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Completed

NCT Number: NCT02059343

Pharmacokinetics of Dexmedetomidine in Children During Cardiopulmonary Bypass (CPB)

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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Key information

Conditions

Pharmacokinetics Cardiopulmonary Bypass Children

Age range

Up to 2 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Duke University Hospital

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Duke University

Other

Registry information

Important dates

Study start
2014
Primary completion
2014
Study completion
2014
First posted
Feb 11, 2014
Registry last updated
Nov 24, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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