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Cytokines Polymorphisms and Acetaminophen Toxicity

NCT ID: NCT00166608

Last Updated: 2012-04-12

Study Results

Results pending

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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Recruitment Status

COMPLETED

Total Enrollment

111 participants

Study Classification

OBSERVATIONAL

Study Start Date

2002-12-31

Study Completion Date

2007-09-30

Brief Summary

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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.

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Detailed Description

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It was recently reported that IL-10 is protective in Acetaminophen (APAP) toxicity and it down-regulates iNOS production. In an ongoing Pediatric Pharmacology Research Unit (PPRU) Network study, plasma IL-10 levels were higher in patients that developed significant toxicity, as compared to those with minimal hepatic transaminase elevations. In these patients IL-10 elevation is likely a compensatory response to hepatic injury. To further examine the relationship of IL-10 and iNOS in the APAP overdose patients, we will examine genetic variability in the promotor regions of iNOS and IL-10 in patients with APAP overdose. Data from the literature indicate the polymorphisms in the promotor regions of iNOS and IL-10 influence the severity and expression of various diseases. In addition to genotyping for iNOS and IL10 promotor region polymorphisms, plasma levels of nitrotyrosine and IL-10 will be measured in overdose patients.

Blood samples will be obtained from study patients for the analysis of inflammatory cytokines and nitrotyrosine. Blood samples will be obtained at the time of blood sampling for the routine clinical management of the APAP overdose patient. Patients who are hospitalized will have study blood samples drawn at the time daily blood samples are obtained. The sampling will continue daily until the patient is discharged. In addition to blood sampling the following data will be collected: age, gender, race, circumstances of the ingestion, dose of the ingestion, treatment for the ingestion, concomitant therapy, medical history and cigarette use.

Conditions

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Drug Toxicity

Study Design

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Study Time Perspective

PROSPECTIVE

Interventions

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Blood sampling

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Patients who are unable to tolerate study procedures.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Arkansas Children's Hospital Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Arkansas Children's Hospital Research Institute

Principal Investigators

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Laura James, M.D.

Role: PRINCIPAL_INVESTIGATOR

Arkansas Children's Hospital Research Institute

Locations

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Arkansas Children's Hospital

Little Rock, Arkansas, United States

Site Status

Kosair Children's Hospital

Louisville, Kentucky, United States

Site Status

Children's Hospital of Michigan

Detroit, Michigan, United States

Site Status

Children's Mercy Hospital

Kansas City, Missouri, United States

Site Status

University of North Carolina--Chapel Hill

Chapel Hill, North Carolina, United States

Site Status

Rainbow Babies & Children's Hospital

Cleveland, Ohio, United States

Site Status

Texas Children's Hospital

Houston, Texas, United States

Site Status

Countries

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United States

References

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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.

Reference Type BACKGROUND
PMID: 16172181 (View on PubMed)

Other Identifiers

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PPRU-10369s

Identifier Type: -

Identifier Source: org_study_id

NCT00147407

Identifier Type: -

Identifier Source: nct_alias

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