Treatment of Acetaminophen Toxicity With N-acetylcysteine

Completed

• Conditions: Acetaminophen Toxicity

• Registration Number: NCT00725179
• Lead Sponsor: Akron Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-07-25
• Study First Submitted QC: 2008-07-29
• Study First Posted: 2008-07-30
• Study Start: 2008-08
• Primary Completion: 2008-09
• Study Completion: 2008-10
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-08
• Last Update Posted: 2011-09-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 130

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Duration of oral vs IV NAC treatment in hours	From admission to discharge

Secondary Outcome Measures

Name	Time	Method
Overall healthcare costs associated with IV vs Oral NAC treatment	From admission to discharge

Trial Locations

Locations (1)

Children's Hospital Medical Center of Akron; 🇺🇸 Akron, Ohio, United States