Understanding Dexmedetomidine in Neonates After Open Heart Surgery
Completed · Phase 1
Conditions studied: Tetrology of Fallot, Heart Ventricle, Hypoplastic Left Heart
In brief
The purpose of this study is to determine what happens to dexmedetomidine in the body after it has been given to a newborn after heart surgery. We want to learn how long the drug stays in the body, how the drug is metabolized by the body, and how well the medicine works at a particular dose or amount.
Key facts
- Study ID
- NCT00576381
- Run by
- Athena Zuppa
- People needed
- 30
- Starts
- 2006-04-01
- Expected to finish
- 2010-12-01
- Last updated by the study team
- 2013-04-18
Who can join
Age: any, up to 0. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Patients must be less than or equal to 1 month old.
- Postconceptual age must be > or equal to 37 weeks on the day of surgery.
- Postoperative from cardiac surgery with tracheal intubation/mechanical ventilation in the immediate post-op period.
- Planned tracheal extubation within 24 hrs post-op.
- Adequate renal function (serum creatine < or equal to 1.5mg/dL)
- Adequate liver function (ALT < or equal to 165 U/L)
- Isolated heart surgery
- Informed consent
You may not qualify if…
- Patients who have received another investigational drug since birth.
- Patients receiving continuous infusions of muscle relaxants in the post-op setting.
- Pateints who have a positive blood culture without a subsequent negative culture of other evidence of ongoing serious infection.
- Patients who show signs and symptoms of elevated intracranial pressure.
- Post-op hypotension defined by post conceptual age.
- Pre-existing bradycardia defined by age
- Heart block
- Weight < 2kg
- 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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