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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Martha Blackford, Akron Children's Hospital
ClinicalTrials.gov Identifier:
NCT01465542
First received: October 31, 2011
Last updated: November 2, 2011
Last verified: November 2011
  Purpose

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
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 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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)
Groups/Cohorts
Oral NAC
Patients receiving oral NAC treatment after an acute acetaminophen ingestion.
IV NAC
Patients receiving IV NAC after an acute Acetaminophen ingestion.

  Eligibility

Genders Eligible for Study:   Both
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, 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 ClinicalTrials.gov identifier: NCT01465542

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

Publications:
Responsible Party: Martha Blackford, PharmD, Akron Children's Hospital
ClinicalTrials.gov Identifier: NCT01465542     History of Changes
Other Study ID Numbers: APAP & NAC 2008-2011
Study First Received: October 31, 2011
Last Updated: November 2, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Akron Children's Hospital:
Acetaminophen Toxicity
Acetaminophen Overdose
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
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Antipyretics
Antiviral Agents
Anti-Infective Agents
Expectorants
Respiratory System Agents
Free Radical Scavengers
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Antidotes

ClinicalTrials.gov processed this record on September 18, 2014