Clinical Trials Logo
  1. Home
  2. Drug Toxicity
  3. NCT00166608
  4. Details
NCT00166608 Clinical Trial

Cytokines Polymorphisms and Acetaminophen Toxicity

Drug Toxicity Clinical Trial

Official title:
Measurement of Nitrotyrosine Adducts and Cytokines in Acetaminophen Overdose Patients

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00166608
Other study ID # PPRU-10369s
Secondary ID
Status Completed
Phase N/A
First received September 9, 2005
Last updated April 10, 2012
Start date December 2002
Est. completion date September 2007

Study information
Verified date April 2012
Source Arkansas Children's Hospital Research Institute
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

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.

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.

Other known NCT identifiers
  • NCT00147407

Recruitment information / eligibility
Status Completed
Enrollment 111
Est. completion date September 2007
Est. primary completion date May 2007
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility Inclusion Criteria:

- Males and females of any age admitted to a participating site for acetaminophen overdose (acute or chronic).

Exclusion Criteria:

- Patients who are unable to tolerate study procedures.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Procedure:
• Blood sampling

Locations
Country Name City State
United States University of North Carolina--Chapel Hill Chapel Hill North Carolina
United States Rainbow Babies & Children's Hospital Cleveland Ohio
United States Children's Hospital of Michigan Detroit Michigan
United States Texas Children's Hospital Houston Texas
United States Children's Mercy Hospital Kansas City Missouri
United States Arkansas Children's Hospital Little Rock Arkansas
United States Kosair Children's Hospital Louisville Kentucky

Sponsors (2)
Lead Sponsor Collaborator
Arkansas Children's Hospital Research Institute Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Country where clinical trial is conducted

United States, 

References & Publications (1)

James LP, Simpson PM, Farrar HC, Kearns GL, Wasserman GS, Blumer JL, Reed MD, Sullivan JE, Hinson JA. Cytokines and toxicity in acetaminophen overdose. J Clin Pharmacol. 2005 Oct;45(10):1165-71. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To investigate the relationships of cytokines and toxicity in acetaminophen overdose, blood sampleswere collected from patients following acute ingestions of acetaminophen.
See also
  Status Clinical Trial Phase
Completed NCT03265613 - Safety and Efficacy of Expanded Allogeneic AD-MSCs in Patients With Moderate to Severe Psoriasis Phase 1/Phase 2
Recruiting NCT04696081 - Atrial Fibrillation in Active Cancer Patients
Active, not recruiting NCT03651778 - GHB Poisoning and Poisoning Induced by Others
Completed NCT04120233 - MW151-101: First-in-human Study of MW151 Phase 1
Recruiting NCT01965275 - High-Dose,Pulsatile Erlotinib/Gefitinib for Advanced NSCLC Patients After Failure of Standard Dose EGFR-TKIs Phase 2
Completed NCT01614080 - Outcome of Patients Treated by iv Rt-PA for Cerebral Ischaemia According to the Ratio Sc-tPA/Tc-tPA N/A
Recruiting NCT04659343 - TDM for Optimized Outcome in Patients With mRCC.
Completed NCT02864030 - PAINTER: Polymorphism And INcidence of Toxicity in ERibulin Treatment Phase 4
Completed NCT01135680 - Double-Blind Randomized Crossover Trial to Access Electrocardiogram Effects of HPN-100 Phase 1
Completed NCT03947034 - Monitoring the Hyperammonaemia:TOXicity of Drugs (AmmoTOX)
Recruiting NCT03885388 - Combination of Methotrexate(MTX) and Actinomycin(ACTD) in the Low Risk Gestational Trophoblastic Neoplasma （GTN） Patients With Score of 5-6 Phase 2/Phase 3
Completed NCT00491595 - Phase I Clinical Study of Soy Isoflavones in Healthy, Post-Menopausal Women Phase 1
Recruiting NCT03469063 - Impact of AferBio® on Quality of Life and Chemotherapy Toxicity in Lung Cancer Patients N/A
Not yet recruiting NCT04671589 - Antidote for Valproic Acid Toxicity: a New Indication for Meropenem Antibiotic. Phase 4
Completed NCT03280368 - Adherence and Coagulation Assays in Dabigatran-treated Patients With Atrial Fibrillation
Withdrawn NCT01374061 - Pre Hospital Evaluation of Video Laryngoscopy Phase 4
Completed NCT03994302 - Monitoring the Antiphospholipid Syndrome:TOXicity of Drugs (APSTOX)
Completed NCT03392311 - Efficacy and Safety of AD-MSCs Plus Calpocitriol Ointment in Patients With Moderate to Severe Psoriasis Phase 1/Phase 2
Terminated NCT00090844 - Triptorelin for Preserving Ovarian Function in Premenopausal Women Receiving Chemotherapy for Early-Stage Breast Cancer Phase 2
Terminated NCT00213642 - Tc-99m Renography and Cisplatin-induced Nephrotoxicity N/A

External Links