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

NCT ID: NCT01465542

Last Updated: 2023-07-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

47 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-06-30

Study Completion Date

2011-11-30

Brief Summary

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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.

Detailed Description

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Conditions

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Acetaminophen Toxicity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Oral NAC

Patients receiving oral NAC treatment after an acute acetaminophen ingestion.

No interventions assigned to this group

IV NAC

Patients receiving IV NAC after an acute Acetaminophen ingestion.

No interventions assigned to this group

Eligibility Criteria

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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, assault, 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
Minimum Eligible Age

1 Month

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Akron Children's Hospital

OTHER

Sponsor Role lead

Responsible Party

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Martha Blackford, PharmD

PharmD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Martha Blackford, PharmD

Role: PRINCIPAL_INVESTIGATOR

CHMCA

Locations

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Children's Hospital Medical Center of Akron

Akron, Ohio, United States

Site Status

Countries

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United States

References

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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. doi: 10.1080/15563650500394571.

Reference Type BACKGROUND
PMID: 16496488 (View on PubMed)

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. doi: 10.2146/ajhp060050.

Reference Type BACKGROUND
PMID: 16990628 (View on PubMed)

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. doi: 10.1185/030079907X219715.

Reference Type BACKGROUND
PMID: 17705945 (View on PubMed)

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. doi: 10.1016/j.annemergmed.2009.05.010. Epub 2009 Jun 25.

Reference Type BACKGROUND
PMID: 19556028 (View on PubMed)

Other Identifiers

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APAP & NAC 2008-2011

Identifier Type: -

Identifier Source: org_study_id

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