Prediction of Stroke-associated Pneumonia

Ischemic Stroke Clinical Trial

— PREDICT  

Official title:

Prediction of Stroke-associated Pneumonia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01079728
• Other study ID #: PREDICT
• Status: Completed
• Start date: February 2010
• Est. completion date: April 2013

Study information

• Verified date: December 2021
• Source: Charite University, Berlin, Germany
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 486
• Est. completion date: April 2013
• Est. primary completion date: January 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ischemic Stroke
• Pneumonia
• Stroke

Locations

Country	Name	City	State
Germany	Charite University (Center for Stroke Research Berlin CSB & NeuroCure Clinical Research Center NCRC)	Berlin
Germany	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
Spain	Hospital Vall d'Hebron	Barcelona

Sponsors (3)

Lead Sponsor	Collaborator
Charite University, Berlin, Germany	NeuroCure Clinical Research Center, Charite, Berlin, Siemens Health Care

Countries where clinical trial is conducted

Germany,  Spain, 

References & Publications (6)

Hoffmann S, Harms H, Ulm L, Nabavi DG, Mackert BM, Schmehl I, Jungehulsing GJ, Montaner J, Bustamante A, Hermans M, Hamilton F, Göhler J, Malzahn U, Malsch C, Heuschmann PU, Meisel C, Meisel A; PREDICT Investigators. Stroke-induced immunodepression and dy — View Citation

Hotter B, Hoffmann S, Ulm L, Meisel C, Bustamante A, Montaner J, Katan M, Smith CJ, Meisel A. External Validation of Five Scores to Predict Stroke-Associated Pneumonia and the Role of Selected Blood Biomarkers. Stroke. 2021 Jan;52(1):325-330. doi: 10.1161 — View Citation

Hotter B, Hoffmann S, Ulm L, Meisel C, Fiebach JB, Meisel A. IL-6 Plasma Levels Correlate With Cerebral Perfusion Deficits and Infarct Sizes in Stroke Patients Without Associated Infections. Front Neurol. 2019 Feb 15;10:83. doi: 10.3389/fneur.2019.00083. — View Citation

Hotter B, Hoffmann S, Ulm L, Montaner J, Bustamante A, Meisel C, Meisel A. Inflammatory and stress markers predicting pneumonia, outcome, and etiology in patients with stroke: Biomarkers for predicting pneumonia, functional outcome, and death after stroke — View Citation

Mengel A, Ulm L, Hotter B, Harms H, Piper SK, Grittner U, Montaner J, Meisel C, Meisel A, Hoffmann S. Biomarkers of immune capacity, infection and inflammation are associated with poor outcome and mortality after stroke - the PREDICT study. BMC Neurol. 20 — View Citation

Winek K, Lobentanzer S, Nadorp B, Dubnov S, Dames C, Jagdmann S, Moshitzky G, Hotter B, Meisel C, Greenberg DS, Shifman S, Klein J, Shenhar-Tsarfaty S, Meisel A, Soreq H. Transfer RNA fragments replace microRNA regulators of the cholinergic poststroke imm — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Predictive score for SAP based on clinical parameters assessed within 36h after stroke onset	To establish a predictive score for SAP based on clinical parameters assessed within 36h after stroke onset	SAP within 7 days after onset of symptoms (stroke)
Primary	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	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	SAP within 7 days after onset of symptoms (stroke)
Secondary	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	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	Neurological outcome 3 months after onset of symptoms (stroke)
Secondary	Plasma levels of acetylcholinesterase	To investigate the parasympathetic influence on the immune function after stroke by measuring plasma levels of acetylcholinesterase	within 7 days after onset of symptoms (stroke)
Secondary	Localization and stroke volume analysis	To investigate the influence of the localization and stroke volume on the occurrence of a SAP and on neurological outcome	SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke)
Secondary	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	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	SAP within 7 days after onset of symptoms (stroke)
Secondary	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	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	SAP within 7 days after onset of symptoms (stroke) and neurological outcome after 3 months
Secondary	Transcriptome analyses	To perform transcriptome analyses to identify new biomarkers which may predict the occurence of a SAP or the 3-month neurological outcome	SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke)