Clinical trial NCT00906542: Predictors of Early Chest Infection in Acute Ischemic Stroke
Official title: Predictors of Early Chest Infection in Acute Ischemic Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Ischemic Stroke
Pneumonia
Keywords: acute stroke
ischemic stroke
pneumonia
chest infection
brain lesion
lesion topology
dysphagia
sympathetic activation
immunosuppression
Lead sponsor: University of Rostock
Sponsor class: OTHER
First posted: 2009-05-21
Enrollment: 530
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Acute ischemic stroke patients admitted to the neurological intensive care unit or stroke unit within 24 hours after stroke onset

Brief 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.


Eligibility criteria: 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

Primary outcomes:
measure: diagnosis of chest infection within 7 days after stroke
timeFrame: days 1-7 after stroke
Secondary outcomes:
Other outcomes:
Locations:
city: Rostock
country: Germany
facility: University of Rostock, Department of Neurology
Study officials:
affiliation: University of Rostock, Germany
name: Uwe Walter, MD
role: STUDY_CHAIR
References:
citation: Prass K, Meisel C, Hoflich 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. doi: 10.1084/jem.20021098. Epub 2003 Aug 25.
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. doi: 10.1136/jnnp.2006.100800.
citation: Chamorro A, Amaro S, Vargas M, Obach V, Cervera A, Gomez-Choco M, Torres F, Planas AM. Catecholamines, infection, and death in acute ischemic stroke. J Neurol Sci. 2007 Jan 15;252(1):29-35. doi: 10.1016/j.jns.2006.10.001. Epub 2006 Nov 28.
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. doi: 10.1007/s00415-007-0520-0. Epub 2007 Mar 14.
citation: Vogelgesang A, Grunwald U, Langner S, Jack R, Broker 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. doi: 10.1161/STROKEAHA.107.493635. Epub 2007 Nov 29.
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.