A Pharmacokinetic Study of Dexmedetomine in Infants

Study Overview
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Brief Summary
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Blind randomized trial of a single bolus dose of dexmedetomine followed by a continuous infusion (CIVI) for up to 24 hours in infants who immediately post-operative from cardiac surgery and require tracheal intubation with mechanical ventilation in the post-operative period. Three bolus and infusion dose will be administered to a total of 36 patients.

Detailed Description
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This clinical trial of three dose rates of dexmedetomine will determine the pharmacokinetics of the drug in infants who remain tracheally intubated postoperatively. An exploratory pharmacodynamic study of a non-invasive device measuring sedation will be performed. Although the pharmacokinetics of dexmedetomine have been described for pediatric patients, the drug disposition in infants has not been well described. A range of doses has been studied, yet there are no reports describing the optimal dose for post-operative pediatric patients. This study will provide data that may allow for improved dosing recommendations in this critically ill population of children.

Official Title
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A Pharmacokinetic Study of Dexmedetomine in Infants

Conditions
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Cardiac Surgical Procedures

Intervention / Treatment
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* Drug: Dexmedetomine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Greater than or equal to 1 month, less than or equal to 24 months Post-operative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-operative period Planned tracheal extubation within 24 hours post-operative period Renal function-serum creatine = 1.5 times the ULN for age Total bilirubin less than or equal to 1.5 X upper limit of normal (ULN) for age SGPT (ALT) ,less than+ 3x upper limit of normal (ULN) for age Signed written informed consent Exclusion Criteria: Patients who have received another investigational drug within the past 30 days Receiving intermittent or continuous muscle relaxation during study period Patients who have a positive blood culture without a subsequent negative culture or other evidence of ongoing serious infection. Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study. Post-Operative hypotension Heart block Weight < 5 kg Patients who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study.

Ages Eligible for Study
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Minimum Age: 1 Month
Maximum Age: 24 Months

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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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Dexmedetomine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics: vital signs, cardiac rhythm, oxygen saturation, laboratory evaluations and adverse events will be monitored to determine the safety of dexmedetomine. |  |  | 
| Pharmacokinetics: will measure plasma concentrations for dose escalations of dexmedetomine to determine the maximum tolerated dose (MTD). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamics: The Bispectral Index Scale(BIS) and the University of Michigan sedation scale will be used to measure the level of sedation and dexmedetomine plasma drug concentrations. |  |  | 
| Pharmacogenetics: will examine the relationship between genotype, drug exposure and drug response in infants postoperative form cardiac surgery. |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dexmedetomine, Post-operative cardiac surgery