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

This study has been completed.
Information provided by (Responsible Party):
Martha Blackford, Akron Children's Hospital Identifier:
First received: October 31, 2011
Last updated: November 2, 2011
Last verified: November 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.

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:
  • 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 Outcome Measures:
  • 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

Enrollment: 47
Study Start Date: June 2011
Study Completion Date: November 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Oral NAC
Patients receiving oral NAC treatment after an acute acetaminophen ingestion.
Patients receiving IV NAC after an acute Acetaminophen ingestion.


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.

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, assualt, 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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01465542

United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Sponsors and Collaborators
Akron Children's Hospital
Principal Investigator: Martha Blackford, PharmD CHMCA
  More Information

Responsible Party: Martha Blackford, PharmD, Akron Children's Hospital Identifier: NCT01465542     History of Changes
Other Study ID Numbers: APAP & NAC 2008-2011
Study First Received: October 31, 2011
Last Updated: November 2, 2011

Keywords provided by Martha Blackford, Akron Children's Hospital:
Acetaminophen Toxicity
Acetaminophen Overdose
Liver Toxicity

Additional relevant MeSH terms:
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antiviral Agents
Anti-Infective Agents
Respiratory System Agents
Free Radical Scavengers
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antidotes processed this record on June 26, 2017