Prediction of Stroke-associated Pneumonia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 486
- 试验地点
- 8
- 主要终点
- Predictive score for SAP based on clinical parameters assessed within 36h after stroke onset
研究概览
简要总结
Stroke-associated pneumonia (SAP) constitutes a clinically relevant complication of stroke, because it increases the mortality and has a negative impact on the neurological prognosis of the patient.
An early identification of patients at risk for SAP allowing an early initiation of antiinfective therapy may improve the prognosis. To date, no reliable prediction models or clinical scores for stroke-associated pneumonia exist. Recently, it was shown that parameters indicating an impaired immune function are associated with the subsequent occurrence of SAP and could therefore be used as predictors for SAP.
This study will develop and prospectively validate a prognostic score to predict SAP based on clinical parameters. Furthermore, the study examines the prognostic properties of selected immune and infectious parameters for the prediction and diagnosis of SAP. The study will further address the question whether these infectious and immune parameters predict the 3-month-outcome. In a subgroup of patients, MRI parameters on stroke size and localization will be assessed to investigate whether these parameters might allow prediction of SAP or the 3-month-outcome.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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
- •ischemic stroke in the anterior (ACA, MCA) and posterior cerebral circulation (PCA, BA) of any severity
- •stroke onset within the last 36h
- •consent by the patient or the legal representative
排除标准
- •intracranial hemorrhage
- •signs of infection at admission (clinical / paraclinical)
- •pre-existing dysphagia
- •mechanical ventilation at admission
- •participation in an interventional trial
结局指标
主要结局
Predictive score for SAP based on clinical parameters assessed within 36h after stroke onset
时间窗: SAP within 7 days after onset of symptoms (stroke)
To establish a predictive score for SAP based on clinical parameters assessed within 36h after stroke onset
Predictive properties of immune parameters (IL6, IL10, mHLA-DR) or infection parameters (PCT) for the occurrence of a SAP within 7 days after stroke onset
时间窗: SAP within 7 days after onset of symptoms (stroke)
To evaluate of the predictive properties of immune parameters (IL6, IL10, mHLA-DR) or infection parameters (PCT) for the occurrence of a SAP within 7 days after stroke onset
次要结局
- Localization and stroke volume analysis(SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke))
- Plasma levels of acetylcholinesterase(within 7 days after onset of symptoms (stroke))
- Predictive properties of immune parameters (IL6, IL8, IL10, mHLA-DR, MBL, monocytic cytokine secretion after ex vivo stimulation, C5a) and infection parameters (PCT, LBP) for the neurological outcome(Neurological outcome 3 months after onset of symptoms (stroke))
- Predictive properties of immune parameters (IL6, IL8, IL10, mHLA-DR, MBL, monocytic cytokine secretion after ex vivo stimulation, C5a) and infection parameters (PCT, LBP) for the occurence of a SAP(SAP within 7 days after onset of symptoms (stroke))
- Influence of insular cortex involvement and infarct volume on the occurrence of a SAP within 7 days and and on the neurological outcome after 3 months(SAP within 7 days after onset of symptoms (stroke) and neurological outcome after 3 months)
- Transcriptome analyses(SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke))
研究者
Andreas Meisel
Professor Dr. med.
Charite University, Berlin, Germany