Understanding Dexmedetomidine in Neonates After Open Heart Surgery (Dex)
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|ClinicalTrials.gov Identifier: NCT00576381|
Recruitment Status : Completed
First Posted : December 19, 2007
Results First Posted : April 11, 2013
Last Update Posted : April 18, 2013
|Condition or disease||Intervention/treatment||Phase|
|Tetrology of Fallot Heart Ventricle Hypoplastic Left Heart||Drug: Dexmedetomidine||Phase 1|
This is a single center, dose escalation study of a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours in neonates who are immediately post-op from cardiac surgery, and require tracheal intubation with mechanical ventilation in the post-op period.
Pediatric populations may benefit from the favorable pharmacodynamic effects of this medication.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||30 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Neonates Following Open Heart Surgery|
|Study Start Date :||April 2006|
|Actual Primary Completion Date :||December 2010|
|Actual Study Completion Date :||December 2010|
Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery.
Dosage Level 1=0.25mcg/kg loading dose, 0.2 mcg/kg/hr infusion Dosage Level 1A= 0.35mcg/kg loading dose, 0.3 mcg/kg/hr infusion Dosage Level 2= 0.5mcg/kg loading dose, 0.4 mcg/kg/hr infusion
Other Name: Precedex
- PK Profile of Dexmedetomidine [ Time Frame: A sparse PK sampling method was utilized. Between 6-12 PK samples were drawn : After start of infusion (0.5, 4-6, 8 hours), immediately prior to end of infusion and following end of infusion (0.25, 0.5, 1, 2-4, 6-8, 10-12 & 18hrs) ]This study measured the concentration of dex in the body and used those concentrations to determine how quickly the body metabolizes and eliminates dex(concentration-time or pharmacokinetic profile).The concentration of dex in the body is determined through serial blood sampling while administering dex and following discontinuation.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00576381
|United States, Pennsylvania|
|The Children's Hospital of Philadelphia|
|Philadelphia, Pennsylvania, United States, 19104|
|Principal Investigator:||Felice Su, MD||Children's Hospital of Philadelphia|