Cardiopulmonary Bypass, Children, Pharmacokinetics
Conditions
Keywords
pharmacokinetics, pharmacodynamics, safety, dexmedetomidine, cardiopulmonary bypass, children
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.
Interventions
None listed
Sponsors
Duke University
Study design
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 2 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma pharmacokinetics (clearance, volume of distribution, area under the curve, oxygenator extraction efficiency) of dexmedetomidine in children supported with cardiopulmonary bypass | 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 | The plasma pharmacokinetics of dexmedetomidine will include * Clearance (CL) * Volume of distribution (V) * Area under the curve (AUC) * Oxygenator extraction efficiency |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| COMFORT behavioral score as a measure of dexmedetomidine pharmacodynamics | assessed at time 0, upon presentation to the intensive care unit after surgery, and 12-24 hours from study drug initiation. | — |
| Accessory sedative and analgesic use as a measure of dexmedetomidine pharmacodynamics | up to 48 hours after study drug initiation | We will monitor sedatives and analgesics used in addition to dexmedetomidine. Quantification of use of other drugs will allow an indication of the sedative effects of dexmedetomidine. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Vital sign variation as a measure of safety | up to 48 hours after study drug initiation | Adverse events of special interest will be evaluated. These will include the presence of bradycardia, hypertension, and hypotension that occur after administration of dexmedetomidine |
Countries
United States
Outcome results
None listed