Treatment of Acetaminophen Toxicity With N-acetylcysteine

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: NCT00725179
• Other study ID #: APAP & NAC
• Status: Completed
• Phase: N/A
• First received: July 25, 2008
• Last updated: September 8, 2011
• Start date: August 2008
• Est. completion date: October 2008

Study information

• Verified date: September 2011
• Source: Akron Children's Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

Retrospective chart review of patients who received N-acetylcysteine for APAP toxicity to assess length of oral vs IV treatment and overall healthcare costs.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 130
• Est. completion date: October 2008
• Est. primary completion date: September 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Admitted to CHMCA between June 1, 2004 to May 31, 2008 with a 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 concentrations = 150 g/mL at 4 hours or a serum concentration above the possible hepatotoxic line on the Rumack-Matthew's nomogram if obtained > 4 hours post ingestion

• Between the ages of 0-21 years

Exclusion Criteria:

• Serum APAP concentrations are not actually documented

• Patient did not receive oral or IV NAC treatment

• Patient has a preexisting liver disease such as cirrhosis or hepatitis C

• Patient > 21 years of age

Study Design

Observational Model: Case-Only, Time Perspective: Retrospective

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 (3)

Culley CM, Krenzelok EP. A clinical and pharmacoeconomic justification for intravenous acetylcysteine: a US perspective. Toxicol Rev. 2005;24(2):131-43. Review. — View Citation

Heard KJ. Acetylcysteine for acetaminophen poisoning. N Engl J Med. 2008 Jul 17;359(3):285-92. doi: 10.1056/NEJMct0708278. Review. — 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Duration of oral vs IV NAC treatment in hours		From admission to discharge	No
Secondary	Overall healthcare costs associated with IV vs Oral NAC treatment		From admission to discharge	No