A Phase I Study of Dexmedetomidine Bolus and Infusion in Corrective Infant Cardiac Surgery: Safety and Pharmacokinetics

Carelon Research4 个研究点分布在 1 个国家目标入组 119 人开始时间: 2014年4月2日最近更新: 2018年3月23日

适应症

干预措施

试验速览

阶段: 1 期
状态: 已完成
发起方
入组人数: 119
试验地点: 4
主要终点: The occurrence of a safety event that is possibly, probably or definitely related to DEX administration

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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 corrective cardiac surgery that requires the use of cardiopulmonary bypass for congenital cardiac problems. This study will also design and validate a dosing schema for the use of DEX as described above.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Single Group
主要目的: Treatment
盲法: None

入排标准

年龄范围: — 至 180 Days（Child）
性别: All
接受健康志愿者: 否

入选标准

•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.

排除标准

•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).
•Enrollment in the PHN Collaborative Learning Study, if tetralogy of Fallot 91-180 days of age only.
•Known or suspected hepatic dysfunction; AST and ALT >3X upper limit of normal at the time of screening within 72 hours of operation.
•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.
•Preoperative administration of DEX or clonidine within 72 hours of operation.
•Major congenital anomaly(ies) outside the cardiovascular system that in the investigator's opinion would potentially affect safety or pharmacokinetics.
•Preoperative central nervous system injury resulting in clinical signs and symptoms: coma, seizures, hemiparesis.
•Planned period of deep hypothermic circulatory arrest.
•History of second or third degree heart block.
•Sinus or junctional bradycardia below 80 BPM sustained for greater than 15 minutes within 72 hours of operation.
•Junctional rhythm sustained for greater than 15 minutes within 72 hours of operation.
•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.
•History of cardiac arrest or ECMO cannulation.