Trial Outcomes & Findings for Low-dose Epinephrine Infusion Tests in Adolescent and Pediatric Patients (NCT NCT00548886)
NCT ID: NCT00548886
Last Updated: 2017-12-06
Results Overview
QT interval refers to the time interval on the standard electrocardiogram from the beginning of the QRS complex to the end of the T wave. Each participant had four QT intervals measured at each timepoint and the average was calculated for each patient at each timepoint for an absolute QT interval. Lengthening of the absolute QT interval greater than 30 milliseconds on low dose epinephrine infusion would be considered a positive result.
TERMINATED
NA
7 participants
35 minutes
2017-12-06
Participant Flow
Subjects recruited from Children's Healthcare of Atlanta (CHOA) February 2008 through January 2012
Participant milestones
| Measure |
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.
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|---|---|
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Overall Study
STARTED
|
7
|
|
Overall Study
COMPLETED
|
7
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Low-dose Epinephrine Infusion Tests in Adolescent and Pediatric Patients
Baseline characteristics by cohort
| Measure |
Epinephrine
n=7 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
7 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 35 minutesPopulation: Data not analyzed due to study termination
QT interval refers to the time interval on the standard electrocardiogram from the beginning of the QRS complex to the end of the T wave. Each participant had four QT intervals measured at each timepoint and the average was calculated for each patient at each timepoint for an absolute QT interval. Lengthening of the absolute QT interval greater than 30 milliseconds on low dose epinephrine infusion would be considered a positive result.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: During enrollment periodPopulation: Interobserver variability was not performed due to study termination
Two pediatric electrophysiologists were given photocopies of rhythm strips obtained from the electrocardiograms and the electrophysiologists will then take four separate measurements of the QT interval from each rhythm strip. Interobserver variability was measured between the two electrophysiologists and their measurements on the same rhythm strip. False positive results will be based on measurement error.
Outcome measures
Outcome data not reported
Adverse Events
Epinephrine
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place