DeliriumDELIASNCT03944694
White Cell Ratios as Markers of Delirium and Outcome in Acute Ischemic Stroke.
An observational study of Delirium and Ischemic Stroke, run by Pomeranian Medical University Szczecin.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium, Ischemic Stroke
- What is being tested?
- Delirium assessment.
- How many people
- 1,001 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2015to 31 Mar 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- age >18 years)
- acute ischemic stroke
Who cannot join
- hematology disorders
- incomplete laboratory testing
- no data regarding follow-up
About this study
Official title: 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).
Read the 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).
- Conditions
- Delirium, Ischemic Stroke
- Being tested
- Delirium assessment.
- Keywords
- delirium, stroke, neutrophil-to-lymphocyte ratio, NLR, mortality
- Medical subject headings
- Delirium, Ischemic Stroke, Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Delirium assessment.Diagnostic test
Full blood count analysis.
| Study group | Role | What they receive |
|---|---|---|
| Delirious | Patients were delirious if CAM-ICU was positive within 24 hours from admission due to acute ischemic stroke. Receives: Diagnostic Test: Delirium assessment. | |
| Non-delirious | Patients were delirious if CAM-ICU was negative within 24 hours from admission due to acute ischemic stroke. Receives: Diagnostic Test: Delirium assessment. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Early-onset-delirium.
Delirium within 24 hours from admission.
Measured: 24 hours
Secondary outcomes (2)
Mortality at 30 days.
Mortality determined at follow-up on day 30 after acute ischemic stroke.
Measured: 30 days
Mortality at 1 year.
Mortality determined at follow-up at 1 year after acute ischemic stroke.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start30 Jun 2015
- Primary completion31 Mar 2019
- Study completion31 Mar 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,001 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pomeranian Medical University Szczecin
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katarzyna Kotfis, Pomeranian Medical University Szczecin
- Investigators
- Iwona Rotter, MD, PhD, Study chair, Pomeranian Medical University Szczecin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03944694
- Sponsor's protocol ID
- 0012/84/03/19
- Acronym
- DELIAS
- Status last verified
- May 2019
- First submitted
- 8 May 2019
- Last updated
- 10 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- White Cell Ratios as Markers of Delirium and Outcome in Acute Ischemic Stroke. DELirium in Acute Ischemic Stroke [DELIAS]
- ClinicalTrials.gov ID
- NCT03944694
- Acronym / sponsor ID
- DELIAS / 0012/84/03/19
- Conditions
- Delirium, Ischemic Stroke
- Keywords
- delirium, stroke, neutrophil-to-lymphocyte ratio, NLR, mortality
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,001 participants (actual)
- Lead sponsor
- Pomeranian Medical University SzczecinUniversity, hospital or other
- Study start
- 30 Jun 2015 (actual)
- Primary completion
- 31 Mar 2019 (actual)
- Study completion
- 31 Mar 2019 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Delirious | – | Diagnostic Test: Delirium assessment.Patients were delirious if CAM-ICU was positive within 24 hours from admission due to acute ischemic stroke. |
| Non-delirious | – | Diagnostic Test: Delirium assessment.Patients were delirious if CAM-ICU was negative within 24 hours from admission due to acute ischemic stroke. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (2 listed)
- age >18 years)
- acute ischemic stroke
Key exclusion criteria (3 listed)
- hematology disorders
- incomplete laboratory testing
- no data regarding follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Delirium assessment.Full blood count analysis. | Diagnostic test | Delirious, Non-delirious |
Primary outcome
Early-onset-delirium.
Time frame: 24 hours
Delirium within 24 hours from admission.
2 secondary outcomes
Mortality at 30 days.
Time frame: 30 days
Mortality at 1 year.
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 May 2019.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Iwona Rotter, MD, PhD study chair
Pomeranian Medical University Szczecin
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium and Ischemic Stroke, run by Pomeranian Medical University Szczecin.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 May 2019. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Early-onset-delirium. (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 May 2019.