Prediction of Stroke-associated Pneumonia

NCT01079728 | Completed

• 1 other identifier: PREDICT
• Study Type: observational
• Target: 486
• Locations: 2 countries
• Sites: 8

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.

Conditions

Ischemic Stroke

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (6)

• 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)

• Plasma levels of acetylcholinesterase

  within 7 days after onset of symptoms (stroke)

• Localization and stroke volume analysis

  SAP within 7 days and neurological outcome after 3 months after onset of symptoms (stroke)

• 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)

• 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

  SAP within 7 days after onset of symptoms (stroke) and neurological outcome after 3 months

Study Arms (1)

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 Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• intracranial hemorrhage
• signs of infection at admission (clinical / paraclinical)
• pre-existing dysphagia
• mechanical ventilation at admission
• participation in an interventional trial

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Siemens Health Care: collaborator
• NeuroCure Clinical Research Center, Charite, Berlin: collaborator

Study Sites (8)

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

Berlin, 10117, Germany

Location

Unfallkrankenhaus Berlin, Neurologie

Berlin, Germany

Location

Vivantes Auguste Viktoria Klinikum Neurologie

Berlin, Germany

Location

Vivantes Klinikum im Friedrichshain Neurologie

Berlin, Germany

Location

Vivantes Klinikum Spandau Neurologie

Berlin, Germany

Location

Vivantes Neukölln Neurologie

Berlin, Germany

Location

Sankt Josefs Krankenhaus Potsdam Neurologie

Potsdam, Germany

Location

Hospital Vall d'Hebron

Barcelona, Spain

Location

Related Publications (6)

• Hoffmann S, Harms H, Ulm L, Nabavi DG, Mackert BM, Schmehl I, Jungehulsing GJ, Montaner J, Bustamante A, Hermans M, Hamilton F, Gohler J, Malzahn U, Malsch C, Heuschmann PU, Meisel C, Meisel A; PREDICT Investigators. Stroke-induced immunodepression and dysphagia independently predict stroke-associated pneumonia - The PREDICT study. J Cereb Blood Flow Metab. 2017 Dec;37(12):3671-3682. doi: 10.1177/0271678X16671964. Epub 2016 Oct 14.

  PMID: 27733675 RESULT

• 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/STROKEAHA.120.031884. Epub 2020 Dec 7.

  PMID: 33280547 RESULT

• 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. eCollection 2019.

  PMID: 30828313 RESULT

• 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. Neurol Neuroimmunol Neuroinflamm. 2020 Feb 25;7(3):e692. doi: 10.1212/NXI.0000000000000692. Print 2020 May.

  PMID: 32098866 RESULT

• 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. 2019 Jul 3;19(1):148. doi: 10.1186/s12883-019-1375-6.

  PMID: 31269910 RESULT

• 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 immune blockade. Proc Natl Acad Sci U S A. 2020 Dec 22;117(51):32606-32616. doi: 10.1073/pnas.2013542117. Epub 2020 Dec 7.

  PMID: 33288717 RESULT

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood sample (serum, plasma)

MeSH Terms

Conditions

Ischemic Stroke

Condition Hierarchy (Ancestors)

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

Study Officials

• 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)

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Dr. med.

Study Record Dates

• First Submitted: March 2, 2010
• First Posted: March 3, 2010
• Study Start: February 1, 2010
• Primary Completion: January 1, 2013
• Study Completion: April 1, 2013
• Last Updated: January 4, 2022

Record last verified: 2021-12

Locations

DE (7); ES (1)