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Completed

NCT Number: NCT01575847

Adduct Dipstick for Diagnosis of Acetaminophen Toxicity

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.

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Key information

Age range

12 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Arkansas for Medical Sciences/Arkansas Children's Hospital

Little Rock, Arkansas, 72202, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Accuracy of dipstick compared to HPLC-EC Method for detecting assays

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Arkansas Children's Hospital Research Institute

Other

Collaborators

  • 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

Registry information

Important dates

Study start
2011
Primary completion
2015
Study completion
2016
First posted
Apr 12, 2012
Registry last updated
Jan 4, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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