Acetaminophen Toxicity
Conditions
Keywords
Acetaminophen, Acetaminophen Toxicity
Brief summary
This study is a non-intervention, clinical study to test research use only APAP protein adducts dipsticks in human blood samples. The study will be conducted in two phases. In phase 1, the research use only dipsticks and dipstick testing components will be tested for feasibility in the emergency department at UAMS. Patients will be enrolled that are having an acetaminophen level obtained as part of their medical evaluation. In phase 2, the research use only dipsticks will be tested in centers that participate in the Acute Liver Failure Study Group (ALFSG), a clinical research network funded by the National Institutes of Diabetes, Digestive and Kidney Diseases (NIDDK). Subjects participating in the clinical registry of the ALFSG will be approached for enrollment. These patients all have the diagnosis of acute liver failure or acute liver injury from a variety of etiologies, including APAP. A single blood sample will be obtained and will be aliquoted for 1) testing by the dipstick and 2) testing by high performance liquid chromatography with electrochemical detection (HPLC-EC) analysis for APAP protein adducts. APAP levels will also be determined from the second aliquot of blood. In both Phase 1 and Phase 2, the dipsticks will be read manually and by dipstick readers by independent testers that are not directly involved in the clinical care of the patients. The results of the two dipstick readings will be recorded, will remain confidential and will not be used in the diagnosis or management of the patient. The results of the dipsticks and HPLC-EC assays will be compared to the final patient diagnoses.
Interventions
None listed
Sponsors
University of Arkansas
University of Texas Southwestern Medical Center
Virginia Commonwealth University
Medical University of South Carolina
University of Michigan
University of California, San Francisco
University of Washington
Arkansas Children's Hospital Research Institute
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Part 1 Inclusion Criteria: * Subject is 12-18 years of age. * Subject has an APAP level ordered as part of clinical management.
Exclusion criteria
* Previous recent history of APAP overdose in the previous 30 days. Part 2 Inclusion Criteria: * Subject is 18 years of age or older. * Subject is enrolled in the ALFSG registry.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of dipstick compared to HPLC-EC Method for detecting assays | Each subject will have one sample taken but chart review could last entire hospitalization expected average of 2 weeks | The primary purpose of this study is to pilot test the study procedures including the dipstick, dipstick instructions, micro-centrifuges, and dipstick readers in a clinical setting and then in the second phase the primary objective will be to compare the results from the dipstick to the currently used method HPLC-EC |
Countries
United States
Outcome results
None listed