Clinical trial NCT02059343: Pharmacokinetics of Dexmedetomidine in Children During Cardiopulmonary Bypass (CPB)
Official title: Pharmacokinetics of Dexmedetomidine in Children During Cardiopulmonary Bypass (CPB)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pharmacokinetics
Cardiopulmonary Bypass
Children
Keywords: pharmacokinetics
pharmacodynamics
safety
dexmedetomidine
cardiopulmonary bypass
children
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2014-02-11
Enrollment: 18
Sex: ALL
Maximum age (years): 2
Standard ages: CHILD
Accepts healthy volunteers: no
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include children less than or equal to 2 years of age who undergo cardiopulmonary bypass and receive dexmedetomidine per standard of care during the bypass session.

Brief summary: Dexmedetomidine is increasingly used for sedation in children placed on cardiopulmonary bypass for heart surgery. It is also often used after surgery and may be particularly helpful for children with heart disease. In order for this medication to be helpful and to minimize risks associated with taking the medication, it is important to provide correct dosing for this medication. Based on evidence from studies of other medications used during heart surgery, it is likely that dosing of dexmedetomidine while on cardiopulmonary bypass is different from dosing in other settings. The purpose of this study is to evaluate how the heart-lung bypass machine affects dexmedetomidine levels in the body.


Eligibility criteria: Inclusion Criteria:

* \< 2 years of age
* Sufficient venous access to permit administration of study medication.
* Supported with cardiopulmonary bypass (CPB)
* Receiving dexmedetomidine per standard of care.
* Availability and willingness of the parent/legal guardian to provide written informed consent.

Exclusion Criteria:

* \<38 weeks post menstrual age
* Any concomitant condition, which in the opinion of the investigator would preclude a subject's participation in the study.
* Previous participation in this study
* CPB circuit primed with clear fluid

Primary outcomes:
measure: Plasma pharmacokinetics (clearance, volume of distribution, area under the curve, oxygenator extraction efficiency) of dexmedetomidine in children supported with cardiopulmonary bypass
timeFrame: Data will be collected at the following approximate time points: 0h, 0.5h, 0.75h, and 2h after infusion initiation; 0.25h, 0.75h, and 2h after bypass initiation; 0.5h prior to bypass termination, 0.25h, 1h, 3h, 7h, and 10h after bypass termination
Secondary outcomes:
measure: COMFORT behavioral score as a measure of dexmedetomidine pharmacodynamics
timeFrame: assessed at time 0, upon presentation to the intensive care unit after surgery, and 12-24 hours from study drug initiation.
measure: Accessory sedative and analgesic use as a measure of dexmedetomidine pharmacodynamics
timeFrame: up to 48 hours after study drug initiation
Other outcomes:
measure: Vital sign variation as a measure of safety
timeFrame: up to 48 hours after study drug initiation
Locations:
city: Durham
country: United States
facility: Duke University Hospital
state: North Carolina
Study officials:
affiliation: Duke University
name: Kevin Watt, MD
role: PRINCIPAL_INVESTIGATOR
References: