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White Cell Ratios as Markers of Delirium and Outcome in Acute Ischemic Stroke. (DELIAS)

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ClinicalTrials.gov Identifier: NCT03944694
Recruitment Status : Completed
First Posted : May 9, 2019
Last Update Posted : May 10, 2019
Sponsor:
Information provided by (Responsible Party):
Katarzyna Kotfis, Pomeranian Medical University Szczecin

Brief Summary:
The aim of this study was to investigate the role of Neutrophil-to-Lymphocyte Ratio (NLR) and other derived white cell markers as early markers of delirium and outcome after acute ischemic stroke (AIS).

Condition or disease Intervention/treatment
Delirium Ischemic Stroke Diagnostic Test: Delirium assessment.

Detailed Description:
Delirium is an acute brain disorder, potentially reversible, commonly occurring in patients with acute ischemic stroke. The pathomechanism of delirium is related to neuroinflammatory process and oxidative stress. Search for readily available diagnostic marker that will aid clinicians in early identification of delirium is an on-going process. The aim of this study was to investigate the role of Neutrophil-to-Lymphocyte Ratio (NLR) and other derived white cell markers as early markers of delirium and outcome after acute ischemic stroke (AIS).

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Study Type : Observational
Actual Enrollment : 1001 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: White Cell Ratios as Markers of Delirium and Outcome in Acute Ischemic Stroke. DELirium in Acute Ischemic Stroke [DELIAS]
Actual Study Start Date : June 30, 2015
Actual Primary Completion Date : March 31, 2019
Actual Study Completion Date : March 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium

Group/Cohort Intervention/treatment
Delirious
Patients were delirious if CAM-ICU was positive within 24 hours from admission due to acute ischemic stroke.
Diagnostic Test: Delirium assessment.
Full blood count analysis.

Non-delirious
Patients were delirious if CAM-ICU was negative within 24 hours from admission due to acute ischemic stroke.
Diagnostic Test: Delirium assessment.
Full blood count analysis.




Primary Outcome Measures :
  1. Early-onset-delirium. [ Time Frame: 24 hours ]
    Delirium within 24 hours from admission.


Secondary Outcome Measures :
  1. Mortality at 30 days. [ Time Frame: 30 days ]
    Mortality determined at follow-up on day 30 after acute ischemic stroke.

  2. Mortality at 1 year. [ Time Frame: 1 year ]
    Mortality determined at follow-up at 1 year after acute ischemic stroke.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Consecutive adult patients (age >18 years) with acute ischemic stroke, admitted to a neurology department of a busy district general hospital in Poland between 30.06.2015 and 31.03.2018. Patients with AIS were admitted to the neurology department within 48 hours of symptom development.
Criteria

Inclusion Criteria:

  • age >18 years)
  • acute ischemic stroke

Exclusion Criteria:

  • hematology disorders
  • incomplete laboratory testing
  • no data regarding follow-up

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03944694


Sponsors and Collaborators
Pomeranian Medical University Szczecin
Investigators
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Study Chair: Iwona Rotter, MD, PhD Pomeranian Medical University Szczecin
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Responsible Party: Katarzyna Kotfis, Principal Investigator, Pomeranian Medical University Szczecin
ClinicalTrials.gov Identifier: NCT03944694    
Other Study ID Numbers: 0012/84/03/19
First Posted: May 9, 2019    Key Record Dates
Last Update Posted: May 10, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Katarzyna Kotfis, Pomeranian Medical University Szczecin:
delirium
stroke
neutrophil-to-lymphocyte ratio
NLR
mortality
Additional relevant MeSH terms:
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Stroke
Cerebral Infarction
Delirium
Ischemia
Cerebrovascular Disorders
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Vascular Diseases
Cardiovascular Diseases
Pathologic Processes
Brain Infarction
Brain Ischemia
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Neurocognitive Disorders
Mental Disorders