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Prediction of Stroke-associated Pneumonia (PREDICT)

This study has been completed.
Sponsor:
Collaborator:
Siemens Health Care
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01079728
First received: March 2, 2010
Last updated: June 19, 2013
Last verified: June 2013
  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:


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)


Enrollment: 486
Study Start Date: February 2010
Study Completion Date: April 2013
Primary Completion Date: January 2013 (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Locations
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
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: Prof. Dr. Andreas Meisel, Charite University, Berlin, Germany (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)
ClinicalTrials.gov Identifier: NCT01079728     History of Changes
Other Study ID Numbers: PREDICT
Study First Received: March 2, 2010
Last Updated: June 19, 2013
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:
Cerebral Infarction
Stroke
Pneumonia
Brain Diseases
Brain Infarction
Brain Ischemia
Cardiovascular Diseases
Central Nervous System Diseases
Cerebrovascular Disorders
Lung Diseases
Nervous System Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Vascular Diseases

ClinicalTrials.gov processed this record on November 24, 2014