Status:
COMPLETED
A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Transposition of the Great Arteries
Tetralogy of Fallot
Eligibility:
All Genders
Up to 180 years
Phase:
PHASE1
Brief Summary
The purpose of this Phase I study is to determine the safety of a drug called dexmedetomidine (DEX) as part of a balanced general anesthetic and sedative strategy for neonates and infants undergoing c...
Eligibility Criteria
Inclusion
- Male or female, age 0 to 180 days at the time of surgery.
- Diagnosis of: D-transposition of the great arteries (with or without ventricular septal defect), or tetralogy of Fallot, or ventricular septal defect (with or without associated atrial septal defect and/or patent ductus arteriosus)
- Scheduled for complete corrective two-ventricle surgical repair with cardiopulmonary bypass.
Exclusion
- 1\. Less than 37 completed weeks' gestational age at birth for the Neonatal age group (0-21 days); less than 36 completed weeks' gestational age at birth for the Infant age group (22-180 days).
- 2\. Enrollment in the PHN Collaborative Learning Study, if tetralogy of Fallot 91-180 days of age only.
- 3\. Known or suspected hepatic dysfunction; AST and ALT \>3X upper limit of normal at the time of screening within 72 hours of operation.
- 4\. Known or suspected renal dysfunction; serum creatinine \> 0.8 mg/dL after 7 days of age, \>1.2 mg/dL if \<7 days of age, within 72 hours of operation.
- 5\. Preoperative administration of DEX or clonidine within 72 hours of operation.
- 6\. Major congenital anomaly(ies) outside the cardiovascular system that in the investigator's opinion would potentially affect safety or pharmacokinetics.
- 7\. Preoperative central nervous system injury resulting in clinical signs and symptoms: coma, seizures, hemiparesis.
- 8\. Planned period of deep hypothermic circulatory arrest. 9. History of second or third degree heart block. 10. Sinus or junctional bradycardia below 80 BPM sustained for greater than 15 minutes within 72 hours of operation. 11. Junctional rhythm sustained for greater than 15 minutes within 72 hours of operation.
- 12\. Hypotension defined as mean arterial blood pressure below 35 mm Hg for 0-21 day old neonatal patients, and below 40 mm Hg for 22-180 day old infant patients sustained for greater than 15 minutes within 72 hours of operation.
- 13\. History of cardiac arrest or ECMO cannulation.
Key Trial Info
Start Date :
April 2 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2017
Estimated Enrollment :
119 Patients enrolled
Trial Details
Trial ID
NCT01915277
Start Date
April 2 2014
End Date
October 17 2017
Last Update
March 23 2018
Active Locations (4)
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1
Boston Children's Hospital
Boston, Massachusetts, United States, 02111
2
University of Michigan
Ann Arbor, Michigan, United States, 48109
3
Childrens Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
4
Texas Children's Hospital
Houston, Texas, United States, 77030