A Pharmacokinetic Study of Dexmedetomine in Infants
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1 |
Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- 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
- 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. []
Eligibility Criteria
Criteria
Inclusion Criteria:
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Greater than or equal to 1 month, less than or equal to 24 months
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Post-operative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-operative period
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Planned tracheal extubation within 24 hours post-operative period
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Renal function-serum creatine = 1.5 times the ULN for age
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Total bilirubin less than or equal to 1.5 X upper limit of normal (ULN) for age
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SGPT (ALT) ,less than+ 3x upper limit of normal (ULN) for age
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Signed written informed consent
Exclusion Criteria:
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Patients who have received another investigational drug within the past 30 days
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Receiving intermittent or continuous muscle relaxation during study period
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Patients who have a positive blood culture without a subsequent negative culture or other evidence of ongoing serious infection.
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Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
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Post-Operative hypotension
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Heart block
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Weight < 5 kg
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Patients who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- PPRU 10760