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临床试验/NCT03922451
NCT03922451终止不适用

Pharmacokinetics of Antibiotics 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 4 人开始时间: 2019年8月27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
终止
入组人数
4
试验地点
1
主要终点
Plasma concentration: cefazolin

研究概览

简要总结

This study will measure plasma concentrations of piperacillin-tazobactam and cefazolin in pediatric patients supported with extracorporeal membrane oxygenation (ECMO) aiming to better understand the pharmacokinetics of these medications in this in vivo 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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • supported on ECMO
  • receive piperacillin-tazobactam or cefazolin as part of routine care or infection management

排除标准

  • >= 18 years
  • No Consent provided

研究组 & 干预措施

Pediatric patients supported on ECMO

干预措施: piperacillin-tazobactam (Drug)

Pediatric patients supported on ECMO

干预措施: Cefazolin (Drug)

结局指标

主要结局

Plasma concentration: cefazolin

时间窗: Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.

Drug levels will be checked at baseline followed by additional measurements after the dose based on the dosing intervals but anticipated to be 30, 60, 120, 360, 480 minutes after the dose. Dosing regime will be q8-12 hourly pending end organ function (at the discretion of the treating team). The study will be continued for the duration of the Antibiotic therapy whilst on ECMO support and for one set of samples following decannulation.

Plasma concentration: piperacillin-tazobactam

时间窗: Peri drug dose administration until cessation of antibiotic therapy or cessation of ECMO support up to a maximum of 4 weeks.

Drug levels will be checked at baseline followed by additional measurements after the dose based on the dosing intervals but anticipated to be 30, 60, 120, 360, 480 minutes after the dose. Dosing regime will be q8-12 hourly pending end organ function (at the discretion of the treating team). The study will be continued for the duration of the Antibiotic therapy whilst on ECMO support and for one set of samples following decannulation.

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

Katie Moynihan

Cardiac Intensivist

Boston Children's Hospital

研究点 (1)

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