Pharmacokinetics of Dexmedetomidine in Children During Cardiopulmonary Bypass (CPB)

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-03-31

Study Completion Date

2014-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Pharmacokinetics Cardiopulmonary Bypass Children

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

age less than or equal to 2 years

No interventions assigned to this group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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

Maximum Eligible Age

2 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Kevin Watt, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Duke University Hospital

Durham, North Carolina, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

K24HD05873505

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Pro00049942

Identifier Type: -

Identifier Source: org_study_id