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Completed

NCT Number: NCT00725179

Treatment of Acetaminophen Toxicity With N-acetylcysteine

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

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Key information

Conditions

Acetaminophen Toxicity

Sex eligibility

All sexes

Study type

Observational

Primary location

Children's Hospital Medical Center of Akron

Akron, Ohio, 44703, 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, 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

Treatment and study plan

Primary outcomes

  1. Duration of oral vs IV NAC treatment in hours

    Time frame: From admission to discharge

Secondary outcomes

  1. Overall healthcare costs associated with IV vs Oral NAC treatment

    Time frame: From admission to discharge

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
2008
Primary completion
2008
Study completion
2008
First posted
Jul 30, 2008
Registry last updated
Sep 9, 2011

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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