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Measurement of Nitrotyrosine and Cytokines in Acetaminophen Overdose Patients
This study has been completed.
Sponsors and Collaborators: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Pediatric Pharmacology Research Unit (PPRU)
Information provided by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
ClinicalTrials.gov Identifier: NCT00147407
  Purpose

The study will examine all levels of cytokines and nitrotyrosine in patients with acetaminophen overdose. Comparisons will be made between cytokine levels and nitrotyrosine levels and the severity of the liver injury.


Condition Intervention
Liver Dysfunction
Procedure: Blood Sampling

Drug Information available for: Acetaminophen
U.S. FDA Resources
Study Type: Observational
Official Title: Measurement of Nitrotyrosine and Cytokines in Acetaminophen Overdose Patients

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

Estimated Enrollment: 200
Study Start Date: May 2000
Study Completion Date: September 2007
Primary Completion Date: May 2007 (Final data collection date for primary outcome measure)
Detailed Description:

The data obtained from this study will provide the framework for understanding the role of inflammation in the mediation of acetaminophen toxicity in man. Time profiles for inflammatory mediators and correlations between hepatoxicity and the presence of nitrotyrosine and cytokines in plasma will be generated. This data is a prerequisite for the development of new therapies that would inhibit the formation of key inflammatory mediators in acetaminophen toxicity. Of particular interest is the development of therapies that would be effective beyond the timepoint for which NAC is traditionally thought to be of greatest benefit. Patients who would benefit from such therapies include children who are victims of chronic acetaminophen poisoning with therapeutic intent, and patients who present late (i.e., greater than 16 hours after acetaminophen overdose) for medical evaluation following acetaminophen overdose. By understanding the role of inflammatory processes in the development of toxicity, novel therapies may be developed that will improve the management and survival of the complicated acetaminophen overdose patient.

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 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: NCT00147407

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 and Children's Hospital
Cleveland, Ohio, United States, 44106
United States, Texas
Texas Children's Hospital
Houston, Texas, United States, 77030
Sponsors and Collaborators
Pediatric Pharmacology Research Unit (PPRU)
Investigators
Principal Investigator: Laura James, M.D. Arkansas Children's Hospital Research Institute
  More Information

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

Study ID Numbers: PPRU-10368
Study First Received: September 2, 2005
Last Updated: February 11, 2008
ClinicalTrials.gov Identifier: NCT00147407  
Health Authority: United States: Federal Government

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

Study placed in the following topic categories:
Liver Diseases
Overdose
Digestive System Diseases
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 January 16, 2009