PharmacokineticsNCT02059343
Pharmacokinetics of Dexmedetomidine in Children During Cardiopulmonary Bypass (CPB)
An observational study of Pharmacokinetics and Cardiopulmonary Bypass, run by Duke University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages Up to 2 years
- Conditions the study is for
- Pharmacokinetics, Cardiopulmonary Bypass, Children
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2014to Nov 2014
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 2 years
- All sexes
- No healthy volunteers
- Child
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.
Who may be able to join
- < 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.
Who cannot join
- <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
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27705
About this study
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.
- Conditions
- Pharmacokinetics, Cardiopulmonary Bypass, Children
- Keywords
- pharmacokinetics, pharmacodynamics, safety, dexmedetomidine, cardiopulmonary bypass, children
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| age less than or equal to 2 years | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Secondary outcomes (2)
COMFORT behavioral score as a measure of dexmedetomidine pharmacodynamics
Measured: assessed at time 0, upon presentation to the intensive care unit after surgery, and 12-24 hours from study drug initiation.
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.
Measured: up to 48 hours after study drug initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2014 (estimated)
- Study startMar 2014
- Primary completionOct 2014
- Study completionNov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PharmacokineticsStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kevin Watt, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02059343
- Sponsor's protocol ID
- Pro00049942
- Other IDs
- K24HD05873505
- Status last verified
- Oct 2014
- First submitted
- 5 Feb 2014
- Last updated
- 24 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacokinetics of Dexmedetomidine in Children During Cardiopulmonary Bypass (CPB)
- ClinicalTrials.gov ID
- NCT02059343
- Acronym / sponsor ID
- Pro00049942
- Conditions
- Pharmacokinetics, Cardiopulmonary Bypass, Children
- Keywords
- pharmacokinetics, pharmacodynamics, safety, dexmedetomidine, cardiopulmonary bypass, children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Mar 2014
- Primary completion
- Oct 2014 (actual)
- Study completion
- Nov 2014 (actual)
- First posted
- 11 Feb 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| age less than or equal to 2 years | – | – |
Who may qualify
- Ages
- Up to 2 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- 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.
Key inclusion criteria (5 listed)
- < 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.
Key exclusion criteria (4 listed)
- <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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
2 secondary outcomes
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.
Accessory sedative and analgesic use as a measure of dexmedetomidine pharmacodynamics
Time frame: up to 48 hours after study drug initiation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kevin Watt, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pharmacokinetics and Cardiopulmonary Bypass, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2014.