Hemodynamic Optimisation Guided With Transcranial Doppler in Septic Shock
试验速览
- 阶段
- 不适用
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- mortality at day 28
研究概览
简要总结
Randomized, controlled, prospective trial, including ICU patients with Sepsis or septic Shock, at the early phase.
patients will be randomized in 2 groups regarding the hemodynamic management and catecholamin doses:
- Group 1: standard hemodynamic goals and catecholamin infusion to achieve: mean arterial pressure > or equal to 65 mmHg and diastolic arterial pressure > ou equal to 50 mmHg within the first 60 minutes.
- Group 2: personalized hemodynamic goals and catecholamin infusion until normal transcranial doppler: IP<1,2.
详细描述
Randomized, controlled, prospective trial, including ICU patients with Sepsis or septic Shock, at the early phase.
patients will be randomized in 2 groups regarding the hemodynamic management and catecholamin doses:
- Group 1: standard hemodynamic goals and cathecolamin infusion to achieve: mean arterial pressure > or equal to 65 mmHg and diastolic arterial pressure > ou equal to 50 mmHg within the first 60 minutes.
- Group 2: personalized hemodynamic goals and cathecolamin infusion until normal transcranial doppler: IP<1,2.
For the 2 groups, standard management including: microbiological sampling, early broad spectrum anti infective therapy, fluid management and decreasing of blood lactate levels, will be aimed within the first 60 minutes.
For the Group 2 patients: personalized hemodynamic management will be maintained during 72 hours.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 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
- •All ICU patients presenting septic shock
- •No criteria of traumatic or vascular brain injury
排除标准
- •Patients with refractory septick shock
- •rapid fatal evolution: before 72 hours
- •No individualisation of the MCA ultrasonographic window
研究组 & 干预措施
Standard Group
standard hemodynamic goals and catecholamin infusion to achieve: mean arterial pressure > or equal to 65 mmHg and diastolic arterial pressure > ou equal to 50 mmHg within the first 60 minutes.
personalized hemodynamic goals Group
Personalized hemodynamic goals and catecholamin infusion to achieve normal cerebral perfusion assessed by transcranial doppler: PI < 1,2.
干预措施: hemodynamic optimisation aiming to achieve normal cerebral perfusion (Procedure)
结局指标
主要结局
mortality at day 28
时间窗: 28 days after ICU admission
Mortality at day 28
次要结局
- Incidence of sepsis associated encephalopathy(28 days after ICU admission)
- Incidence of sepsis related organ failures(28 days after ICU admission)
- Length of ICU stay(30 days after end of randomization)
研究者
Mhamed Sami Mebazaa
Professor head of the anesthesia and intensive care department
Mongi Slim Hospital