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

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:

Drug Information available for: Acetaminophen Acetylcysteine

U.S. FDA Resources

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

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:

Dart RC, Erdman AR, Olson KR, Christianson G, Manoguerra AS, Chyka PA, Caravati EM, Wax PM, Keyes DC, Woolf AD, Scharman EJ, Booze LL, Troutman WG; American Association of Poison Control Centers. Acetaminophen poisoning: an evidence-based consensus guideline for out-of-hospital management. Clin Toxicol (Phila). 2006;44(1):1-18.

Kanter MZ. Comparison of oral and i.v. acetylcysteine in the treatment of acetaminophen poisoning. Am J Health Syst Pharm. 2006 Oct 1;63(19):1821-7. Review.

Whyte IM, Francis B, Dawson AH. Safety and efficacy of intravenous N-acetylcysteine for acetaminophen overdose: analysis of the Hunter Area Toxicology Service (HATS) database. Curr Med Res Opin. 2007 Oct;23(10):2359-68.

Yarema MC, Johnson DW, Berlin RJ, Sivilotti ML, Nettel-Aguirre A, Brant RF, Spyker DA, Bailey B, Chalut D, Lee JS, Plint AC, Purssell RA, Rutledge T, Seviour CA, Stiell IG, Thompson M, Tyberg J, Dart RC, Rumack BH. Comparison of the 20-hour intravenous and 72-hour oral acetylcysteine protocols for the treatment of acute acetaminophen poisoning. Ann Emerg Med. 2009 Oct;54(4):606-14. Epub 2009 Jun 25.

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
Antipyretics
Physiological Effects of Drugs
Pharmacologic Actions
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents

Therapeutic Uses
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 May 22, 2013