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

Acetaminophen Toxicity Clinical Trial

Official title:

Treatment of Acetaminophen Toxicity With Intravenous vs. Oral N-acetylcysteine: A Retrospective Review

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01465542
• Other study ID #: APAP & NAC 2008-2011
• Status: Completed
• Start date: June 2011
• Est. completion date: November 2011

Study information

• Verified date: July 2023
• Source: Akron Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 47
• Est. completion date: November 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Month to 21 Years

Eligibility

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

Related Conditions & MeSH terms

• Acetaminophen Toxicity

Locations

Country	Name	City	State
United States	Children's Hospital Medical Center of Akron	Akron	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Akron Children's Hospital

Country where clinical trial is conducted

United States, 

References & Publications (4)

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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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