Prediction of Stroke-associated Pneumonia - Full Text View

Sponsor:	Charite University, Berlin, Germany
Information provided by:	Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:	NCT01079728

Purpose

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
Ischemic Stroke

Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Prediction of Stroke-associated Pneumonia

Resource links provided by NLM:

MedlinePlus related topics: Pneumonia

U.S. FDA Resources

Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:

Predictive score for SAP based on clinical parameters assessed within 36h after stroke onset [ Time Frame: SAP within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
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 [ Time Frame: SAP within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
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 [ Time Frame: Neurological outcome 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
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 [ Time Frame: within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
To investigate the parasympathetic influence on the immune function after stroke by measuring plasma levels of acetylcholinesterase
Localization and stroke volume analysis [ Time Frame: SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
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 [ Time Frame: SAP within 7 days after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
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 [ Time Frame: SAP within 7 days after onset of symptoms (stroke) and neurological outcome after 3 months ] [ Designated as safety issue: No ]
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 [ Time Frame: SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke) ] [ Designated as safety issue: No ]
To perform transcriptome analyses to identify new biomarkers which may predict the occurence of a SAP or the 3-month neurological outcome

Biospecimen Retention: Samples Without DNA

Blood sample (serum, plasma)

Estimated Enrollment:	486
Study Start Date:	February 2010
Estimated Study Completion Date:	August 2011
Estimated Primary Completion Date:	August 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts
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

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Probability Sample

Study Population

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

Criteria

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

Please refer to this study by its ClinicalTrials.gov identifier: NCT01079728

Contacts

Contact: Andreas Meisel, MD	+49 30 450 ext 560026	andreas.meisel@charite.de
Contact: Hendrik Harms, MD	+49 30 450 ext 539724	hendrik.harms@charite.de

Locations

Germany
Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)	Recruiting
Berlin, Germany, 10117
Contact: Hendrik Harms, MD +49 30 450 ext 539724 hendrik.harms@charite.de
Sub-Investigator: Hendrik Harms, MD

Sponsors and Collaborators

Charite University, Berlin, Germany

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)

More Information

No publications provided

Responsible Party:	Charite University, Berlin, Germany (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC) ( Prof. Dr. Andreas Meisel )
ClinicalTrials.gov Identifier:	NCT01079728 History of Changes
Other Study ID Numbers:	PREDICT
Study First Received:	March 2, 2010
Last Updated:	March 8, 2010
Health Authority:	Germany: Ethics Commission of the Charité University Berlin

Keywords provided by Charite University, Berlin, Germany:

ischemic stroke
stroke-associated pneumonia
prediction
immune and infection parameters

Additional relevant MeSH terms:

Ischemia
Pneumonia
Stroke
Cerebral Infarction
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections

Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Brain Infarction
Brain Ischemia

ClinicalTrials.gov processed this record on September 01, 2010