Low-dose Epinephrine Infusion Tests in Adolescent and Pediatric Patients (LEAP)

This study has been terminated.
(Lack of enrollment)
Sponsor:
Collaborator:
Children's Healthcare of Atlanta
Information provided by (Responsible Party):
Peter Fischbach, Emory University
ClinicalTrials.gov Identifier:
NCT00548886
First received: October 22, 2007
Last updated: February 20, 2015
Last verified: February 2015
Results First Received: February 20, 2015  
Study Type: Interventional
Study Design: Endpoint Classification: Safety Study;   Intervention Model: Single Group Assignment;   Masking: Open Label;   Primary Purpose: Health Services Research
Condition: Congenital Disorders
Intervention: Drug: Epinephrine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects recruited from Children’s Healthcare of Atlanta (CHOA) February 2008 through January 2012

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Epinephrine Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.

Participant Flow:   Overall Study
    Epinephrine  
STARTED     7  
COMPLETED     7  
NOT COMPLETED     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Epinephrine Healthy pediatric subjects will receive epinephrine. Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes.The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes. The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes. The epinephrine infusion is then discontinued.

Baseline Measures
    Epinephrine  
Number of Participants  
[units: participants]
  7  
Age  
[units: participants]
 
<=18 years     7  
Between 18 and 65 years     0  
>=65 years     0  
Gender  
[units: participants]
 
Female     2  
Male     5  



  Outcome Measures

1.  Primary:   Percentage of Subjects With a Positive Result in Absolute QT Interval   [ Time Frame: 35 minutes ]

2.  Secondary:   Determine Interobserver Variability When Measuring QT Intervals   [ Time Frame: During enrollment period ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.   Safety Issue:   No


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Slow enrollment lead to an early termination of the study


  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Dr. Peter Seth Fischbach
Organization: Emory University
phone: 404-256-2593
e-mail: pfischb@emory.edu



Responsible Party: Peter Fischbach, Emory University
ClinicalTrials.gov Identifier: NCT00548886     History of Changes
Other Study ID Numbers: IRB00008105
Study First Received: October 22, 2007
Results First Received: February 20, 2015
Last Updated: February 20, 2015
Health Authority: United States: Institutional Review Board