REAnimation Low Immune Status Markers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 552
- 试验地点
- 1
- 主要终点
- Percentage of patients meeting the definition of of injury-induced-immunosuppression
研究概览
简要总结
The fact that sepsis disrupts immune system homeostasis by inducing an initial cytokine storm, that participates to occurrence of organ failures and early death, followed by a compensatory anti-inflammatory response leading to immunosuppression, is now well established. This immunomodulating response results in a higher risk of secondary infections and is associated to 2/3 of deaths related to septic shocks. Follow up of patients' immune status with time is crucial to guide therapy management. Objective of REALISM project is to demonstrate existence of this immunosuppression phase, by providing strong epidemiologic data for septic shock patients, but also by extension to other situations of inflammatory aggressions like severe severe trauma or burns, or major surgery. This project will provide tools to predict occurrence of secondary infections and guide patient management by comparing innovating immunomonitoring tools to reference tests non already adapted to a routine patient management.
Targeted populations are adult patients hospitalized for septic shock, severe trauma (including severe burn) or major surgery and healthy volunteers, whom blood samples will serve to validate reference intervals of the two reference tests.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Blood sampling
Blood sampling will be performed in all patients and healthy volunteers
干预措施: Blood sampling (Biological)
结局指标
主要结局
Percentage of patients meeting the definition of of injury-induced-immunosuppression
时间窗: Up to 2 months after injury
The immunosuppression status will be determined from two immunological reference tests: (1) lymphocyte proliferation in response to ex vivo T cell stimulation (adaptive immunity) (Poujol et al., 2014) and (2) the production of tumor necrosis factor (TNF) by monocytes in response to ex vivo stimulation by lipopolysaccharide (LPS) (innate immunity) (Duffy et al., 2014). The values measured will be defined as normal or abnormal, depending on whether they are within reference intervals (RI) derived from an independent set of healthy volunteers. For this purpose, the definition of immunosuppression will be: an abnormal result in at least one of the two "reference" tests (outside the reference intervals defining normal values), and on at least two consecutive samples. The same reference test must be abnormal in two successive samples examined for the patient to be considered immunosuppressed.
次要结局
- Proportion of patients with a deficiency of the innate or adaptive immunity(Up to 2 months after injury)
- Comparison of performance of the reference tests and new biomarkers for the diagnosis of immunosuppression(Up to one week after injury)
- Comparison of immune status before and after surgery in the population of surgical patients(Up to 2 months after surgery)
- Correlation between the immunosuppression status and the incidence of healthcare-associated infections(Up to 28 days after injury)
- Correlation between immunosuppression and mortality(Up to 90 days after injury)