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Completed

NCT Number: NCT01465542

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

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.

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Key information

Conditions

Acetaminophen Toxicity

Age range

1 month–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Length of NAC treatment in hours

    Time frame: 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 outcomes

  1. Pharmacology & Toxicology consults

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Akron Children's Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Nov 4, 2011
Registry last updated
Jul 25, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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