Comparison of a Tissue Perfusion Guided Hemodynamic Protocol With a Standard Hemodynamic Protocol in Septic Shock Patients
Comparison of a Tissue Perfusion Guided Hemodynamic Protocol With a Conventional Hemodynamic Protocol in Septic Shock Patients: a Prospective, Randomised, Controlled Study
研究概览
详细说明
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.
Methods
Patients suffering from septic shock requiring vasopressor support are randomly assigned to a control group (usual care) and an intervention group (tissue perfusion guided protocol). In the intervention group parameters of tissue perfusion are used to guide hemodynamic therapy.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
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Canton of Bern
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Bern、Canton of Bern、瑞士、3010
- Department of Intensive Care Medicine, Bern University Hospital
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 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
Exclusion Criteria
- 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
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:并行分配
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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其他:日常护理
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日常护理
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有源比较器:Tissue perfusion guided protocol
Active comparator group, where parameters of tissue perfusion are used to guide hemodynamic therapy
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A tissue perfusion guided protocol is used to guide hemodynamic therapy
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研究衡量的是什么?
主要结果指标
结果测量 |
大体时间 |
|---|---|
|
Vasopressor Duration
大体时间:28 days
|
28 days
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次要结果测量
结果测量 |
大体时间 |
|---|---|
|
ICU住院时间
大体时间:28天
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28天
|
|
Organ failure free days
大体时间:28 days
|
28 days
|
|
Catecholamine dose
大体时间:28 days
|
28 days
|
|
Catecholamine related adverse events
大体时间:28 days
|
28 days
|
合作者和调查者
调查人员
- 学习椅:Jukka Takala、Department of Intensive Care Medicine, Bern University Hospital
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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