Clinical trial NCT01465542: Treatment of APAP Toxicity With IV and Oral NAC 2008-2011
Official title: Treatment of Acetaminophen Toxicity With Intravenous vs. Oral N-acetylcysteine: A Retrospective Review
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acetaminophen Toxicity
Keywords: Acetaminophen Toxicity
Acetaminophen Overdose
N-acetylcysteine
Liver Toxicity
Lead sponsor: Akron Children's Hospital
Sponsor class: OTHER
First posted: 2011-11-04
Enrollment: 47
Sex: ALL
Minimum age (years): 1
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric and adolescent patients with acetaminophen toxicity.

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Length of NAC treatment in hours
timeFrame: Retrospective data collection for patient's hospital admission, max estimated 5days
Secondary outcomes:
measure: Pharmacology & Toxicology consults
timeFrame: Retrospective data collection for length of patient's hospital admission, max estimated 5 days
Other outcomes:
Locations:
city: Akron
country: United States
facility: Children's Hospital Medical Center of Akron
state: Ohio
Study officials:
affiliation: CHMCA
name: Martha Blackford, PharmD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.