Treatment of APAP Toxicity With IV and Oral NAC 2008-2011
NCT ID: NCT01465542
Last Updated: 2023-07-25
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
47 participants
OBSERVATIONAL
2011-06-30
2011-11-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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CASE_ONLY
RETROSPECTIVE
Study Groups
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Oral NAC
Patients receiving oral NAC treatment after an acute acetaminophen ingestion.
No interventions assigned to this group
IV NAC
Patients receiving IV NAC after an acute Acetaminophen ingestion.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
1 Month
21 Years
ALL
No
Sponsors
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Akron Children's Hospital
OTHER
Responsible Party
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Martha Blackford, PharmD
PharmD
Principal Investigators
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Martha Blackford, PharmD
Role: PRINCIPAL_INVESTIGATOR
CHMCA
Locations
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Children's Hospital Medical Center of Akron
Akron, Ohio, United States
Countries
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References
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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.
Kanter 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.
Whyte 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.
Yarema 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.
Other Identifiers
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APAP & NAC 2008-2011
Identifier Type: -
Identifier Source: org_study_id
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