Comparison of a Tissue Perfusion Guided Hemodynamic Protocol With a Conventional Hemodynamic Protocol in Septic Shock Patients: a Prospective, Randomised, Controlled Study
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Vasopressor Duration
研究概览
简要总结
The Surviving Sepsis Campaign (SSC) published 2008 revised guidelines to improve survival of septic shock patients. For hemodynamic stabilization the SSC recommends distinct treatment goals. The study hypothesis is that a tissue perfusion guided protocol could reduce the duration on vasopressor treatment compared to a conventional protocol.
详细描述
Background
Septic shock is a frequent and severe entity with a mortality of 55%. The Surviving Sepsis Campaign (SSC) published 2008 revised guidelines to improve survival of septic shock patients.
For hemodynamic stabilization the SSC recommends as treatment goals a mean arterial blood pressure > 65mmHg (MAP), a central venous blood pressure of 8-12 mmHg, a mixed venous oxygen saturation >65%, a central venous oxygen saturation > 70% and a diuresis > 0.5 ml/kg/h (1). According to the SSC guidelines a MAP > 65 mmHg should be aimed because at this blood pressure level tissue perfusion is preserved. This is based on a study in ten septic shock patients where norepinephrine was titrated to three levels (65, 75 and 85 mmHg) and the authors concluded that parameters of tissue perfusion did not differ between the each level (2).
Objective
To evaluate if a hemodynamic protocol guided by parameters of tissue perfusion could reduce the duration of vasopressor treatment in septic shock patients.
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
- •2 or more SIRS criteria according to ACCP/SCCM definition
- •Documented infection or strong suspicion of infection with adequate antibiotic treatment
- •Shock according to ACCP/SCCM definition with the necessity of vasopressor treatment
排除标准
- •Patients admitted with central nervous diseases
- •ST elevation myocardial infarction
- •Pulmonary embolism
- •Out of hospital cardiac arrest patients
- •Patients with therapy limitations
- •Known pregnancy
- •Inclusion in other interventional trials
研究组 & 干预措施
Tissue perfusion guided protocol
Active comparator group, where parameters of tissue perfusion are used to guide hemodynamic therapy
干预措施: Tissue perfusion guided protocol (Other)
Usual Care
Usual Care
干预措施: Usual Care (Other)
结局指标
主要结局
Vasopressor Duration
时间窗: 28 days
次要结局
- Organ failure free days(28 days)
- Catecholamine related adverse events(28 days)
- ICU length of stay(28 days)
- Catecholamine dose(28 days)