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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.
 
ClinicalTrials.gov Identifier: NCT01465542
Recruitment Status : Completed
First Posted : November 4, 2011
Last Update Posted : September 11, 2017
Sponsor:
Information provided by (Responsible Party):
Martha Blackford, PharmD, Akron Children's Hospital

Tracking Information
First Submitted Date October 31, 2011
First Posted Date November 4, 2011
Last Update Posted Date September 11, 2017
Study Start Date June 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 2, 2011)
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
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: November 2, 2011)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Treatment of APAP Toxicity With IV and Oral NAC 2008-2011
Official Title Treatment of Acetaminophen Toxicity With Intravenous vs. Oral N-acetylcysteine: A Retrospective Review
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Case-Only
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Pediatric and adolescent patients with acetaminophen toxicity.
Condition Acetaminophen Toxicity
Intervention Not Provided
Study 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.
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 2, 2011)
47
Original Actual Enrollment Same as current
Actual Study Completion Date November 2011
Actual Primary Completion Date August 2011   (Final data collection date for primary outcome measure)
Eligibility 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
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT01465542
Other Study ID Numbers APAP & NAC 2008-2011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Martha Blackford, PharmD, Akron Children's Hospital
Study Sponsor Akron Children's Hospital
Collaborators Not Provided
Investigators
Principal Investigator: Martha Blackford, PharmD CHMCA
PRS Account Akron Children's Hospital
Verification Date September 2017