Drug Toxicity Clinical Trial
Official title:
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.
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.
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