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

May 8, 2019 updated by: Katarzyna Kotfis, Pomeranian Medical University Szczecin

White Cell Ratios as Markers of Delirium and Outcome in Acute Ischemic Stroke. DELirium in Acute Ischemic Stroke [DELIAS]

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 Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1001

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

Inclusion Criteria:

  • age >18 years)
  • acute ischemic stroke

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Early-onset-delirium.
Time Frame: 24 hours
Delirium within 24 hours from admission.
24 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Mortality at 30 days.
Time Frame: 30 days
Mortality determined at follow-up on day 30 after acute ischemic stroke.
30 days
Mortality at 1 year.
Time Frame: 1 year
Mortality determined at follow-up at 1 year after acute ischemic stroke.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pomeranian Medical University Szczecin

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 30, 2015

Primary Completion (Actual)

March 31, 2019

Study Completion (Actual)

March 31, 2019

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 8, 2019

First Posted (Actual)

May 9, 2019

Study Record Updates

Last Update Posted (Actual)

May 10, 2019

Last Update Submitted That Met QC Criteria

May 8, 2019

Last Verified

May 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0012/84/03/19

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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