A Pilot Pharmacokinetic Study of Antibiotics in Patients Assisted by Extracorporeal Membrane Oxygenation in Intensive Care Unit
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 45
- 主要终点
- Medium Antibiotics plasma concentration (CT 50)
研究概览
简要总结
The PHARMECMO study is a pilot, prospective, pharmacokinetic study, conducted in a cardiac surgery intensive care unit of 18 beds. Optimization of antibiotic therapy for extracorporeal membrane oxygenation (ECMO) patients remains a pharmacological challenge. Clinical studies suggest that individualized dosing strategies and therapeutic drug monitoring could facilitate the achievement of adequate antibiotic concentration. The objective of this pilot study was to observe the pharmacokinetic characteristics of commonly used antibiotics in intensive care for patients treated with extracorporeal membrane oxygenation.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age > 18 years
- •Extra corporeal membrane oxygenation treatment
- •Parenteral antibiotherapy for known or suspected sepsis
- •Informed consent
排除标准
- •Refusal of participation
- •Pregnancy
- •Burned patient
- •Steady state conditions not reached
- •Non-intravenous administration of antibiotherapy
结局指标
主要结局
Medium Antibiotics plasma concentration (CT 50)
时间窗: Up to 24 hours
Dosage under steady state conditions of every antibiotic plasma concentration in the middle of the interval between two administration (CT 50) in patients with sepsis and treated by ECMO
Minimum Antibiotics plasma concentration (Cmin) (C min)
时间窗: Up to 24 hours
Dosage under steady state conditions of every antibiotics plasma concentration just before the next administration in patients with sepsis and treated by ECMO
次要结局
未报告次要终点
研究者
Joe Elie Salem
MD, PhD
Groupe Hospitalier Pitie-Salpetriere