Brief Summary

Intensive and critical care in the intensive care unit (ICU) is often associated with ICU delirium and post-ICU dementia, regardless of the nature of the primary disease or insult. Optimal practical management of ICU delirium including its screening, prevention, and treatment, is an integral part of the current recommendations for optimal ICU care, but there are large gaps in the knowledge about the optimal and most effective prevention and treatment of this complication. Information on the actual implementation of these recommendations in the Czech Republic is lacking. The diagnosis of delirium is particularly challenging in neurointensive care patients (due to overlap with symptoms of primary brain lesions) and in a paediatric population. A complementary multicentre observational 4-year follow-up study, performed in an adult neurointensive/critical care stroke cohort and in a paediatric intensive/critical care cohort in centres following currently recommended preventive measures (Delusion-deep-cz) will investigate the incidence of ICU delirium and post-ICU dementia and their modifiable and non-modifiable predisposing and precipitating risk factors. Objectives are to determine the optimal methods for diagnostic screening of these complications and for the differential diagnosis of conditions mimicking delirium (non-convulsive epileptic state) or symptoms hindering its diagnosis (aphasia), and to study the association between sleep disturbances and ICU delirium to verify the role of sleep in the pathophysiology of delirium.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

700

participants targeted

Target at P75+ for all trials

Timeline

20mo left

Started Sep 2023

Longer than P75 for all trials

Geographic Reach

1 country

1 active site

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

4.2 years study duration

Study Progress63%

Sep 2023Dec 2027

First Submitted

Initial submission to the registry

May 17, 2023

Completed

21 days until next milestone

First Posted

Study publicly available on registry

June 7, 2023

Completed

3 months until next milestone

Study Start

First participant enrolled

September 7, 2023

Completed

3.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2027

Expected

7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

October 23, 2023

Status Verified

October 1, 2023

Enrollment Period

3.6 years

First QC Date

May 17, 2023

Last Update Submit

October 18, 2023

Conditions

Delirium

Keywords

deliriumdelirium screeningICU delirium

Outcome Measures

Primary Outcomes (1)

Number of participants who develop ICU delirium
assessed by experienced neuro-intensivist
up to 14 days after admission

Secondary Outcomes (4)

Length of stay in ICU
up to 10 weeks
Mortality
6 months
Number of participants and severity of post-ICU dementia, cognitive impairment(Blessed dementia scale, BDS)
6 months
Degree of functional dependency (Barthel index)
up to 10 weeks and after 6 months

Study Arms (2)

Neurointensive/neurocritical group (N-ICU)

Diagnostic Test: CAM-ICUDiagnostic Test: ICDSCDiagnostic Test: 4ATDiagnostic Test: MASTcz (The Mississippi Aphasia Screening Test)Diagnostic Test: EEG