- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00548886
Low-dose Epinephrine Infusion Tests in Adolescent and Pediatric Patients (LEAP)
Long QT syndrome (LQTS)is a cardiac disorder that may lead to ventricular arrythmias and culminate in syncope and/or possible death.
Recently, researchers have developed a way of discovering patients with LQTS by using low doses of epinephrine by a continuous, intravenous infusion in adults. Epinephrine, or adrenaline, is produced by our bodies in times of stress. By producing adrenaline, your body allows itself to adapt to its stressful environment and take appropriate actions (i.e. fight or flight response). By simulating this response with very small amounts of epinephrine, researchers have shown prolongation of the QT interval does not occur in normal healthy adults. However, adults with confirmed LQTS Type 1 (LQTS-1) will prolong their QT interval when given low dose epinephrine. Therefore, this test can act as a safe means of identifying adults with LQTS-1 who do not have prolonged QT intervals on their resting EKGs.
However, LQTS is not just a disease of adults, it affects children as well. Currently the standard of care is to obtain resting EKGs on our pediatric patients which can miss those patients with concealed LQTS. Those patients, who are old enough, can undergo exercise testing. Yet this leaves young children unable to run on a treadmill without a diagnostic test.
Hypothesis: The low-dose epinephrine infusion stress test does not cause prolongation of the QT interval in an electrophysiologically normal healthy pediatric population.
Study Overview
Detailed Description
This study will involve asking fifty children coming to the hospital for their standard of care procedure to treat a separate cardiac condition to participate. Patients approached will already have an intravenous line in place for their procedure. After consent and assent as necessary are obtained, the patient be brought to a separate room for the low-dose epinephrine infusion trial. The patient will lie down on a table, be hooked up to an EKG machine and the infusion will start. The amount of epinephrine actually infused is based on the weight of the patient but is substantially less than the dose received from an epinephrine auto-injection for anaphylaxis. After about 40 minutes, the trial will be completed and the patient may return to the waiting room for their original procedure. We have performed this test on a number of pediatric patients suspected of having LQTS with promising results and with little to no side effects. The patient will be awake for the procedure and will be able to verbalize concerns or complaints. A pediatric electrophysiologist and nurse will be present throughout the entire procedure.
The purpose of this study is to determine if children who are infused with low amounts of epinephrine will also maintain their normal QT interval as it does with healthy adults. This study would hope to prove that low-dose epinephrine infusion trials can serve as a way of identifying children with LQTS so that they may be effectively treated and potentially have their lives saved.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Georgia
-
Atlanta, Georgia, United States, 30322
- Children's Healthcare of Atlanta
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients ages 3-18 years
- Patients undergoing device closure of an atrial septal defect in the cardiac catheterization lab
- normal electrocardiogram without prolonged absolute or corrected QT interval(less than 440 msec)
Exclusion Criteria:
- Patients with a history of any other structural or acquired heart disease besides the atrial septal defect.
- Patient with a family history of sudden cardiac death, or personal history of syncope.
- Patient on alpha or beta-blocking medications.
- Pregnancy.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 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.
|
We will follow the protocol outlined by Ackerman et al. known as the Mayo protocol4 which is currently used routinely in our electrophysiology laboratory.
Epinephrine infusion will begin at 0.025 ug/kg/minute, for ten minutes and a twelve-lead electrocardiogram is obtained at time=0 minutes, 5 minutes, and 10 minutes.
The epinephrine infusion will then be increased to 0.05 ug/kg/minute for five minutes and the electrocardiogram repeated.
The epinephrine infusion will then be increased to a maximal dose of 0.1 ug/kg/minute for five minutes and electrocardiogram obtained.
The epinephrine infusion is then discontinued and measurements are obtained at five minutes and ten minutes after stopping the epinephrine infusion.
The total time of procedure will be 35 minutes.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Percentage of Subjects With a Positive Result in Absolute QT Interval
Time Frame: 35 minutes
|
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.
|
35 minutes
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Determine Interobserver Variability When Measuring QT Intervals
Time Frame: During enrollment period
|
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.
|
During enrollment period
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Peter Fischbach, MD, MA, Emory University
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Adrenergic Agents
- Neurotransmitter Agents
- Molecular Mechanisms of Pharmacological Action
- Autonomic Agents
- Peripheral Nervous System Agents
- Adrenergic alpha-Agonists
- Adrenergic Agonists
- Bronchodilator Agents
- Anti-Asthmatic Agents
- Respiratory System Agents
- Adrenergic beta-Agonists
- Sympathomimetics
- Vasoconstrictor Agents
- Mydriatics
- Epinephrine
Other Study ID Numbers
- IRB00008105
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Congenital Disorders
-
University College London HospitalsRecruiting
-
Children's Healthcare of AtlantaCompletedCongenital DisordersUnited States
-
Children's Healthcare of AtlantaCompleted
-
Children's Healthcare of AtlantaTerminated
-
Children's Healthcare of AtlantaTerminatedCongenital DisordersUnited States
-
Children's Healthcare of AtlantaTerminated
-
Children's Healthcare of AtlantaTerminated
-
Children's Healthcare of AtlantaTerminated
-
Children's Healthcare of AtlantaWithdrawn
-
Children's Healthcare of AtlantaCompleted
Clinical Trials on Epinephrine
-
Tel Aviv UniversitySheba Medical Center; Private practice, Dr. Malka AshkenaziUnknown
-
Seoul Medical CenterCompletedSpinal Anesthesia | Total Knee Replacement ArthroplastyKorea, Republic of
-
Seoul Medical CenterCompleted
-
Amphastar Pharmaceuticals, Inc.CompletedAsthma | Shortness of Breath | Wheezing | BronchospasmUnited States
-
Dr. Aayush Khanal, MDCompleted
-
Amphastar Pharmaceuticals, Inc.Terminated
-
De Motu CordisNovotech (Australia) Pty LimitedCompletedAnaphylactic ReactionAustralia
-
Amphastar Pharmaceuticals, Inc.Completed
-
Boston Children's HospitalEnrolling by invitationHypotensionUnited States