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For a long time, delirium was considered a merely temporary dysfunction of the brain. Today, it is established that it is a brain disease associated with network dysfunction, neuroinflammation and impaired transmitter homeostasis in a multicausal model. Following an episode of delirium, many patients do not return to their prior level of cognitive and functional performance. In particular, failed or delayed diagnosis with consecutive inadequate therapy contribute to the development of long-term cognitive decline that may ultimately lead to long-term care. Stroke patients are a particularly common delirium-affected population (10-46% depending on severity). Despite the frequency and clinical relevance of delirium in stroke patients, diagnostic characteristics of common screening methods are unknown. Similarly, the clinical phenotype and risk factors of patients who develop delirium have not been adequately described.
This study primarily aims to evaluate the diagnostic properties of established screening tools for delirium in a prospective cohort of well-characterised patients following ischemic cerebral events (either transient or manifest stroke). Secondary outcome criteria include predictors of post-stroke delirium (PSD) such as stroke location and size, pre-stroke cognitive functioning, ability to participate in daily routine activities and medical conditions.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| PSD | Patients fulfilling DSM-5 criteria of PSD within 7 days of admission. |
| |
| No PSD | Patients NOT fulfilling DSM-5 criteria of PSD within 7 days of admission. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Stroke screening tools | Diagnostic Test | Patients are evaluated for the presence of PSD using DSM-5 criteria ("gold standard"). Established delirium detection tools are evaluated for their diagnostic accuracy compared to the gold standard. |
| Measure | Description | Time Frame |
|---|---|---|
| diagnostic accuracy of established delirium detection tools as compared to Diagnostic and Statistical Manual - 5th Version (DSM-5) criteria | Binary outcomes of delirium screening tests will be compared, i.e. if they characterize an individual patient as delirious at any of two time points during the 7 day observation period. Instruments include: Nursing Delirium Screening Scale (Nu-DESC), Confusion Assessment Method (CAM), rapid assessment test for delirium (4-AT). Binary outcomes ("yes" or "no" according to each of the scales) are then aggregated in one test that compares the observed frequency of delirious patients (according the above mentioned tests) with the actual number of delirious patients as assessed by the DSM-5 standard. | two times daily for 7 days |
| Measure | Description | Time Frame |
|---|---|---|
| PSD prevalence | DSM-5 criteria and chart review are used to assess the occurence of PSD among included patients over the complete study period | three times daily for 7 days |
| pre-stroke modified Rankin Scale |
| Measure | Description | Time Frame |
|---|---|---|
| demographic data | exploratory outcome required to adjust for confounding variates such as age, socioeconomic status and education | once on admission |
| complications during stroke unit treatment | any complication that arises during the study period (e.g. pneumonia, dysphagia) |
Inclusion Criteria:
Exclusion Criteria:
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Any patient admitted to the emergency department for a suspected ischemic cerebrovascular event is eligible to participate. A neurologist must then confirm the diagnosis and necessity for stroke unit monitoring.
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| Name | Affiliation | Role |
|---|---|---|
| Robert Fleischmann, MD | Department of Neurology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Neurology | Greifswald | Mecklenburg-Vorpommern | 17475 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33380165 | Derived | Fleischmann R, Warwas S, Andrasch T, Kunz R, Witt C, Mengel A, von Sarnowski B. Course and Recognition of Poststroke Delirium: A Prospective Noninferiority Trial of Delirium Screening Tools. Stroke. 2021 Jan;52(2):471-478. doi: 10.1161/STROKEAHA.120.031019. Epub 2020 Dec 31. |
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| ID | Term |
|---|---|
| D003693 | Delirium |
| D000083242 | Ischemic Stroke |
| D002546 | Ischemic Attack, Transient |
| D020521 | Stroke |
| ID | Term |
|---|---|
| D003221 | Confusion |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
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functional status before stroke
| once on admission |
| pre-stroke Barthel Index | ability to take care of personal daily routine before stroke | once on admission |
| pre-stroke Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE) | cognitive impairment before stroke | once on admission |
| pre-stroke Groningen Frailty Index (GFI) | presence of a frailty syndrome before stroke | once on admission |
| National Institutes of Health Stroke Scale (NIHSS) | estimate of clinical stroke severity | three times daily for three days starting on the day of admission |
| Critical Care Pain Observation Tool (CPOT) | pain during stroke unit treatment | once daily for three days starting on the day of admission |
| Stroke location - clinical (classification of the OxfordshireCommunity Stroke Project (OCSP)) | clinical characterisation based on phenotype as either total anterior, partial anterior, partial posterior or lacunar stroke | once on admission |
| Stroke location - imaging (based on an atlas of anatomical regions of the human brain (aal MNI V4)) | in patients with imaging of the definite stroke location, differences of mean locations between groups will be calculated | once on admission |
| continuously during the study period and up to 7 days |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D002561 | Cerebrovascular Disorders |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D002545 | Brain Ischemia |