Ignite Creation Date:
2024-05-05 @ 11:53 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00166608
Status:
COMPLETED
Last Update Posted:
2012-04-12
First Post:
2005-09-09
Brief Title:
Cytokines Polymorphisms and Acetaminophen Toxicity
Sponsor:
Arkansas Childrens Hospital Research Institute
Organization:
Arkansas Childrens Hospital Research Institute
Study Overview
Official Title:
Measurement of Nitrotyrosine Adducts and Cytokines in Acetaminophen Overdose Patients
Status:
COMPLETED
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Genotyping assays for polymorphisms in the interleukin 10IL10gene and the inducible nitric oxide synthase iNOS gene will be performed Genotypes will be compared to the severity of toxicity following overdose
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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None