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Sponsors and Collaborators: |
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) Pediatric Pharmacology Research Unit (PPRU) |
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Information provided by: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
ClinicalTrials.gov Identifier: | NCT00147407 |
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 |
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Liver Dysfunction |
Procedure: Blood Sampling |
Study Type: | Observational |
Official Title: | Measurement of Nitrotyrosine and Cytokines in Acetaminophen Overdose Patients |
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) |
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.
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Principal Investigator: | Laura James, M.D. | Arkansas Children's Hospital Research Institute |
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 |
acetaminophen toxicity liver dysfunction tylenol overdose |
Liver Diseases Overdose Digestive System Diseases |
Poisoning Disorders of Environmental Origin Acetaminophen |
Sensory System Agents Analgesics, Non-Narcotic Therapeutic Uses Physiological Effects of Drugs |
Peripheral Nervous System Agents Analgesics Central Nervous System Agents Pharmacologic Actions |