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CompletedNCT01465542Updated Jul 25, 2023

Treatment of APAP Toxicity With IV and Oral NAC 2008-2011

An observational study in Acetaminophen Toxicity, sponsored by Akron Children's Hospital. Completed at 1 site in United States. Open to participants aged 1 Month to 21 Years. Per ClinicalTrials.gov, last updated 2023-07-25.

Sponsored by Akron Children's Hospital · Observational

Study type
Observational
Model
Case-only
Time perspective
Retrospective
Enrollment
47
Ages
1 Month to 21 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Acetaminophen Toxicity

Keywords

  • Acetaminophen Toxicity
  • Acetaminophen Overdose
  • N-acetylcysteine
  • Liver Toxicity
03

In context

Lead sponsor

Akron Children's Hospital is the lead sponsor of 31 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
1 Month to 21 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Pediatric and adolescent patients with acetaminophen toxicity.

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

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
05

Study design

Observational model
Case-only
Time perspective
Retrospective
Enrollment
47 participants (actual)

Groups and cohorts

  • Oral NAC

    Patients receiving oral NAC treatment after an acute acetaminophen ingestion.

  • IV NAC

    Patients receiving IV NAC after an acute Acetaminophen ingestion.

06

What researchers measure

Primary outcomes

  1. Length of NAC treatment in hours

    Length of NAC treatment (in hours) for both IV and PO formulations used in patients with APAP toxicity

    Time frame: 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

    Time frame: Retrospective data collection for length of patient's hospital admission, max estimated 5 days

07

Study locations

1 site
  • Children's Hospital Medical Center of Akron
    Akron, Ohio 44308, United States
08

References and documents

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 16496488 ↗
  • 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. PubMed 16990628 ↗
  • 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. PubMed 17705945 ↗
  • 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. PubMed 19556028 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 25, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT01465542
Lead sponsor
Akron Children's Hospital
Responsible party
Martha Blackford, PharmD (PharmD, Akron Children's Hospital) — Principal investigator
First posted
Nov 4, 2011
Start date
Jun 2011
Primary completion
Aug 2011
Completion
Nov 2011
Last update
Jul 25, 2023

Study contacts

Martha Blackford, PharmD
principal investigator · CHMCA

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2023. You cannot join it, but the record below documents what was studied.

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