Investigations of New Markers in Patients With Shock
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Demonstrate the superiority of at least one of 3 markers (HIF, MPs, cDNA) with regard to plasma lactate level for evaluating the treatment response in patients with shock
研究概览
简要总结
Shock is a severe deficiency in oxygen at the cell level which could lead to the death.The study was aimed at finding markers of treatment response in patients with shock, with a better accuracy than that of lactate actually used : hypoxia-inducible factor (HIF), circulating DNA (cDNA), and plasma from cells (MPs).
详细描述
Shock is a severe deficiency in oxygen at the cell level which could lead to the death. The treatment strategy relies on the profile of plasma lactate level, which the kinetics and metabolism are inadequate for evaluating the treatment efficiency without delay. Hence, it is now critical to identify adequate markers of dysoxia.
The study was aimed at finding markers of treatment response in patients with shock, with a better accuracy than that of lactate.To this purpose, a multiple approach is undertaken with the analysis of 3 independent markers of cellular ischemia : hypoxia-inducible factor (HIF), circulating DNA (cDNA), and plasma from cells (MPs). Indeed, the characteristics of HIF as marker of cell dysoxia, and MPs as markers of cell apoptosis, combined with cDNA seem providing complementary information in order to describe the consequences of shock as well as the response to treatment.
Samples of patients will be collected (from rest of blood sample collected for other measurements) at each step of the management of these patients. The evolution of these markers will be compared with that of lactate plasma levels (standard of care). Subgroup analysis will be undertaken in relation with the cause of shock state (septic, cardiogenic, hemorrhagic).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •shock state defined by a rise of plasma lactate level (> 2 mmol/L)and/or refractory low blood pressure in the volume expansion requiring an introduction of catecholamines
- •admission in intensive care < 6 hours
排除标准
- •Pregnancy
- •presumed survival lower than 48 hours
- •absence of central venous way and arterial catheter
结局指标
主要结局
Demonstrate the superiority of at least one of 3 markers (HIF, MPs, cDNA) with regard to plasma lactate level for evaluating the treatment response in patients with shock
时间窗: 2 years
次要结局
- Improve the physiopathological knowledge of the patients with shock(2 years)