Prediction of Stroke-associated Pneumonia

Completed

• Conditions: Ischemic Stroke

• Registration Number: NCT01079728
• Lead Sponsor: Charite University, Berlin, Germany

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Study First Submitted: 2010-03-02
• Study First Submitted QC: 2010-03-02
• Study First Posted: 2010-03-03
• Primary Completion: 2013-01
• Study Completion: 2013-04
• Status Verified: 2021-12
• Last Update Submitted: 2021-12-15
• Last Update Posted: 2022-01-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 486

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predictive score for SAP based on clinical parameters assessed within 36h after stroke onset	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	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

Secondary Outcome Measures

Name	Time	Method
Localization and stroke volume analysis	SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke)	To investigate the influence of the localization and stroke volume on the occurrence of a SAP and on neurological outcome
Plasma levels of acetylcholinesterase	within 7 days after onset of symptoms (stroke)	To investigate the parasympathetic influence on the immune function after stroke by measuring plasma levels of acetylcholinesterase
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)	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
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)	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
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	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
Transcriptome analyses	SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke)	To perform transcriptome analyses to identify new biomarkers which may predict the occurence of a SAP or the 3-month neurological outcome

Trial Locations

Locations (8)

Vivantes Klinikum im Friedrichshain Neurologie; 🇩🇪 Berlin, Germany

Vivantes Klinikum Spandau Neurologie; 🇩🇪 Berlin, Germany

Sankt Josefs Krankenhaus Potsdam Neurologie; 🇩🇪 Potsdam, Germany

Vivantes Neukölln Neurologie; 🇩🇪 Berlin, Germany

Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC); 🇩🇪 Berlin, Germany

Hospital Vall d'Hebron; 🇪🇸 Barcelona, Spain

Unfallkrankenhaus Berlin, Neurologie; 🇩🇪 Berlin, Germany

Vivantes Auguste Viktoria Klinikum Neurologie; 🇩🇪 Berlin, Germany