Clinical trial NCT03930719: Post-stroke Delirium Screening
Official title: Evaluation of Delirium Screening Tools for the Detection of Post-stroke Delirium
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Ischemic Stroke
Transient Ischemic Attack
Keywords: stroke
delirium
screening tool
Lead sponsor: University Medicine Greifswald
Sponsor class: OTHER
First posted: 2019-04-29
Enrollment: 141
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* stroke unit admission for a high-risk transient ischemic attack (ABCD2 score \>= 6) or stroke within the last 24 hours

Exclusion Criteria:

* hemorrhagic stroke

Primary outcomes:
measure: diagnostic accuracy of established delirium detection tools as compared to Diagnostic and Statistical Manual - 5th Version (DSM-5) criteria
timeFrame: two times daily for 7 days
Secondary outcomes:
measure: PSD prevalence
timeFrame: three times daily for 7 days
measure: pre-stroke modified Rankin Scale
timeFrame: once on admission
measure: pre-stroke Barthel Index
timeFrame: once on admission
measure: pre-stroke Informant Questionnaire on Cognitive Decline in the Elderly (IQCODE)
timeFrame: once on admission
measure: pre-stroke Groningen Frailty Index (GFI)
timeFrame: once on admission
measure: National Institutes of Health Stroke Scale (NIHSS)
timeFrame: three times daily for three days starting on the day of admission
measure: Critical Care Pain Observation Tool (CPOT)
timeFrame: once daily for three days starting on the day of admission
measure: Stroke location - clinical (classification of the OxfordshireCommunity Stroke Project (OCSP))
timeFrame: once on admission
measure: Stroke location - imaging (based on an atlas of anatomical regions of the human brain (aal MNI V4))
timeFrame: once on admission
Other outcomes:
measure: demographic data
timeFrame: once on admission
measure: complications during stroke unit treatment
timeFrame: continuously during the study period and up to 7 days
Locations:
city: Greifswald
country: Germany
facility: Department of Neurology
state: Mecklenburg-Vorpommern
Study officials:
affiliation: Department of Neurology
name: Robert Fleischmann, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.