A Pharmacokinetic Study of Dexmedetomine in Infants

Completed · Phase 1

Conditions studied: Cardiac Surgical Procedures

In brief

Blind randomized trial of a single bolus dose of dexmedetomine followed by a continuous infusion (CIVI) for up to 24 hours in infants who immediately post-operative from cardiac surgery and require tracheal intubation with mechanical ventilation in the post-operative period. Three bolus and infusion dose will be administered to a total of 36 patients.

Key facts

Study ID: NCT00459082
Run by: Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
People needed: 36
Starts: 2004-05-01
Expected to finish: 2006-11-01
Last updated by the study team: 2007-04-11

Who can join

Age: 0 and older, up to 2. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

Greater than or equal to 1 month, less than or equal to 24 months
Post-operative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-operative period
Planned tracheal extubation within 24 hours post-operative period
Renal function-serum creatine = 1.5 times the ULN for age
Total bilirubin less than or equal to 1.5 X upper limit of normal (ULN) for age
SGPT (ALT) ,less than+ 3x upper limit of normal (ULN) for age
Signed written informed consent

You may not qualify if…

Patients who have received another investigational drug within the past 30 days
Receiving intermittent or continuous muscle relaxation during study period
Patients who have a positive blood culture without a subsequent negative culture or other evidence of ongoing serious infection.
Patients who in the opinion of the investigator may not be able to comply with the safety monitoring requirements of the study.
Post-Operative hypotension
Heart block
Weight < 5 kg
Patients who, in the opinion of the investigator, are not appropriate candidates for an investigational drug study.

Where it is running

The Children's Hospital of Philadelphia — Philadelphia, Pennsylvania, United States

Full record on ClinicalTrials.gov

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