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Prediction of Stroke-associated Pneumonia (PREDICT)

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ClinicalTrials.gov Identifier: NCT01079728
Recruitment Status : Completed
First Posted : March 3, 2010
Last Update Posted : January 4, 2022
Sponsor:
Collaborators:
Siemens Health Care
NeuroCure Clinical Research Center, Charite, Berlin
Information provided by (Responsible Party):
Andreas Meisel, Charite University, Berlin, Germany

Study Description
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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
Ischemic Stroke

Study Design
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Study Type : Observational
Actual Enrollment : 486 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Prediction of Stroke-associated Pneumonia
Study Start Date : February 2010
Actual Primary Completion Date : January 2013
Actual Study Completion Date : April 2013

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Group/Cohort
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
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Primary Outcome Measures :
  1. 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) ]
    To establish a predictive score for SAP based on clinical parameters assessed within 36h after stroke onset

  2. 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) ]
    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 :
  1. 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) ]
    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

  2. Plasma levels of acetylcholinesterase [ Time Frame: 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

  3. Localization and stroke volume analysis [ Time Frame: 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

  4. 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) ]
    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

  5. 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 ]
    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

  6. Transcriptome analyses [ Time Frame: 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


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

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01079728


Locations
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Germany
Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
Berlin, Germany, 10117
Unfallkrankenhaus Berlin, Neurologie
Berlin, Germany
Vivantes Auguste Viktoria Klinikum Neurologie
Berlin, Germany
Vivantes Klinikum im Friedrichshain Neurologie
Berlin, Germany
Vivantes Klinikum Spandau Neurologie
Berlin, Germany
Vivantes Neukölln Neurologie
Berlin, Germany
Sankt Josefs Krankenhaus Potsdam Neurologie
Potsdam, Germany
Spain
Hospital Vall d'Hebron
Barcelona, Spain
Sponsors and Collaborators
Charite University, Berlin, Germany
Siemens Health Care
NeuroCure Clinical Research Center, Charite, Berlin
Investigators
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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
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Publications of Results:

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Responsible Party: Andreas Meisel, Professor Dr. med., Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01079728    
Other Study ID Numbers: PREDICT
First Posted: March 3, 2010    Key Record Dates
Last Update Posted: January 4, 2022
Last Verified: December 2021
Keywords provided by Andreas Meisel, Charite University, Berlin, Germany:
ischemic stroke
stroke-associated pneumonia
prediction
immune and infection parameters
Additional relevant MeSH terms:
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Pneumonia
Stroke
Ischemic Stroke
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
 Vascular Diseases
Cardiovascular Diseases
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases