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| ID | Type | Description | Link |
|---|---|---|---|
| K24HD05873505 | Other Grant/Funding Number | NICHD |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| age less than or equal to 2 years |
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| Measure | Description | Time Frame |
|---|---|---|
| Plasma pharmacokinetics (clearance, volume of distribution, area under the curve, oxygenator extraction efficiency) of dexmedetomidine in children supported with cardiopulmonary bypass | The plasma pharmacokinetics of dexmedetomidine will include
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Vital sign variation as a measure of safety | Adverse events of special interest will be evaluated. These will include the presence of bradycardia, hypertension, and hypotension that occur after administration of dexmedetomidine | up to 48 hours after study drug initiation |
Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Watt, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke University Hospital | Durham | North Carolina | 27705 | United States |
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Blood will be collected for plasma pharmacokinetic analysis.
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.
| up to 48 hours after study drug initiation |