跳至主要内容
临床试验/NCT03593408
NCT03593408招募中不适用

Pharmacokinetics of Sedatives and Analgesics During Extracorporeal Membrane Oxygenation (ECMO) Support

Boston Children's Hospital1 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2019年2月8日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
招募中
入组人数
20
试验地点
1
主要终点
change in plasma concentrations of morphine

研究概览

简要总结

This study will measure plasma concentrations of dexmedetomidine, fentanyl, morphine and midazolam in pediatric patients supported with extracorporeal membrane oxygenation (ECMO) aiming to understand the pharmacokinetics of these drugs in this setting.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
0 Days 至 17 Years(Child)
性别
All
接受健康志愿者
否

入选标准

  • •supported on ECMO
  • •receiving one or a combination of the following drugs dexmedetomidine, fentanyl, midazolam or morphine as part of sedation management

排除标准

  • 未提供

研究组 & 干预措施

Pediatric Patients on ECMO Support

干预措施: Dexmedetomidine (Drug)

Pediatric Patients on ECMO Support

干预措施: Fentanyl (Drug)

Pediatric Patients on ECMO Support

干预措施: Midazolam (Drug)

Pediatric Patients on ECMO Support

干预措施: Morphine (Drug)

结局指标

主要结局

change in plasma concentrations of morphine

时间窗: Throughout the duration of sedation management with morphine at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped

Change in plasma concentrations of dexmedetomidine

时间窗: Throughout the duration of sedation management with dexmedetomidine at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped

change in plasma concentrations of fentanyl

时间窗: Throughout the duration of sedation management with fentanyl at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped

change in plasma concentrations of midazolam

时间窗: Throughout the duration of sedation management with midazolam at baseline, 30, 60, 120 minutes and then at 4, 6, 12 hours after each bolus or change in infusion and then at 30,60, 90, 120, 240minutes and 4 hours after the drug is stopped

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Viviane Nasr

Cardiac Anesthesiologist

Boston Children's Hospital

研究点 (1)

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