NCT01465542

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2011

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2011

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

October 31, 2011

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2011

Completed
Last Updated

July 25, 2023

Status Verified

July 1, 2023

Enrollment Period

2 months

First QC Date

October 31, 2011

Last Update Submit

July 24, 2023

Conditions

Acetaminophen Toxicity

Keywords

Acetaminophen ToxicityAcetaminophen OverdoseN-acetylcysteineLiver Toxicity

Outcome Measures

Primary Outcomes (1)

  • Length of NAC treatment in hours

    Length of NAC treatment (in hours) for both IV and PO formulations used in patients with APAP toxicity

    Retrospective data collection for patient's hospital admission, max estimated 5days

Secondary Outcomes (1)

  • Pharmacology & Toxicology consults

    Retrospective data collection for length of patient's hospital admission, max estimated 5 days

Study Arms (2)

Oral NAC

Patients receiving oral NAC treatment after an acute acetaminophen ingestion.

IV NAC

Patients receiving IV NAC after an acute Acetaminophen ingestion.

Eligibility Criteria

Age1 Month - 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Pediatric and adolescent patients with acetaminophen toxicity.

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Hospital Medical Center of Akron

Akron, Ohio, 44308, United States

Location

Related Publications (4)

  • 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.

    PMID: 16496488BACKGROUND

  • 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.

    PMID: 16990628BACKGROUND

  • 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.

    PMID: 17705945BACKGROUND

  • 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.

    PMID: 19556028BACKGROUND

Study Officials

  • Martha Blackford, PharmD

    CHMCA

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PharmD

Study Record Dates

First Submitted

October 31, 2011

First Posted

November 4, 2011

Study Start

June 1, 2011

Primary Completion

August 1, 2011

Study Completion

November 1, 2011

Last Updated

July 25, 2023

Record last verified: 2023-07

Locations

US(1)