Comparing of Two Regimes (Fast and Slow) of Fluid Challenge on Glycocalyx Assessed by Perfused Boundary Region in Septic and Elective Major Surgical Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Influence of balanced crystalloid infusion time on endothelial glycocalyx
研究概览
简要总结
Interventional study comparing effect of two regimes of fluid challenge in patients with sepsis and in patients undergoing elective major surgery on glycocalyx by using perfused Boundary Region in sublingual microcirculation.
详细描述
Effect of two regimes of fluid challenge on GCX in patients with sepsis and during elective surgery under general anesthesia.
Hypothesis to be tested: Administration of 500 ml of balanced solution as a bolus impairs GCX more than prolonged administration.
The aim of the study: Comparison of two regimes of fluid challenge in patients with sepsis and in patients undergoing elective major surgery.
Type of the study: Open, randomized, interventional.
Subjects:
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
- Single (Investigator)
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
- •arm A: age over 18, diagnosis sepsis, fluid bolus administration indicated, arm B: age 18-70, ASA status I-III, major surgery
排除标准
- 未提供
研究组 & 干预措施
Patients with sepsis/septic shock
Comaprison of fast or slow fluid bolus administration in patients with sepsis/septic shock 48hours before admission to ICU requiring fluid challenge as assessed by clinical examination
干预措施: Fluid bolus administration (Drug)
Major surgical patients
Comaprison of fast or slow fluid bolus administration in patients undergoing major surgery requiring fluid challenge as assessed by clinical examination
干预措施: Fluid bolus administration (Drug)
结局指标
主要结局
Influence of balanced crystalloid infusion time on endothelial glycocalyx
时间窗: baseline and at 20, 40, 60 and 120 minutes
Change in the endothelial glycocalyx thickness by PBR method
次要结局
未报告次要终点
研究者
Vladimir Cerny
Principal Investigator
University Hospital Hradec Kralove