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出境医 / 临床实验 / White Cell Ratios as Markers of Delirium and Outcome in Acute Ischemic Stroke. (DELIAS)
White Cell Ratios as Markers of Delirium and Outcome in Acute Ischemic Stroke. (DELIAS)
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 | 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).
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 30, 2015 |
| Actual Primary Completion Date : | March 31, 2019 |
| Actual Study Completion Date : | March 31, 2019 |
Arms 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.
|
Outcome Measures
Primary Outcome Measures :
- Early-onset-delirium. [ Time Frame: 24 hours ]Delirium within 24 hours from admission.
Secondary Outcome Measures :
- Mortality at 30 days. [ Time Frame: 30 days ]Mortality determined at follow-up on day 30 after acute ischemic stroke.
- 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
Sponsors and Collaborators
Pomeranian Medical University Szczecin
Investigators
| Study Chair: | Iwona Rotter, MD, PhD | Pomeranian Medical University Szczecin |
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Submitted Date | May 8, 2019 | ||||
| First Posted Date | May 9, 2019 | ||||
| Last Update Posted Date | May 10, 2019 | ||||
| Actual Study Start Date | June 30, 2015 | ||||
| Actual Primary Completion Date | March 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures |
Early-onset-delirium. [ Time Frame: 24 hours ] Delirium within 24 hours from admission.
|
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| Original Primary Outcome Measures | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures |
|
||||
| Original Secondary Outcome Measures | Same as current | ||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title | White Cell Ratios as Markers of Delirium and Outcome in Acute Ischemic Stroke. | ||||
| Official Title | White Cell Ratios as Markers of Delirium and Outcome in Acute Ischemic Stroke. DELirium in Acute Ischemic Stroke [DELIAS] | ||||
| 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). | ||||
| 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 | ||||
| Study Design | Observational Model: Cohort Time Perspective: Prospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| 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. | ||||
| Condition |
|
||||
| Intervention | Diagnostic Test: Delirium assessment.
Full blood count analysis.
|
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| Study Groups/Cohorts |
|
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| Publications * | Not Provided | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status | Completed | ||||
| Actual Enrollment |
1001 | ||||
| Original Actual Enrollment | Same as current | ||||
| Actual Study Completion Date | March 31, 2019 | ||||
| Actual Primary Completion Date | March 31, 2019 (Final data collection date for primary outcome measure) | ||||
| Eligibility Criteria |
Inclusion Criteria:
Exclusion Criteria:
|
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| Sex/Gender |
|
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| Ages | 18 Years and older (Adult, Older Adult) | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts | Contact information is only displayed when the study is recruiting subjects | ||||
| Listed Location Countries | Not Provided | ||||
| Removed Location Countries | |||||
| Administrative Information | |||||
| NCT Number | NCT03944694 | ||||
| Other Study ID Numbers | 0012/84/03/19 | ||||
| Has Data Monitoring Committee | No | ||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement |
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| Responsible Party | Katarzyna Kotfis, Pomeranian Medical University Szczecin | ||||
| Study Sponsor | Pomeranian Medical University Szczecin | ||||
| Collaborators | Not Provided | ||||
| Investigators |
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| PRS Account | Pomeranian Medical University Szczecin | ||||
| Verification Date | May 2019 | ||||
