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Adduct Dipstick for Diagnosis of Acetaminophen Toxicity

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ClinicalTrials.gov Identifier: NCT01575847
Recruitment Status : Completed
First Posted : April 12, 2012
Last Update Posted : January 4, 2017
Sponsor:
Collaborators:
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
Information provided by (Responsible Party):
Arkansas Children's Hospital Research Institute

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.

Condition or disease
Acetaminophen Toxicity

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Study Type : Observational
Estimated Enrollment : 120 participants
Time Perspective: Prospective
Official Title: Adduct Dipstick for Diagnosis of Acetaminophen Toxicity
Study Start Date : August 2011
Actual Primary Completion Date : December 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine


Group/Cohort
Part I

Part 1 will be a feasibility study conducted in the Emergency Department at UAMS and ACH. This Part will test the research use dipsticks and dipstick testing kit in subjects that are having APAP levels obtained as part of their medical evaluation.

Part 1 20 subjects

Part I

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

Part 2

Part 2 will be a non-intervention study in adults presenting to hepatology centers participating in the Acute Liver Failure Study Group (ALFSG). The dipstick will be tested in these subjects and the results will be compared to the HPLC-EC measurement of APAP protein adducts. The results of the dipstick testing will not be used for diagnosis or clinical decision-making.

Part 2 100 subjects

Part 2

Inclusion Criteria:

Subject is 18 years of age or older. Subject is enrolled in the ALFSG registry.

Exclusion Criteria:

None.




Primary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
Acetaminophen Adduct Samples


Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Part 1 - Arkansas Children's Hospital ER

Part 2 - adults presenting to hepatology centers participating in the Acute Liver Failure Study Group (ALFSG).

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01575847


Locations
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United States, Arkansas
University of Arkansas for Medical Sciences/Arkansas Children's Hospital
Little Rock, Arkansas, United States, 72202
Sponsors and Collaborators
Arkansas Children's Hospital Research Institute
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
Investigators
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Principal Investigator: Henry Farrar, MD University of Arkansas

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Responsible Party: Arkansas Children's Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01575847     History of Changes
Other Study ID Numbers: Acetaminophen Adduct Dipstick
First Posted: April 12, 2012    Key Record Dates
Last Update Posted: January 4, 2017
Last Verified: January 2017
Keywords provided by Arkansas Children's Hospital Research Institute:
Acetaminophen
Acetaminophen Toxicity
Additional relevant MeSH terms:
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Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics