Measurement of Nitrotyrosine and Cytokines in Acetaminophen Overdose Patients
Information source: National Institute of Child Health and Human Development (NICHD)
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Liver Dysfunction
Intervention: Blood Sampling (Procedure)
Phase: N/A
Status: Recruiting
Sponsored by: National Institute of Child Health and Human Development (NICHD) Official(s) and/or principal investigator(s):
Laura James, M.D., Principal Investigator, Affiliation: Arkansas Children's Hospital Research Institute
Summary
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.
Clinical Details
Official title: Measurement of Nitrotyrosine and Cytokines in Acetaminophen Overdose Patients
Study design: Natural History, Cross-Sectional, Defined Population, Retrospective/Prospective Study
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
Minimum age: N/A.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Arkansas Children's Hospital, Little Rock, Arkansas 72202, United States; Recruiting
Lee Howard, RN, CCRC, Phone: 501-364-6990
Laura James, M.D., Principal Investigator
Kosair Children's Hospital, Louisville, Kentucky 40202, United States; Recruiting
Elizabeth McDowell, RN, Phone: 502-629-5606
Janice Sullivan, M.D., Principal Investigator
Children's Hospital of Michigan, Detroit, Michigan 48201, United States; Recruiting
Melissa Hobbs, Phone: 313-966-0488
Suzanne White, M.D., Principal Investigator
Children's Mercy Hospital, Kansas City, Missouri 64108, United States; Recruiting
Krista Wright, LPN, Phone: 816-234-1618
Gary Wasserman, M.D., Principal Investigator
University of North Carolina- Chapel Hill, Chapel Hill, North Carolina 27599, United States; Recruiting
Claudia Christy, RN, MSN, Phone: 919-966-1814
Brad Harris, M.D., Principal Investigator
Rainbow Babies and Children's Hospital, Cleveland, Ohio 44106, United States; Recruiting
Jolee Kalic, Phone: 216-844-3681
Jeffrey Blumer, M.D., Principal Investigator
Texas Children's Hospital, Houston, Texas 77030, United States; Recruiting
Karen Jones, RN, Phone: 832-824-4209
Charles G. Macias, M.D., Principal Investigator
Additional Information
Pediatric Pharmacology Research Unit Website
Starting date: May 2000
Last updated: June 28, 2007
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