Treatment of Acetaminophen Toxicity With N-acetylcysteine
1 other identifier
observational
130
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Aug 2008
Shorter than P25 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
July 25, 2008
CompletedFirst Posted
Study publicly available on registry
July 30, 2008
CompletedStudy Start
First participant enrolled
August 1, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2008
CompletedStudy Completion
Last participant's last visit for all outcomes
October 1, 2008
CompletedSeptember 9, 2011
September 1, 2011
1 month
July 25, 2008
September 8, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Duration of oral vs IV NAC treatment in hours
From admission to discharge
Secondary Outcomes (1)
Overall healthcare costs associated with IV vs Oral NAC treatment
From admission to discharge
Study Arms (2)
1
Patients receiving oral NAC treatment
2
Patients receiving IV NAC treatment
Eligibility Criteria
Pediatric and adolescent patients with acetaminophen toxicity
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Children's Hospital Medical Center of Akron
Akron, Ohio, 44703, United States
Related Publications (4)
Heard KJ. Acetylcysteine for acetaminophen poisoning. N Engl J Med. 2008 Jul 17;359(3):285-92. doi: 10.1056/NEJMct0708278.
PMID: 18635433BACKGROUNDCulley 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.
PMID: 16180933BACKGROUNDKanter 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.
PMID: 16990628BACKGROUNDBlackford 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.
PMID: 21890206DERIVED
Study Officials
- PRINCIPAL INVESTIGATOR
Martha Blackford, PharmD
CHMCA
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- RETROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- PharmD
Study Record Dates
First Submitted
July 25, 2008
First Posted
July 30, 2008
Study Start
August 1, 2008
Primary Completion
September 1, 2008
Study Completion
October 1, 2008
Last Updated
September 9, 2011
Record last verified: 2011-09