Pharmacokinetics of Dexmedetomidine in Children During Cardiopulmonary Bypass (CPB)

Study Overview
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Brief Summary
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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.

Official Title
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Pharmacokinetics of Dexmedetomidine in Children During Cardiopulmonary Bypass (CPB)

Conditions
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Children, Pharmacokinetics, Cardiopulmonary Bypass

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| age less than or equal to 2 years<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 Clearance (CL) Volume of distribution (V) Area under the curve (AUC) Oxygenator extraction efficiency | 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 Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pharmacokinetics, pharmacodynamics, safety, dexmedetomidine, cardiopulmonary bypass, children