Diagnostic and Prognostic Evaluation of Vasorin During Septic Shock
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 144
- 试验地点
- 2
- 主要终点
- Vasn plasma concentration at D0 for each group
研究概览
简要总结
Septic shock is the most severe form of infection. Currently, an early specific biomarker for septic shock is needed. Remember that shock situations are numerous, not only septic (eg hemorrhagic, cardiogenic...), and also accompanied by a severe pro-inflammatory state that it is sometimes difficult to distinguish from a septic state. Procalcitonin (PCT) is the most studied biomarker but still lacks sensitivity (77%) and specificity (79%). The investigators hypothesize that the Vasn could become this potential new biomarker and would allow a better diagnosis and thus the need or not to treat patients with antibiotics. The laboratory studies suggest a link between Vasn and septic shock. The goal of this project is to measure and compare plasma Vasn concentrations in 2 groups of patients = group 1: septic shock versus group 2: non-septic shock. Briefly, shock is defined as low blood pressure requiring vasopressor agents with confirmed infection (group 1) or without suspected infection such as patients admitted in intensive care unit post cardiac surgery with CBP (group 2). The investigators will also assess patient 28-day mortality to identify Vasn as a potential prognostic biomarker.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 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
- •Adults over 18 years.
- •Patients admitted for less than 24 hours in intensive care unit of the CHU Amiens Picardie.
- •Group 1: patients with septic shock defined by sepsis with 2 mmol/l Lactates, requiring vasopressors to maintain mean blood pressure at 65 mmHg (despite adequate vascular filling) in the presence of fever (T°>38.3) with a documented or suspected infection
- •Group 2: patients with a shock defined by arterial hypotension requiring the use of vasopressors with 2 mmol/l Lactates but without suspected infection and apyrexie (T°<38°). For example: vasoplegia post cardiac surgery with CBP or cardiogenic shock or hemorrhagic shock
排除标准
- •Pregnant women
- •Group 1 : No evidence of suspected or documented infection
- •Group 2 : Presence of fever and/or suspected infection
研究组 & 干预措施
in septic shock (infection)
干预措施: blood sample (Biological)
in shock without sepsis (without infection)
干预措施: blood sample (Biological)
结局指标
主要结局
Vasn plasma concentration at D0 for each group
时间窗: day 0
Vasn plasma concentration in each group
时间窗: day 3
Correlation between Vasn plasma concentration and noradrenaline dose peak in each group
时间窗: day 3
Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group
时间窗: day 3
Correlation between Vasn plasma concentration and coagulation marker concentration in each group
时间窗: day 3
coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers
Correlation between Vasn plasma concentration and mortality in each group
时间窗: day 1
Correlation between Vasn plasma concentration and SOFA score at admission in each group
时间窗: day 3
Correlation between Vasn plasma concentration and length of hospitalization in each group
时间窗: day 3
Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group
时间窗: day 3
Vasn plasma concentration in each group
时间窗: day 1
Correlation between Vasn plasma concentration and noradrenaline dose peak in each group
时间窗: day 0
Correlation between Vasn plasma concentration and noradrenaline dose peak in each group
时间窗: day 1
Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group
时间窗: day 0
Correlation between Vasn plasma concentration and occurrence of an IRA (KDIGO score) in each group
时间窗: day 1
Correlation between Vasn plasma concentration and coagulation marker concentration in each group
时间窗: day 0
coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers
Correlation between Vasn plasma concentration and coagulation marker concentration in each group
时间窗: day 1
coagulation marker are TF, platelet count, TP, TCA, Factor V, fibrinogen, D-dimers
Correlation between Vasn plasma concentration and SOFA score at admission in each group
时间窗: day 0
Correlation between Vasn plasma concentration and SOFA score at admission in each group
时间窗: day 1
Correlation between Vasn plasma concentration and mortality in each group
时间窗: day 3
Correlation between Vasn plasma concentration and mortality in each group
时间窗: day 0
Correlation between Vasn plasma concentration and length of hospitalization in each group
时间窗: day 1
Correlation between Vasn plasma concentration and length of hospitalization in each group
时间窗: day 0
Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group
时间窗: day 0
Correlation between Vasn plasma concentration and plasma level of procalcitonin in each group
时间窗: day 1
次要结局
未报告次要终点