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Pharmacokinetics of Dexmedetomidine in Children During Cardiopulmonary Bypass (CPB)

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ClinicalTrials.gov Identifier: NCT02059343
Recruitment Status : Completed
First Posted : February 11, 2014
Last Update Posted : November 24, 2014
Sponsor:
Information provided by (Responsible Party):
Duke University

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.

Condition or disease
Pharmacokinetics Cardiopulmonary Bypass Children

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Study Type : Observational
Actual Enrollment : 18 participants
Time Perspective: Prospective
Official Title: Pharmacokinetics of Dexmedetomidine in Children During Cardiopulmonary Bypass (CPB)
Study Start Date : March 2014
Actual Primary Completion Date : October 2014
Actual Study Completion Date : November 2014

Group/Cohort
age less than or equal to 2 years



Primary Outcome Measures :
  1. Plasma pharmacokinetics (clearance, volume of distribution, area under the curve, oxygenator extraction efficiency) of dexmedetomidine in children supported with cardiopulmonary bypass [ Time Frame: 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 Outcome Measures :
  1. COMFORT behavioral score as a measure of dexmedetomidine pharmacodynamics [ Time Frame: assessed at time 0, upon presentation to the intensive care unit after surgery, and 12-24 hours from study drug initiation. ]
  2. Accessory sedative and analgesic use as a measure of dexmedetomidine pharmacodynamics [ Time Frame: 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 Outcome Measures:
  1. Vital sign variation as a measure of safety [ Time Frame: 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


Biospecimen Retention:   Samples Without DNA
Blood will be collected for plasma pharmacokinetic analysis.


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Ages Eligible for Study:   up to 2 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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.
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02059343


Locations
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United States, North Carolina
Duke University Hospital
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Duke University
Investigators
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Principal Investigator: Kevin Watt, MD Duke University
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02059343    
Other Study ID Numbers: Pro00049942
K24HD05873505 ( Other Grant/Funding Number: NICHD )
First Posted: February 11, 2014    Key Record Dates
Last Update Posted: November 24, 2014
Last Verified: October 2014
Keywords provided by Duke University:
pharmacokinetics
pharmacodynamics
safety
dexmedetomidine
cardiopulmonary bypass
children