Acetaminophen ToxicityNCT00725179
Treatment of Acetaminophen Toxicity With N-acetylcysteine
An observational study of Acetaminophen Toxicity, run by Akron Children's Hospital at 1 site in United States.
Trial summary
Retrospective chart review of patients who received N-acetylcysteine for APAP toxicity to assess length of oral vs IV treatment and overall healthcare costs. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Acetaminophen Toxicity
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 130 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2008to Oct 2008
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Pediatric and adolescent patients with acetaminophen toxicity
Who may be able to join
- Admitted to CHMCA between June 1, 2004 to May 31, 2008 with a qualifying ICD-9 diagnosis code for the following APAP overdose situations; poisoning, accidental, suicide attempt, therapeutic use, assault, and undetermined (965.4, E850.4, E950.0, E935.4, E962.0, E980.0)
- Serum APAP concentrations ≥ 150 g/mL at 4 hours or a serum concentration above the possible hepatotoxic line on the Rumack-Matthew's nomogram if obtained > 4 hours post ingestion
- Between the ages of 0-21 years
Who cannot join
- Serum APAP concentrations are not actually documented
- Patient did not receive oral or IV NAC treatment
- Patient has a preexisting liver disease such as cirrhosis or hepatitis C
- Patient > 21 years of age
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Medical Center of Akron
Akron, Ohio, 44703
About this study
Official title: Treatment of Acetaminophen Toxicity With Intravenous vs Oral N-acetylcysteine: A Retrospective Review
Retrospective chart review of patients who received N-acetylcysteine for APAP toxicity to assess length of oral vs IV treatment and overall healthcare costs.
- Conditions
- Acetaminophen Toxicity
- Keywords
- acetaminophen toxicity, n-acetylcysteine, liver 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 |
|---|---|---|
| 1 | Patients receiving oral NAC treatment | |
| 2 | Patients receiving IV NAC treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of oral vs IV NAC treatment in hours
Measured: From admission to discharge
Secondary outcomes (1)
Overall healthcare costs associated with IV vs Oral NAC treatment
Measured: From admission to discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jul 2008 (estimated)
- Study startAug 2008
- Primary completionSep 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- 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
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Blackford, Akron Children's Hospital
- Investigators
- Martha Blackford, PharmD, Principal investigator, CHMCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00725179
- Sponsor's protocol ID
- APAP & NAC
- Status last verified
- Sep 2011
- First submitted
- 25 Jul 2008
- Last updated
- 9 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Heard KJ. Acetylcysteine for acetaminophen poisoning. N Engl J Med. 2008 Jul 17;359(3):285-92. doi: 10.1056/NEJMct0708278.
PubMed 18635433Culley CM, Krenzelok EP. A clinical and pharmacoeconomic justification for intravenous acetylcysteine: a US perspective. Toxicol Rev. 2005;24(2):131-43. doi: 10.2165/00139709-200524020-00007.
PubMed 16180933Kanter MZ. Comparison of oral and i.v. acetylcysteine in the treatment of acetaminophen poisoning. Am J Health Syst Pharm. 2006 Oct 1;63(19):1821-7. doi: 10.2146/ajhp060050.
PubMed 16990628Blackford MG, Felter T, Gothard MD, Reed MD. Assessment of the clinical use of intravenous and oral N-acetylcysteine in the treatment of acute acetaminophen poisoning in children: a retrospective review. Clin Ther. 2011 Sep;33(9):1322-30. doi: 10.1016/j.clinthera.2011.08.005. Epub 2011 Sep 3.
PubMed 21890206
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acetaminophen Toxicity With Intravenous vs Oral N-acetylcysteine: A Retrospective Review
- ClinicalTrials.gov ID
- NCT00725179
- Acronym / sponsor ID
- APAP & NAC
- Conditions
- Acetaminophen Toxicity
- Keywords
- acetaminophen toxicity, n-acetylcysteine, liver toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- Aug 2008
- Primary completion
- Sep 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 30 Jul 2008 (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.
Retrospective chart review of patients who received N-acetylcysteine for APAP toxicity to assess length of oral vs IV treatment and overall healthcare costs.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | – | –Patients receiving oral NAC treatment |
| 2 | – | –Patients receiving IV NAC treatment |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Pediatric and adolescent patients with acetaminophen toxicity
Key inclusion criteria (3 listed)
- Admitted to CHMCA between June 1, 2004 to May 31, 2008 with a qualifying ICD-9 diagnosis code for the following APAP overdose situations; poisoning, accidental, suicide attempt, therapeutic use, assault, and undetermined (965.4, E850.4, E950.0, E935.4, E962.0, E980.0)
- Serum APAP concentrations ≥ 150 g/mL at 4 hours or a serum concentration above the possible hepatotoxic line on the Rumack-Matthew's nomogram if obtained > 4 hours post ingestion
- Between the ages of 0-21 years
Key exclusion criteria (4 listed)
- Serum APAP concentrations are not actually documented
- Patient did not receive oral or IV NAC treatment
- Patient has a preexisting liver disease such as cirrhosis or hepatitis C
- Patient > 21 years of age
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
Duration of oral vs IV NAC treatment in hours
Time frame: From admission to discharge
1 secondary outcome
Overall healthcare costs associated with IV vs Oral NAC treatment
Time frame: From admission to discharge
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 9 Sep 2011.
- Background: PubMed 18635433Heard KJ. Acetylcysteine for acetaminophen poisoning. N Engl J Med. 2008 Jul 17;359(3):285-92. doi: 10.1056/NEJMct0708278.
- Background: PubMed 16180933Culley CM, Krenzelok EP. A clinical and pharmacoeconomic justification for intravenous acetylcysteine: a US perspective. Toxicol Rev. 2005;24(2):131-43. doi: 10.2165/00139709-200524020-00007.
- Background: PubMed 16990628Kanter MZ. Comparison of oral and i.v. acetylcysteine in the treatment of acetaminophen poisoning. Am J Health Syst Pharm. 2006 Oct 1;63(19):1821-7. doi: 10.2146/ajhp060050.
- Derived from this study: PubMed 21890206Blackford MG, Felter T, Gothard MD, Reed MD. Assessment of the clinical use of intravenous and oral N-acetylcysteine in the treatment of acute acetaminophen poisoning in children: a retrospective review. Clin Ther. 2011 Sep;33(9):1322-30. doi: 10.1016/j.clinthera.2011.08.005. Epub 2011 Sep 3.
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.
Martha Blackford, PharmD principal investigator
CHMCA
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 Akron Children's Hospital 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 3 inclusion and 4 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 9 Sep 2011. 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?
Duration of oral vs IV NAC treatment in hours (time frame: From admission to discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00725179, which also lists 4 linked publications.
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 9 Sep 2011.