Pharmacokinetics of Dexmedetomidine in Children During Cardiopulmonary Bypass (CPB)

Pharmacokinetics Clinical Trial

Official title:

Pharmacokinetics of Dexmedetomidine in Children During Cardiopulmonary Bypass (CPB)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02059343
• Other study ID #: Pro00049942
• Secondary ID: K24HD05873505
• Status: Completed
• Phase: N/A
• First received: February 5, 2014
• Last updated: November 21, 2014
• Start date: March 2014
• Est. completion date: November 2014

Study information

• Verified date: October 2014
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 2014
• Est. primary completion date: October 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 2 Years

Eligibility

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

Study Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiopulmonary Bypass
• Children
• Pharmacokinetics

Locations

Country	Name	City	State
United States	Duke University Hospital	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Vital sign variation as a measure of safety	Adverse events of special interest will be evaluated. These will include the presence of bradycardia, hypertension, and hypotension that occur after administration of dexmedetomidine	up to 48 hours after study drug initiation	Yes
Primary	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	No
Secondary	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.	No
Secondary	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	No