Status:
COMPLETED
A Pharmacokinetic Study of Dexmedetomine in Infants
Lead Sponsor:
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Conditions:
Cardiac Surgical Procedures
Eligibility:
All Genders
1-24 years
Phase:
PHASE1
Brief Summary
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 tr...
Detailed Description
This clinical trial of three dose rates of dexmedetomine will determine the pharmacokinetics of the drug in infants who remain tracheally intubated postoperatively. An exploratory pharmacodynamic stud...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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.
Key Trial Info
Start Date :
May 1 2004
Trial Type :
INTERVENTIONAL
End Date :
November 1 2006
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00459082
Start Date
May 1 2004
End Date
November 1 2006
Last Update
April 11 2007
Active Locations (1)
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1
The Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104