NCT00489138终止4 期
Prospective, Open-label Study of Pharmacokinetics of Ertapenem in the Muscle Using Microdialysis in Mechanically Ventilated Intensive Care Unit Patients, Treated or Not by Norepinephrine
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- assess the tissular and plasma kinetics of ertapenem
研究概览
简要总结
Goal of study:
To assess the tissular and plasma kinetics of ertapenem;
To determine the optimal dosages in the patients according to norepinephrine administration:
- to assess muscular diffusion of free form of ertapenem after administration to mechanically ventilated patients requiring such a treatment. The patients are included in the groups "with norepinephrine" or "without norepinephrine" according to their hemodynamic status.
- to assess the plasma pharmacokinetics of ertapenem in mechanically ventilated patients treated or not by norepinephrine.
Open-label, prospective study performed in a single ICU (16 beds) of a tertiary hospital (700 beds).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •18 years and more
- •negative pregnancy test
- •HIV/HBV, HCV negative tests
- •Mechanical ventilation with pneumonia or intraabdominal infection requiring ertapenem
排除标准
- •refractory septic shock requiring use of additional catecholamines
- •patients with positives tests for HIV, HBV, HCV
- •pregnant females
- •allergic insufficiency
- •hemodiafiltration
- •contraindication to microdialysis catheter set-up
- •severe arteritis of lower extremities
- •treatment with vasodilatators
- •prior history of aorto-iliac shunt
- •involvement in a clinical trial in the last three months
- •exclusion from national records
- •non affiliated to "securité sociale"
研究组 & 干预措施
1
Experimental
Noradrenalin infusion
干预措施: Ertapenem (Drug)
结局指标
主要结局
assess the tissular and plasma kinetics of ertapenem
时间窗: 24 months
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
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