Prediction of Stroke-associated Pneumonia

Study Overview
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Brief Summary
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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.

Official Title
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Prediction of Stroke-associated Pneumonia

Conditions
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Ischemic Stroke

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: ischemic stroke in the anterior (ACA, MCA) and posterior cerebral circulation (PCA, BA) of any severity stroke onset within the last 36h age ≥ 18 consent by the patient or the legal representative Exclusion Criteria: intracranial hemorrhage signs of infection at admission (clinical / paraclinical) pre-existing dysphagia mechanical ventilation at admission participation in an interventional trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ischemic stroke patients<br>patients with an ischemic stroke in the anterior (ACA, MCA) and posterior flow area (PCA, BA) of any severity in the last 36h | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predictive score for SAP based on clinical parameters assessed within 36h after stroke onset | To establish a predictive score for SAP based on clinical parameters assessed within 36h after stroke onset | SAP within 7 days after onset of symptoms (stroke) | 
| 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 | 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 | SAP within 7 days after onset of symptoms (stroke) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | To evaluate of the 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) | 
| Plasma levels of acetylcholinesterase | To investigate the parasympathetic influence on the immune function after stroke by measuring plasma levels of acetylcholinesterase | within 7 days after onset of symptoms (stroke) | 
| Localization and stroke volume analysis | To investigate the influence of the localization and stroke volume on the occurrence of a SAP and on neurological outcome | SAP within 7 days and neurological outcome after 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 | To evaluate of the 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 | To investigate the influence of insular cortex involvement and infarct volume on the occurrence of a SAP within 7 days after stroke onset 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 | To perform transcriptome analyses to identify new biomarkers which may predict the occurence of a SAP or the 3-month neurological outcome | SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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ischemic stroke, stroke-associated pneumonia, prediction, immune and infection parameters