Pharmacokinetics/Pharmacodynamics of the Sedatives, Analgesics and Antibiotics in Patients Receiving Extracorporeal Membrane Oxygenation (ECMO)
试验速览
- 阶段
- 不适用
- 入组人数
- 36
- 试验地点
- 3
- 主要终点
- Minimum Plasma Concentration [Cmin]
研究概览
简要总结
It is a multi-center, open-label, observational study aimed to understand the pharmacokinetics and pharmacodynamics of the commonly used sedative, analgesic and antibiotic drugs in adult patients supported with extracorporeal membrane oxygenation (ECMO), by measuring the plasma concentrations and the clinical effect of dexmedetomidine, midazolam, butorphanol, remifentanil, sufentanil, propofol, linezolid, tigecycline, teicoplanin, caspofungin, voriconazole and meropenem.
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
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient given the sedatives, analgesics and antibiotics of interest during ECMO.
- •Age from 18 to 85 years old.
- •Multiple blood sampling is acceptable.
排除标准
- •Patients who are allergic to the investigated drugs.
- •Patients who are pregnant.
研究组 & 干预措施
Model building group
The data from the patients in the model building group will be used to build the population PK/PD model. Two to six blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO.
干预措施: The Sedatives, analgesics and antibiotics (Drug)
Model validation group
The data from the patients in the model building group will be used to build the population PK/PD model. Two to three blood samples will be collected during at least one dose interval at the steady-state, including one sample from the start of ECMO and one at the end of ECMO.
干预措施: The Sedatives, analgesics and antibiotics (Drug)
结局指标
主要结局
Minimum Plasma Concentration [Cmin]
时间窗: Up to 24 hours.
The minimum plasma concentration (the trough concentration), usually collected before the next dose.
Area Under the Curve [AUC]
时间窗: Up to 24 hours.
The area under the curve during the dose interval. It also can be calculated by the dose and the clearance of the drug.
Maximum Plasma Concentration [Cmax]
时间窗: Up to 24 hours.
The maximum plasma concentration, usually at the end of the infusion during an dose interval.
次要结局
- ICU mortality(Up to 60 days.)
- Hospital mortality(Up to 60 days.)
- Mechanical ventilation duration(Up to 60 days.)
- ICU length of stay (LOS)(Up to 60 days.)