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Treatment of Acetaminophen Toxicity With N-acetylcysteine

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00725179
First Posted: July 30, 2008
Last Update Posted: September 9, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Martha Blackford, Akron Children's Hospital
  Purpose
Retrospective chart review of patients who received N-acetylcysteine for APAP toxicity to assess length of oral vs IV treatment and overall healthcare costs.

Condition
Acetaminophen Toxicity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Treatment of Acetaminophen Toxicity With Intravenous vs Oral N-acetylcysteine: A Retrospective Review

Resource links provided by NLM:


Further study details as provided by Martha Blackford, Akron Children's Hospital:

Primary Outcome Measures:
  • Duration of oral vs IV NAC treatment in hours [ Time Frame: From admission to discharge ]

Secondary Outcome Measures:
  • Overall healthcare costs associated with IV vs Oral NAC treatment [ Time Frame: From admission to discharge ]

Estimated Enrollment: 130
Study Start Date: August 2008
Study Completion Date: October 2008
Primary Completion Date: September 2008 (Final data collection date for primary outcome measure)
Groups/Cohorts
1
Patients receiving oral NAC treatment
2
Patients receiving IV NAC treatment

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Pediatric and adolescent patients with acetaminophen toxicity
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00725179


Locations
United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44703
Sponsors and Collaborators
Akron Children's Hospital
Investigators
Principal Investigator: Martha Blackford, PharmD CHMCA
  More Information

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Martha Blackford, PharmD, Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT00725179     History of Changes
Other Study ID Numbers: APAP & NAC
First Submitted: July 25, 2008
First Posted: July 30, 2008
Last Update Posted: September 9, 2011
Last Verified: September 2011

Keywords provided by Martha Blackford, Akron Children's Hospital:
acetaminophen toxicity
n-acetylcysteine
liver toxicity

Additional relevant MeSH terms:
Acetaminophen
Acetylcysteine
N-monoacetylcystine
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antidotes