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

Completed

• Conditions: Acetaminophen Toxicity

• Registration Number: NCT01465542
• Lead Sponsor: Akron Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06
• Primary Completion: 2011-08
• Study First Submitted: 2011-10-31
• Study Completion: 2011-11
• Study First Submitted QC: 2011-11-02
• Study First Posted: 2011-11-04
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-24
• Last Update Posted: 2023-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 47

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

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