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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/24/2021.

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

Clinicaltrials.gov identifier NCT03944694

Recruitment Status Completed

First Posted May 9, 2019

Last update posted May 10, 2019

Study Description

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:Delirium
    Ischemic Stroke
  • Intervention/Treatment: Diagnostic Test: Delirium assessment.
  • Phase: N/A
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).

Study Design
  • 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 2015
  • Actual Primary Completion Date: March 2019
  • Actual Study Completion Date: March 2019
Groups and Cohorts
Groups/Cohorts 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.
Outcome Measures
  • 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.
Eligibility Criteria
  • 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

Contacts and Locations
Contacts
Locations
Sponsors and Collaborators

Pomeranian Medical University Szczecin

Investigators

Study Chair: Iwona Rotter, MD, PhD Pomeranian Medical University Szczecin

More Information
  • Responsible Party: Pomeranian Medical University Szczecin
  • ClinicalTrials.gov Identifier: NCT03944694 History of Changes
  • 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
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Pomeranian Medical University Szczecin: delirium
    stroke
    neutrophil-to-lymphocyte ratio
    mortality
    NLR
  • Additional relevant MeSH terms: Stroke
    Cerebral Infarction
    Delirium
    Ischemia