Acetaminophen ToxicityNCT01465542
Treatment of APAP Toxicity With IV and Oral NAC 2008-2011
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 receive N-acetylcysteine for Acetaminophen(APAP) toxicity to assess length of oral vs. IV treatment and the effect of a Clinical Pharmacology and Toxicology division in the management of APAP ingestions. Read more about this study
- Who is it for?
- Ages 1 month to 21 years
- Conditions the study is for
- Acetaminophen Toxicity
- Type of treatment
- Pill or oral medicine, Injection or infusion
- How many people
- 47 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2011to Nov 2011
- 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 1 month to 21 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Pediatric and adolescent patients with acetaminophen toxicity.
Who may be able to join
- Admitted to CHMCA between June 1, 2008 to June 30, 2011
- 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 concentration above the possible hepatotoxic line on the Rumack-Matthew's nomogram if obtained > 4 hours post ingestion
- Between ages 0-21 years on date of admission
- Acute APAP ingestion
Who cannot join
- Serum APAP concentrations not actually documented
- Did not receive the oral or IV NAC treatment
- Preexisting liver disease such as cirrhosis or hepatitis C
- Patient > 21 years of age on the date of admission
- Chronic APAP ingestion
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Medical Center of Akron
Akron, Ohio, 44308
About this study
Official title: Treatment of Acetaminophen Toxicity With Intravenous vs. Oral N-acetylcysteine: A Retrospective Review
Retrospective chart review of patients who receive N-acetylcysteine for Acetaminophen(APAP) toxicity to assess length of oral vs. IV treatment and the effect of a Clinical Pharmacology and Toxicology division in the management of APAP ingestions.
- Conditions
- Acetaminophen Toxicity
- Keywords
- Acetaminophen Toxicity, Acetaminophen Overdose, 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 |
|---|---|---|
| Oral NAC | Patients receiving oral NAC treatment after an acute acetaminophen ingestion. | |
| IV NAC | Patients receiving IV NAC after an acute Acetaminophen ingestion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Length of NAC treatment in hours
Length of NAC treatment (in hours) for both IV and PO formulations used in patients with APAP toxicity
Measured: Retrospective data collection for patient's hospital admission, max estimated 5days
Secondary outcomes (1)
Pharmacology & Toxicology consults
Documenting whether or not a pharmacology \& toxicology consult was obtained during the patient's hospital admission for APAP toxicity
Measured: Retrospective data collection for length of patient's hospital admission, max estimated 5 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 2011 (estimated)
- Study startJun 2011
- Primary completionAug 2011
- Study completionNov 2011
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
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Akron Children's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martha Blackford, PharmD, Akron Children's Hospital
- Investigators
- Martha Blackford, PharmD, Principal investigator, CHMCA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01465542
- Sponsor's protocol ID
- APAP & NAC 2008-2011
- Status last verified
- Jul 2023
- First submitted
- 31 Oct 2011
- Last updated
- 25 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Dart RC, Erdman AR, Olson KR, Christianson G, Manoguerra AS, Chyka PA, Caravati EM, Wax PM, Keyes DC, Woolf AD, Scharman EJ, Booze LL, Troutman WG; American Association of Poison Control Centers. Acetaminophen poisoning: an evidence-based consensus guideline for out-of-hospital management. Clin Toxicol (Phila). 2006;44(1):1-18. doi: 10.1080/15563650500394571.
PubMed 16496488Kanter 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 16990628Whyte IM, Francis B, Dawson AH. Safety and efficacy of intravenous N-acetylcysteine for acetaminophen overdose: analysis of the Hunter Area Toxicology Service (HATS) database. Curr Med Res Opin. 2007 Oct;23(10):2359-68. doi: 10.1185/030079907X219715.
PubMed 17705945Yarema MC, Johnson DW, Berlin RJ, Sivilotti ML, Nettel-Aguirre A, Brant RF, Spyker DA, Bailey B, Chalut D, Lee JS, Plint AC, Purssell RA, Rutledge T, Seviour CA, Stiell IG, Thompson M, Tyberg J, Dart RC, Rumack BH. Comparison of the 20-hour intravenous and 72-hour oral acetylcysteine protocols for the treatment of acute acetaminophen poisoning. Ann Emerg Med. 2009 Oct;54(4):606-14. doi: 10.1016/j.annemergmed.2009.05.010. Epub 2009 Jun 25.
PubMed 19556028
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2023. 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
- NCT01465542
- Acronym / sponsor ID
- APAP & NAC 2008-2011
- Conditions
- Acetaminophen Toxicity
- Keywords
- Acetaminophen Toxicity, Acetaminophen Overdose, N-acetylcysteine, Liver Toxicity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Akron Children's HospitalUniversity, hospital or other
- Study start
- Jun 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 4 Nov 2011 (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 receive N-acetylcysteine for Acetaminophen(APAP) toxicity to assess length of oral vs. IV treatment and the effect of a Clinical Pharmacology and Toxicology division in the management of APAP ingestions.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Oral NAC | – | –Patients receiving oral NAC treatment after an acute acetaminophen ingestion. |
| IV NAC | – | –Patients receiving IV NAC after an acute Acetaminophen ingestion. |
Who may qualify
- Ages
- 1 month to 21 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Pediatric and adolescent patients with acetaminophen toxicity.
Key inclusion criteria (5 listed)
- Admitted to CHMCA between June 1, 2008 to June 30, 2011
- 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 concentration above the possible hepatotoxic line on the Rumack-Matthew's nomogram if obtained > 4 hours post ingestion
- Between ages 0-21 years on date of admission
- Acute APAP ingestion
Key exclusion criteria (5 listed)
- Serum APAP concentrations not actually documented
- Did not receive the oral or IV NAC treatment
- Preexisting liver disease such as cirrhosis or hepatitis C
- Patient > 21 years of age on the date of admission
- Chronic APAP ingestion
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
Length of NAC treatment in hours
Time frame: Retrospective data collection for patient's hospital admission, max estimated 5days
Length of NAC treatment (in hours) for both IV and PO formulations used in patients with APAP toxicity
1 secondary outcome
Pharmacology & Toxicology consults
Time frame: Retrospective data collection for length of patient's hospital admission, max estimated 5 days
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 25 Jul 2023.
- Background: PubMed 16496488Dart RC, Erdman AR, Olson KR, Christianson G, Manoguerra AS, Chyka PA, Caravati EM, Wax PM, Keyes DC, Woolf AD, Scharman EJ, Booze LL, Troutman WG; American Association of Poison Control Centers. Acetaminophen poisoning: an evidence-based consensus guideline for out-of-hospital management. Clin Toxicol (Phila). 2006;44(1):1-18. doi: 10.1080/15563650500394571.
- 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.
- Background: PubMed 17705945Whyte IM, Francis B, Dawson AH. Safety and efficacy of intravenous N-acetylcysteine for acetaminophen overdose: analysis of the Hunter Area Toxicology Service (HATS) database. Curr Med Res Opin. 2007 Oct;23(10):2359-68. doi: 10.1185/030079907X219715.
- Background: PubMed 19556028Yarema MC, Johnson DW, Berlin RJ, Sivilotti ML, Nettel-Aguirre A, Brant RF, Spyker DA, Bailey B, Chalut D, Lee JS, Plint AC, Purssell RA, Rutledge T, Seviour CA, Stiell IG, Thompson M, Tyberg J, Dart RC, Rumack BH. Comparison of the 20-hour intravenous and 72-hour oral acetylcysteine protocols for the treatment of acute acetaminophen poisoning. Ann Emerg Med. 2009 Oct;54(4):606-14. doi: 10.1016/j.annemergmed.2009.05.010. Epub 2009 Jun 25.
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.
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 5 inclusion and 5 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 25 Jul 2023. 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?
Length of NAC treatment in hours (time frame: Retrospective data collection for patient's hospital admission, max estimated 5days). 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 NCT01465542, 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 25 Jul 2023.