hill

Chapel Hill, North Carolina, 27599, United States

Location

Rainbow Babies & Children's Hospital

Cleveland, Ohio, 44106, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

Related Publications (1)

  • James LP, Simpson PM, Farrar HC, Kearns GL, Wasserman GS, Blumer JL, Reed MD, Sullivan JE, Hinson JA. Cytokines and toxicity in acetaminophen overdose. J Clin Pharmacol. 2005 Oct;45(10):1165-71. doi: 10.1177/0091270005280296.

    PMID: 16172181BACKGROUND

MeSH Terms

Conditions

Drug-Related Side Effects and Adverse Reactions

Interventions

Blood Specimen Collection

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders

Intervention Hierarchy (Ancestors)

Specimen HandlingClinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisPuncturesSurgical Procedures, OperativeInvestigative Techniques

Study Officials

  • Laura James, M.D.

    Arkansas Children's Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 9, 2005

First Posted

September 14, 2005

Study Start

December 1, 2002

Primary Completion

May 1, 2007

Study Completion

September 1, 2007

Last Updated

April 12, 2012

Record last verified: 2012-04

Locations

US(7)