Cytokines Polymorphisms and Acetaminophen Toxicity

April 10, 2012 updated by: Arkansas Children's Hospital Research Institute

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

111

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Publication Attached

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Arkansas Children's Hospital Research Institute

Collaborators

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

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2002

Primary Completion (Actual)

May 1, 2007

Study Completion (Actual)

September 1, 2007

Study Registration Dates

First Submitted

September 9, 2005

First Submitted That Met QC Criteria

September 9, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

April 12, 2012

Last Update Submitted That Met QC Criteria

April 10, 2012

Last Verified

April 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PPRU-10369s

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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