The Pharmacokinetics and Pharmacodynamics of Dexmedetomidine in Neonates Following Open Heart Surgery
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- PK Profile of Dexmedetomidine
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 1 Hour 至 30 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
A
Neonates will be administered a single bolus dose of dexmedetomidine followed by a continuous infusion for up to 24 hours post cardiac surgery.
干预措施: Dexmedetomidine (Drug)
结局指标
主要结局
PK Profile of Dexmedetomidine
时间窗: 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.
次要结局
未报告次要终点
研究者
Athena Zuppa
Principal Investigator
Children's Hospital of Philadelphia