Disruption of Circadian Rhythm and Healthcare-related Infection in Patients With Severe Trauma
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- area under the curve representing the maximal expression of Bmal1 gene during the first 24 h following inclusion
研究概览
简要总结
Circadian rhythms, which play crucial roles in physiology, are emerging as important regulators of specific immune functions. Hospitalization in intensive care unit leads to a deep impairment of circadian rhythm. Infection is a frequent event during ICU hospitalization.
The investigators hypothesis is that in trauma patients the lack of circadian rhythm variations is associated with the occurrence of infection. The primary aim of the study is to assess the circadian variations of plasma Bmal1 in the occurrence of healthcare related infection during the 30 days after inclusion. The secondary aims are to assess the plasma expression of circadian genes (Clock, Cry1, Per3, and Rev-erba), the production of cytokines in plasma, and the concentration of cortisol, according to the occurrence of an infection.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Trauma patients with an injury severity score > 15, requiring mechanical ventilation for at least 24 h during the first 48 h and an arterial catheter.
排除标准
- •Pregnant and lactating women
研究组 & 干预措施
trauma patients
Blood samples will be collected every 4 hours during 24 h, between day 2 and day 4 after inclusion
干预措施: blood samples (Other)
结局指标
主要结局
area under the curve representing the maximal expression of Bmal1 gene during the first 24 h following inclusion
时间窗: 24 hours
次要结局
未报告次要终点