Adduct Dipstick for Diagnosis of Acetaminophen Toxicity

Acetaminophen Toxicity Clinical Trial

Official title:

Adduct Dipstick for Diagnosis of Acetaminophen Toxicity

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01575847
• Other study ID #: Acetaminophen Adduct Dipstick
• Status: Completed
• Phase: N/A
• First received: November 23, 2011
• Last updated: January 3, 2017
• Start date: August 2011
• Est. completion date: September 2016

Study information

• Verified date: January 2017
• Source: Arkansas Children's Hospital Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: September 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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.

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Acetaminophen Toxicity

Locations

Country	Name	City	State
United States	University of Arkansas for Medical Sciences/Arkansas Children's Hospital	Little Rock	Arkansas

Sponsors (8)

Lead Sponsor	Collaborator
Arkansas Children's Hospital Research Institute	Medical University of South Carolina, University of Arkansas, University of California, San Francisco, University of Michigan, University of Texas Southwestern Medical Center, University of Washington, Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Accuracy of dipstick compared to HPLC-EC Method for detecting assays	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	Each subject will have one sample taken but chart review could last entire hospitalization expected average of 2 weeks	No