Acetaminophen ToxicityNCT01575847
Adduct Dipstick for Diagnosis of Acetaminophen Toxicity
An observational study of Acetaminophen Toxicity, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Acetaminophen Toxicity
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2011to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- Subject is 12-18 years of age.
- Subject has an APAP level ordered as part of clinical management.
- Subject is 18 years of age or older.
- Subject is enrolled in the ALFSG registry.
Who cannot join
- Previous recent history of APAP overdose in the previous 30 days.
- Part 2
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Arkansas for Medical Sciences/Arkansas Children's Hospital
Little Rock, Arkansas, 72202
About this study
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.
- Conditions
- Acetaminophen Toxicity
- Keywords
- Acetaminophen, Acetaminophen Toxicity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Each subject will have one sample taken but chart review could last entire hospitalization expected average of 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2012 (estimated)
- Study startAug 2011
- Primary completionDec 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acetaminophen ToxicityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Arkansas Children's Hospital Research Institute
- Sponsor type
- University, hospital or other
- 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
- Responsible party
- Sponsor
- Investigators
- Henry Farrar, MD, Principal investigator, University of Arkansas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01575847
- Sponsor's protocol ID
- Acetaminophen Adduct Dipstick
- Status last verified
- Jan 2017
- First submitted
- 23 Nov 2011
- Last updated
- 4 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adduct Dipstick for Diagnosis of Acetaminophen Toxicity
- ClinicalTrials.gov ID
- NCT01575847
- Acronym / sponsor ID
- Acetaminophen Adduct Dipstick
- Conditions
- Acetaminophen Toxicity
- Keywords
- Acetaminophen, Acetaminophen Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Arkansas Children's Hospital Research InstituteUniversity, hospital or other
- 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
- Study start
- Aug 2011
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 12 Apr 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (4 listed)
- Subject is 12-18 years of age.
- Subject has an APAP level ordered as part of clinical management.
- Subject is 18 years of age or older.
- Subject is enrolled in the ALFSG registry.
Key exclusion criteria (2 listed)
- Previous recent history of APAP overdose in the previous 30 days.
- Part 2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jan 2017.
Related trials for Acetaminophen Toxicity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henry Farrar, MD principal investigator
University of Arkansas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acetaminophen Toxicity, run by Arkansas Children's Hospital Research Institute at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jan 2017.