Microcirculation Guided Therapy Versus "Standard Treatment" of Severe Sepsis
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 80
- 试验地点
- 2
- 主要终点
- Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis
研究概览
简要总结
The purpose of this study is to asses the recovery of organ failure between two resuscitation protocols in severe sepsis: standard, pressure guided therapy versus a microcirculation guided therapy
详细描述
Despite continued improvements in medical therapy, mortality from septic shock has remained between 30% and 70% for the past three decades with only a slight decrease in mortality rate. Standard treatment of septic shock is fluid resuscitation, followed by agents with vasopressor activity to correct hypotension in septic shock. The question rises whether vasopressors should be the first line of action in septic shock Opening and recruiting the microcirculation are expected to improve regional organ function and tissue distress in severe sepsis. Beside fluid resuscitation, vasodilatation, in this respect, enhances microcirculatory flow while vasoconstriction causes a reduction in microcirculatory flow. On the other hand, a minimal perfusion pressure should be present. Our aim is to asses the effects of two resuscitation protocols in severe sepsis: the "standard treatment" using predefined pressure goals versus a microcirculation guided therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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
- •age 18 years or older
- •admission to the intensive care unit with severe sepsis, defined in according with a modification of the American College of Chest Physician/SCCM guidelines criteria
- •intention to provide full intensive care treatment for at least 72 hours and
- •written informed consent to be obtained from patient or next of kin.
排除标准
- •haematologic malignancy
- •metastatic malignancy
- •AIDS with CD4 < 50 cells/mm3
- •liver cirrhosis Child Pugh B & C
- •pregnancy
- •post resuscitation with GCS < 8 of 15 and treatment with induced hypothermia
结局指标
主要结局
Difference in SOFA (Sequential Organ Failure Assessment) score during the first 72 hours of treatment for severe sepsis
时间窗: 72 hours
次要结局
- ICU and hospital length of stay(hospital stay)
- Severity, decrease and duration of organ failure over the complete ICU stay(complete icu stay)
- Duration of organ support(during ICU treatment)
- ICU and hospital mortality(hospital stay)
- Plasma concentration of asymmetric dimethyl arginine (ADMA(72 hours)
- Inflammatory response measured by IL-6/IL-10(72 hours)