Predictors of Early Chest Infection in Acute Ischemic Stroke

Pneumonia Clinical Trial

— PRECAST  

Official title:

Predictors of Early Chest Infection in Acute Ischemic Stroke

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00906542
• Other study ID #: PRECAST-01
• Status: Completed
• Phase: N/A
• First received: May 20, 2009
• Last updated: February 18, 2010
• Start date: May 2009
• Est. completion date: February 2010

Study information

• Verified date: February 2010
• Source: University of Rostock
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Ethics Commission
• Study type: Observational

Clinical Trial Summary

Pneumonia is a frequent complication of acute stroke and is associated with increased mortality and long-term impairment in the affected subjects. In previous studies, a number of clinical (e.g., dysphagia, severe neurological impairment, mechanical ventilation), radiological (e.g., large infarctions in the territory of middle cerebral artery, insular infarction) and biochemical (e.g., increased serum levels of C-reactive protein, decreased levels of CD4+ T-lymphocytes) findings have been reported as risk factors of stroke-related chest infection. The present study (PRECAST) aims to identify a small set out of these previously described risk factors that can predict stroke-related pneumonia with high sensitivity and specificity.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 530
• Est. completion date: February 2010
• Est. primary completion date: February 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• acute ischemic stroke

• admission to the neurological intensive care unit or stroke unit within 24 hours after stroke onset

• clearly assessed brain lesion location

Exclusion Criteria:

• previous large (non-lacunar) stroke

• chest infection present already on hospital admission

• mechanical ventilation already on day 1 or 2 after hospital admission

• treatment with immunosuppressive drugs

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Ischemic Stroke
• Ischemia
• Pneumonia
• Stroke

Locations

Country	Name	City	State
Germany	University of Rostock, Department of Neurology	Rostock

Sponsors (1)

Lead Sponsor	Collaborator
University of Rostock

Country where clinical trial is conducted

Germany, 

References & Publications (6)

Chamorro A, Amaro S, Vargas M, Obach V, Cervera A, Gómez-Choco M, Torres F, Planas AM. Catecholamines, infection, and death in acute ischemic stroke. J Neurol Sci. 2007 Jan 15;252(1):29-35. Epub 2006 Nov 28. — View Citation

Chamorro A, Amaro S, Vargas M, Obach V, Cervera A, Torres F, Planas AM. Interleukin 10, monocytes and increased risk of early infection in ischaemic stroke. J Neurol Neurosurg Psychiatry. 2006 Nov;77(11):1279-81. — View Citation

Prass K, Meisel C, Höflich C, Braun J, Halle E, Wolf T, Ruscher K, Victorov IV, Priller J, Dirnagl U, Volk HD, Meisel A. Stroke-induced immunodeficiency promotes spontaneous bacterial infections and is mediated by sympathetic activation reversal by poststroke T helper cell type 1-like immunostimulation. J Exp Med. 2003 Sep 1;198(5):725-36. Epub 2003 Aug 25. — View Citation

Steinhagen V, Grossmann A, Benecke R, Walter U. Swallowing disturbance pattern relates to brain lesion location in acute stroke patients. Stroke. 2009 May;40(5):1903-6. doi: 10.1161/STROKEAHA.108.535468. Epub 2009 Mar 12. — View Citation

Vogelgesang A, Grunwald U, Langner S, Jack R, Bröker BM, Kessler C, Dressel A. Analysis of lymphocyte subsets in patients with stroke and their influence on infection after stroke. Stroke. 2008 Jan;39(1):237-41. Epub 2007 Nov 29. — View Citation

Walter U, Knoblich R, Steinhagen V, Donat M, Benecke R, Kloth A. Predictors of pneumonia in acute stroke patients admitted to a neurological intensive care unit. J Neurol. 2007 Oct;254(10):1323-9. Epub 2007 Mar 14. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	diagnosis of chest infection within 7 days after stroke		days 1-7 after stroke	No