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

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.

Study Overview

• Status: Completed
• Conditions: Acetaminophen Toxicity

• Study Type: Observational
• Enrollment (Actual): 47

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric and adolescent patients with acetaminophen toxicity.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of NAC treatment in hours	Length of NAC treatment (in hours) for both IV and PO formulations used in patients with APAP toxicity	Retrospective data collection for patient's hospital admission, max estimated 5days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pharmacology & Toxicology consults	Documenting whether or not a pharmacology & toxicology consult was obtained during the patient's hospital admission for APAP toxicity	Retrospective data collection for length of patient's hospital admission, max estimated 5 days

Collaborators and Investigators

• Sponsor: Akron Children's Hospital
• Investigators: Principal Investigator: Martha Blackford, PharmD, CHMCA

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): August 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: October 31, 2011
• First Submitted That Met QC Criteria: November 2, 2011
• First Posted (Estimated): November 4, 2011

Study Record Updates

• Last Update Posted (Actual): July 25, 2023
• Last Update Submitted That Met QC Criteria: July 24, 2023
• Last Verified: July 1, 2023

More Information

Terms related to this study

• Keywords: N-acetylcysteine; Acetaminophen Toxicity; Acetaminophen Overdose; Liver Toxicity
• Other Study ID Numbers: APAP & NAC 2008-2011