Contribution of Pre-hospital Blood Lactate Level for Pre-hospital Orientation of Septic Shock
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Mortality after inclusion
研究概览
简要总结
In the pre-hospital setting, the severity assessment of septic shock is essential to decide the optimal initial in-hospital level of care. As clinical signs can be faulted, there is a need for an additional element in order to enhance the severity assessment and to decide in-hospital admission in the intensive care unit (ICU) or in the emergency department (ED). Point of care medical device yielding blood lactate levels since the pre-hospital setting may give an easy and valuable element for the severity assessment and the decision-making.
The aim of this study is to provide clinical evidence that the pre-hospital blood lactate level predicts the 30-day mortality of patients with septic shock.
详细描述
This trial is a prospective, observational, non-randomized controlled study. A total of 1000 patients requiring mobile intensive care unit intervention for a septic shock in the pre-hospital setting will be included. Pre-hospital blood lactate levels will not be taken into account to decide patients treatments and/or ED or ICU admission. In the pre-hospital setting, each patient will benefit from 2 measurements of blood lactate level: initial measurement at the first contact, and final measurement at the hospital admission with a specific point of care medical device.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age > 18 years either sex
- •Severe sepsis according to the French anesthesiology and intensive care society (SFAR) and intensive care society (SRLF) conference 2005 defined by the existence of an infectious disease and at least one the following:
- •Low blood pressure prior to volume expansion
- •Glasgow coma scale < 13
- •Skin mottling score > 2
- •Septic shock according to the French anesthesiology and intensive care society (SFAR) and intensive care society (SRLF) conference 2005 definition
排除标准
- •Age < 18 years
- •Pregnancy
- •Serious comorbid conditions with a not to be reanimated status known since pre-hospital setting
- •Patients with guardianship or curator
结局指标
主要结局
Mortality after inclusion
时间窗: 30 days
mortality rate
次要结局
- Intensive Care Unit length of stay(90 days)
- Hospital length of stay(90 days)
- Mechanical ventilatory support(30 days)
- Hemodynamic support(30 days)
- Duration of hemodiaflitration(30 days)
研究者
Romain Jouffroy
PI
Hôpital Necker-Enfants Malades