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

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. Identifier: NCT01465542
Recruitment Status : Completed
First Posted : November 4, 2011
Last Update Posted : September 11, 2017
Information provided by (Responsible Party):
Martha Blackford, PharmD, 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.

Condition or disease
Acetaminophen Toxicity

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Study Type : Observational
Actual Enrollment : 47 participants
Observational Model: Case-Only
Time Perspective: Retrospective
Official Title: Treatment of Acetaminophen Toxicity With Intravenous vs. Oral N-acetylcysteine: A Retrospective Review
Study Start Date : June 2011
Actual Primary Completion Date : August 2011
Actual Study Completion Date : November 2011

Oral NAC
Patients receiving oral NAC treatment after an acute acetaminophen ingestion.
Patients receiving IV NAC after an acute Acetaminophen ingestion.

Primary Outcome Measures :
  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 Outcome Measures :
  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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
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

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 identifier (NCT number): NCT01465542

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United States, Ohio
Children's Hospital Medical Center of Akron
Akron, Ohio, United States, 44308
Sponsors and Collaborators
Akron Children's Hospital
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Principal Investigator: Martha Blackford, PharmD CHMCA
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Responsible Party: Martha Blackford, PharmD, PharmD, Akron Children's Hospital Identifier: NCT01465542    
Other Study ID Numbers: APAP & NAC 2008-2011
First Posted: November 4, 2011    Key Record Dates
Last Update Posted: September 11, 2017
Last Verified: September 2017
Keywords provided by Martha Blackford, PharmD, Akron Children's Hospital:
Acetaminophen Toxicity
Acetaminophen Overdose
Liver Toxicity