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NCT Number: NCT01079728

Prediction of Stroke-associated Pneumonia

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.

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Key information

Conditions

Ischemic Stroke Brain Diseases Cardiovascular Diseases Central Nervous System Diseases Cerebrovascular Disorders Nervous System Diseases Stroke Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

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

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Charite University, Berlin, Germany

Other

Collaborators

  • NeuroCure Clinical Research Center, Charite, Berlin
  • Siemens Health Care

Registry information

Acronym: PREDICT

Important dates

Study start
2010
Primary completion
2013
Study completion
2013
First posted
Mar 3, 2010
Registry last updated
Jan 4, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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