Adduct Dipstick for Diagnosis of Acetaminophen Toxicity

Completed

Conditions studied: Acetaminophen Toxicity

In brief

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.

Key facts

Study ID

NCT01575847

Run by

Arkansas Children's Hospital Research Institute

People needed

120

Starts

2011-08-01

Expected to finish

2016-09-01

Last updated by the study team

2017-01-04

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Subject is 12-18 years of age.
• Subject has an APAP level ordered as part of clinical management.

You may not qualify if…

• 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.

Where it is running

• University of Arkansas for Medical Sciences/Arkansas Children's Hospital — Little Rock, Arkansas, United States

Full record on ClinicalTrials.gov

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