Prospective Study to Discover New Biomarkers for Early Detection of Sepsis and Prediction of Sepsis-related Mortality in Patients With Severe Community Acquired Pneumonia (sCAP)
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 3
- 试验地点
- 15
- 主要终点
- Detection of sepsis
研究概览
简要总结
This multi-center observational case-control study in Intensive Care Unit (ICU) patients is to identify novel biomarkers allowing to recognize severe community acquired pneumonia (sCAP) -associated sepsis at an earlier stage and predict sepsis-related mortality. Patients with sCAP (cases) will be profoundly characterized over time regarding the development of sepsis and compared with control patients. The mechanisms and influencing factors on the clinical course will be explored with most modern -omics technologies allowing a detailed characterisation. These data will be analysed using machine learning algorithms and multi-dimensional mathematical models.
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
- 否
入选标准
- •Admission to the ICU of one of the participating centers.
- •Cases: severe community acquired pneumonia with requirement for ICU admission.
- •Controls: Clinical phenotype of inflammation not due to suspected sepsis In addition, control patients will be patients with fever >38°C, CRP >100mg/L, no infection focus expected in ≥ 24h.
- •All required sample types can most likely be collected within the first 24h visits.
- •Expected ICU stay of more than 24h.
排除标准
- •Admission to the hospital within the prior 14 days.
- •Patients with psychosis
- •Evidence of a hospital acquired pneumonia.
- •One of the following respiratory conditions: Acute exacerbation of chronic obstructive pulmonary disease (COPD) or bronchiectasis, acute severe asthma, aspiration pneumonia, tuberculosis, clinical suspected viral pneumonia without bacterial infection, cardiogenic pulmonary oedema.
- •Patients with an acute respiratory distress Syndrome (ARDS).
- •Patient which can be managed as outpatients and do not require an ICU.
- •Patient where a transmission to another institution is likely within the next 24h.
- •Documented rejection of the general consent or participation to research in general.
- •Patients with a palliative situation and a life expectancy due to other diseases (e.g. progressed cancer) less than 28 days.
结局指标
主要结局
Detection of sepsis
时间窗: within 7 days after study inclusion
Sepsis detection based on new discovered digital biomarkers will be compared to classical sepsis-3 criteria (with an increase of the sequential organ failure assessment (SOFA) score of 2 or larger score points).
Time to sepsis detection (minutes after Intensive Care Unit (ICU) admission)
时间窗: within 7 days after study inclusion
Time to sepsis detection (minutes after ICU admission) based on machine learning
Sepsis related mortality
时间窗: within 7 days after study inclusion
Prediction of sepsis related mortality (with \>80% sensitivity and specificity at least 24h prior to event)
次要结局
未报告次要终点