Early Detection of Glycocalyx Damage in Emergency Room Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 260
- 试验地点
- 1
- 主要终点
- Correlation of glycocalyx thickness with clinical course.
研究概览
简要总结
Aim of the study is to evaluate to what extent a glycocalyx damage measured in the ER in patients presenting with sepsis correlates with their clinical course and if it can be used as a clinical stratification tool and mortality predictor.
The study will focus on the changes of the microcirculation and how they correlate with the macrocirculation, as well as microbiologic parameters. In the study will participate ca. 300 patients with sepsis, as well as 30 patients without sepsis and 30 healthy individuals.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Patients with suspected sepsis
- •Adult patients presenting to the ER with the clinical suspicion of infection
- •Indication for hospital admission
- •Patients without sepsis
- •Adult patients presenting to the ER with other conditions apart from sepsis/infection.
- •Healthy individuals
- •Adult healthy individuals.
- •Exclusion Criteria (for all groups):
- •Underage persons
- •Pregnant women
- •Oral mucosal injuries
排除标准
- 未提供
结局指标
主要结局
Correlation of glycocalyx thickness with clinical course.
时间窗: At time of presentation in the ER.
Glycocalyx thickness measured with the use of GlycoCheck System (Perfused Boundary Region - PBR, in µm) will be correlated with patients' clinical course (e.g. with the use of SOFA score - pts.).
次要结局
- Correlation of glycocalyx thickness with major events.(Hospital stay, an expected average of 4 weeks.)
- Correlation of glycocalyx thickness with 90-day mortality.(Up to 90 days.)
- Correlation of glycocalyx thickness with subsequent organ failure.(Hospital stay, an expected average of 4 weeks.)