PREDICT: Prediction of Stroke-associated Pneumonia

Sponsor

Charite University, Berlin, Germany (Other)

Overall Status

Completed

CT.gov ID

NCT01079728

Collaborator

Siemens Health Care (Other), NeuroCure Clinical Research Center, Charite, Berlin (Other)

486

Enrollment

Locations

37.9

Duration (Months)

60.8

Patients Per Site

1.6

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Ischemic Stroke

Study Design

Study Type:

Observational

Actual Enrollment :

486 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Prediction of Stroke-associated Pneumonia

Study Start Date :

Feb 1, 2010

Actual Primary Completion Date :

Jan 1, 2013

Actual Study Completion Date :

Apr 1, 2013

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

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

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
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
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
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)	Berlin	Germany	10117
2	Unfallkrankenhaus Berlin, Neurologie	Berlin	Germany
3	Vivantes Auguste Viktoria Klinikum Neurologie	Berlin	Germany
4	Vivantes Klinikum im Friedrichshain Neurologie	Berlin	Germany
5	Vivantes Klinikum Spandau Neurologie	Berlin	Germany
6	Vivantes Neukölln Neurologie	Berlin	Germany
7	Sankt Josefs Krankenhaus Potsdam Neurologie	Potsdam	Germany
8	Hospital Vall d'Hebron	Barcelona	Spain

Sponsors and Collaborators

Charite University, Berlin, Germany
Siemens Health Care
NeuroCure Clinical Research Center, Charite, Berlin

Investigators

Principal Investigator: Andreas Meisel, MD, Charite University Berlin (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Principal Investigator: Peter Heuschmann, MD, Charité University Berlin (Center for Stroke Research Berlin CSB)