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Prediction of Stroke-associated Pneumonia

Prediction of Stroke-associated Pneumonia

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01079728
Acronym
PREDICT
Enrollment
486
Registered
2010-03-03
Start date
2010-02-28
Completion date
2013-04-30
Last updated
2022-01-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ischemic Stroke

Keywords

ischemic stroke, stroke-associated pneumonia, prediction, immune and infection parameters

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.

Interventions

None listed

Sponsors

Siemens Health Care
CollaboratorUNKNOWN
NeuroCure Clinical Research Center, Charite, Berlin
CollaboratorOTHER
Charite University, Berlin, Germany
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Predictive score for SAP based on clinical parameters assessed within 36h after stroke onsetSAP 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 onsetSAP 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

MeasureTime frameDescription
Localization and stroke volume analysisSAP 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 SAPSAP 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
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 outcomeNeurological 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
Transcriptome analysesSAP 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
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 monthsSAP within 7 days after onset of symptoms (stroke) and neurological outcome after 3 monthsTo 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
Plasma levels of acetylcholinesterasewithin 7 days after onset of symptoms (stroke)To investigate the parasympathetic influence on the immune function after stroke by measuring plasma levels of acetylcholinesterase

Countries

Germany, Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 4, 2026