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临床试验/NCT04701099
NCT04701099Unknown不适用

Population Pharmacokinetics of Vancomycin, Meropenem, Milrinone, Dexmedetomidine and Fentanyl in Pediatric Patients During Extracorporeal Membrane Oxygenation

Yonsei University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2020年6月7日最近更新:
适应症

试验速览

阶段
不适用
入组人数
50
试验地点
1
主要终点
Pharmacokinetic parameter: Volume of distribution

研究概览

简要总结

Extracorporeal membrane oxygenation (ECMO) has been used primarily in newborns since it was first successfully implemented in the 1970s, and has recently increased use in infants and young children. Venoarterial ECMO (VA-ECMO) is a temporary mechanical circulatory support for patients with cardiac failure. Because ECMO is invasive, appropriate use of antimicrobial agent, analgesic and sedatives is important to promote recovery. However, a large variability in drugs pharmacokinetics is expected in pediatric ECMO patients due to the combination of ECMO, drug characteristics and disease factor. This study aimed to evaluate whether the PK of drugs is influenced by VA-ECMO and to recommend the optimal dosing strategies for proposed drugs in pediatric patients receiving VA-ECMO.

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 Years 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • <19 years old
  • receiving VA ECMO in Severance Hospital, Yonsei University Health System.
  • receiving one of these drugs: vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl
  • agreed to participate

排除标准

  • receiving drugs that could affect study drug's concentration due to drug-drug interaction

结局指标

主要结局

Pharmacokinetic parameter: Volume of distribution

时间窗: Between day0 to day3 after weaning off ECMO

Volume of distribution of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl

Pharmacokinetic parameter: Clearance

时间窗: Between day0 to day3 after weaning off ECMO

Clearance of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl

Serum or plasma concentration

时间窗: Between day0 to day3 after weaning off ECMO

Serum or plasma concentration of vancomycin or meropenem or milrinone or dexmedetomidine or fentanyl

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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