Pharmacokinetics of Antibiotics, Sedative and Analgesic During Extracorporeal Membrane Oxygenation
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- The median observed through concentration(Cmin)
研究概览
简要总结
The main purpose of the present study is to investigate the risk factors that affect drug pharmacokinetic (PK) during extracorporeal membrane oxygenation (ECMO). To advance understanding of PK variance and improve the patients outcomes during ECMO.
详细描述
Ex vivo experiments for drug stability testing and ECMO circuits testing in animal models.PK studies in healthy animals and critically ill animal models with or without ECMO to define the PK alterations. Clinical PK studies in critically ill patients on ECMO.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who are undergoing ECMO for respiratory and or cardiac dysfunction
- •Clinical indication for the antibiotics
- •Clinical indication for the sedatives and analgesics
排除标准
- •No consent
- •Known allergy to study drug
- •Pregnancy
- •Massive fluid resuscitation (>50% blood volume transfused) in the previous 8 hours.
- •Therapeutic plasma exchange in the preceding 24 hours
结局指标
主要结局
The median observed through concentration(Cmin)
时间窗: one-dose period
Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs
The median observed peak concentration(Cmax)
时间窗: one-dose period
Using liquid chromatography-mass spectrometry to evaluate the concentration of study drugs
Volume of distribution(Vd)
时间窗: one-dose period
PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
Clearance(CL)
时间窗: one-dose period
PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
Area under the plasma concentration versus time curve (AUC)
时间窗: one-dose period
PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
Inter-compartmental clearance (Q)
时间窗: one-dose period
PK data were analyzed with a nonlinear mixed-effect modeling approach using NONMEM version 7.2.0
次要结局
- Development of strategies for drug administration in critically ill patients receiving ECMO(one-dose period)
研究者
Qingyuan Zhan
Prof.
China-Japan Friendship Hospital