Cytokines Polymorphisms and Acetaminophen Toxicity

This study has been completed.
Sponsor:
Collaborator:
Information provided by:
Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT00166608
First received: September 9, 2005
Last updated: April 10, 2012
Last verified: April 2012

September 9, 2005
April 10, 2012
December 2002
May 2007   (final data collection date for primary outcome measure)
To investigate the relationships of cytokines and toxicity in acetaminophen overdose, blood sampleswere collected from patients following acute ingestions of acetaminophen.
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Complete list of historical versions of study NCT00166608 on ClinicalTrials.gov Archive Site
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Cytokines Polymorphisms and Acetaminophen Toxicity
Measurement of Nitrotyrosine Adducts and Cytokines in Acetaminophen Overdose Patients

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.

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.

Observational
Time Perspective: Prospective
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Probability Sample

Publication Attached

Drug Toxicity
Procedure: Blood sampling
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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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
111
September 2007
May 2007   (final data collection date for primary outcome measure)

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.
Both
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No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00166608
PPRU-10369s
No
Laura James, M.D., Arkansas Children's Hospital Research Institute
Arkansas Children's Hospital Research Institute
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Principal Investigator: Laura James, M.D. Arkansas Children's Hospital Research Institute
Arkansas Children's Hospital Research Institute
April 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP