Prediction of Stroke-associated Pneumonia "PREDICT"

Completed

Phase N/A Results N/A

Trial Description

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.

Conditions

Trial Design

  • Observation: Case-Only
  • Perspective: Prospective
  • Sampling: Probability Sample

Trial Population

ischemic stroke in the anterior (ACA, MCA) and posterior cerebral circulation (PCA, BA) of any severity in the last 36h

Outcomes

Type Measure Time Frame Safety Issue
Primary Predictive score for SAP based on clinical parameters assessed within 36h after stroke onset SAP within 7 days after onset of symptoms (stroke) No
Primary 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) No
Secondary 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) No
Secondary Plasma levels of acetylcholinesterase within 7 days after onset of symptoms (stroke) No
Secondary Localization and stroke volume analysis SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke) No
Secondary 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) No
Secondary 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 No
Secondary Transcriptome analyses SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke) No

Biospecimen Retention:Samples Without DNA - Blood sample (serum, plasma)

Sponsors