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Cytokines Polymorphisms and Acetaminophen Toxicity

This study has been completed.

Sponsored by: National Institute of Child Health and Human Development (NICHD)
Information provided by: National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00166608
  Purpose

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.


Condition Intervention
Drug Toxicity
Procedure: Blood sampling

ChemIDplus related topics:   Acetaminophen   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Prospective
Official Title:   Measurement of Nitrotyrosine Adducts and Cytokines in Acetaminophen Overdose Patients

Further study details as provided by National Institute of Child Health and Human Development (NICHD):

Estimated Enrollment:   200
Study Start Date:   December 2002
Study Completion Date:   September 2007
Primary Completion Date:   May 2007 (Final data collection date for primary outcome measure)

Detailed Description:

It was recently reported that IL-10 is protective in APAP toxicity and it down-regulates iNOS production. In an ongoing 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.

  Eligibility
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

Criteria

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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00166608

Locations
United States, Arkansas
Arkansas Children's Hospital    
      Little Rock, Arkansas, United States, 72202
United States, Kentucky
Kosair Children's Hospital    
      Louisville, Kentucky, United States, 40202
United States, Michigan
Children's Hospital of Michigan    
      Detroit, Michigan, United States, 48201
United States, Missouri
Children's Mercy Hospital    
      Kansas City, Missouri, United States, 64108
United States, North Carolina
University of North Carolina--Chapel Hill    
      Chapel Hill, North Carolina, United States, 27599
United States, Ohio
Rainbow Babies & Children's Hospital    
      Cleveland, Ohio, United States, 44106
United States, Texas
Texas Children's Hospital    
      Houston, Texas, United States, 77030

Sponsors and Collaborators

Investigators
Principal Investigator:     Laura James, M.D.     Arkansas Children's Hospital Research Institute    
  More Information


Pediatric Pharmacology Research Units Website  This link exits the ClinicalTrials.gov site
 

Study ID Numbers:   PPRU-10369s
First Received:   September 9, 2005
Last Updated:   February 20, 2008
ClinicalTrials.gov Identifier:   NCT00166608
Health Authority:   United States: Federal Government

Keywords provided by National Institute of Child Health and Human Development (NICHD):
acetaminophen toxicity  
liver damage  
tylenol overdose  

Study placed in the following topic categories:
Overdose
Drug Toxicity
Poisoning
Disorders of Environmental Origin
Acetaminophen

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

ClinicalTrials.gov processed this record on October 07, 2008




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