Clinical trial NCT01575847: Adduct Dipstick for Diagnosis of Acetaminophen Toxicity
Official title: Adduct Dipstick for Diagnosis of Acetaminophen Toxicity
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetaminophen Toxicity
Keywords: Acetaminophen
Acetaminophen Toxicity
Lead sponsor: Arkansas Children's Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: University of Arkansas
name: University of Texas Southwestern Medical Center
name: Virginia Commonwealth University
name: Medical University of South Carolina
name: University of Michigan
name: University of California, San Francisco
name: University of Washington
First posted: 2012-04-12
Enrollment: 120
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
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).

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.


Eligibility 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.

Primary outcomes:
measure: Accuracy of dipstick compared to HPLC-EC Method for detecting assays
timeFrame: Each subject will have one sample taken but chart review could last entire hospitalization expected average of 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock
country: United States
facility: University of Arkansas for Medical Sciences/Arkansas Children's Hospital
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Henry Farrar, MD
role: PRINCIPAL_INVESTIGATOR
References: