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RecruitingNCT05891873Updated Oct 23, 2023

Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations

An observational study in Delirium, sponsored by Masaryk University. Recruiting at 1 site in Czechia. Per ClinicalTrials.gov, last updated 2023-10-23.

Sponsored by Masaryk University · Observational

From the registry’s dates

  • Started Sep 2023; still recruiting 3 years 1 month later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
700
Sex
All
01

Study 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.

Read the detailed description

Design

  • Multicentre observational follow-up cohort study with 2 different cohorts and a minimum follow-up period of 6 months.

Recruitment (groups)

  1. Neurointensive/neurocritical group (N-ICU): patients with acute ischaemic or haemorrhagic stroke admitted to the Stroke Unit or ICU of the Department of Neurology, University Hospital Brno (NK-UHB).
  2. Paediatric intensive/critical group (P-ICU): children aged 6-18 years, admitted to the Paediatric ICU - Department of Paediatric Anaesthesiology and Intensive Care (KDAR-UHB) with a stay of at least 24 hours (including postoperative care).

General working hypotheses

  • Current recommendations for the practical management (PADIS) and prevention of delirium lead to a decrease in the incidence of ICU-delirium and post-ICU dementia and may also change the spectrum of significant risk factors.
  • In the Czech Republic, both general knowledge and practical implementation of these recommendations may be low.
  • Currently recommended screening instruments for ICU-delirium are valid and reliable in both adult and paediatric cohorts of (neuro)intensive/critical patients and can replace the expert assessment using DSM-IV or V criteria (The Diagnostic and Statistical Manual of Mental Illnesses).
  • Non-convulsive status epilepticus (NCSE) may mimic ICU-delirium and a routine EEG exam in patients meeting the criteria for ICU delirium may be helpful.
  • Aphasia may complicate the diagnosis of delirium and may prevent the use of the current screening tools for delirium in neurointensive care patients.
  • Sleep disturbances in ICU patients are often associated with the development of ICU delirium and evaluating the time course of these conditions may reveal their possible causal relationship.

Outcomes Primary outcomes

  • Development of ICU delirium Secondary outcomes
  • Length of stay in ICU
  • Case-fatality risk
  • Post-ICU dementia (BDS, Blessed dementia scale)
  • Degree of functional dependency (Barthel index)

Objectives

  • To review the incidence and significant modifiable and non-modifiable predisposing and precipitating risk factors for ICU delirium and post-ICU dementia in general and neuro-intensive/critical care in adult and paediatric populations treated in health care facilities according to current recommendations for prevention of these complications (ABCDEF bundle).
  • To verify optimal methods for diagnostic screening of ICU delirium: CAM-ICU (The confusion assessment method for the ICU), 4AT (Rapid clinical test for delirium detection - 4AT) and ICDSC (Intensive care delirium screening checklist) in adult populations and pCAM-ICU (paediatric confusion assessment method for the ICU), psCAM-ICU (pre-school confusion assessment method for the ICU) and CAPD (Cornell Assessment of Pediatric Delirium) in paediatric populations to screen for delirium.
  • To verify optimal methods for the differential diagnosis of conditions that mimic or complicate the diagnosis of ICU delirium: NCSE, aphasia,
  • To investigate associations between sleep disturbances and ICU-delirium to confirm their role in the pathophysiology of delirium.
02

Conditions studied

  • Delirium

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Keywords

  • delirium
  • delirium screening
  • ICU delirium
03

In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's planned enrollment of 700 is above the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Masaryk University is the lead sponsor of 40 studies on the registry; 21 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Neurointensive/neurocritical group (N-ICU): patients with acute ischaemic or haemorrhagic stroke admitted to the Stroke Unit or ICU of the Department of Neurology, University Hospital Brno (NK-UHB).

Paediatric intensive/critical group (P-ICU): children aged 6-18 years, admitted to the Paediatric ICU - Department of Paediatric Anaesthesiology and Intensive Care (KDAR-UHB) with a stay of at least 24 hours (including postoperative care).

Inclusion criteria

  • Neurointensive/neurocritical group (N-ICU): patients with acute ischaemic or haemorrhagic stroke admitted to the Stroke Unit or ICU of the Department of Neurology, University Hospital Brno (NK-UHB).
  • Paediatric intensive/critical group (P-ICU): children aged 6-18 years, admitted to the Paediatric ICU - Department of Paediatric Anaesthesiology and Intensive Care (KDAR-UHB) with a stay of at least 24 hours (including postoperative care).

Exclusion criteria

Exclusion Criteria:

  • (N-ICU) severe trauma with short life expectancy (days)
  • duration of the ICU stay shorter than 24 hours
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
700 participants (estimated)
Patient registry
No

Groups and cohorts

  • Neurointensive/neurocritical group (N-ICU)

    Diagnostic Test: CAM-ICU · Diagnostic Test: ICDSC · Diagnostic Test: 4AT · Diagnostic Test: MASTcz (The Mississippi Aphasia Screening Test) · Diagnostic Test: EEG

  • Paediatric intensive/critical group (P-ICU)

    Diagnostic Test: p(s)CAM-ICU · Diagnostic Test: CAPD · Diagnostic Test: EEG

Interventions

  • Diagnostic testCAM-ICU

    Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.

  • Diagnostic testICDSC

    Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.

  • Diagnostic test4AT

    Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.

  • Diagnostic testp(s)CAM-ICU

    Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.

  • Diagnostic testCAPD

    Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.

  • Diagnostic testMASTcz (The Mississippi Aphasia Screening Test)

    People with aphasia will be examined by a skilled speech therapist.

  • Diagnostic testEEG

    Patients with positive delirium will undergo EEG examination. 10-min native EEG.

06

What researchers measure

Primary outcomes

  1. Number of participants who develop ICU delirium

    assessed by experienced neuro-intensivist

    Time frame: up to 14 days after admission

Secondary outcomes

  1. Length of stay in ICU

    Time frame: up to 10 weeks

  2. Mortality

    Time frame: 6 months

  3. Number of participants and severity of post-ICU dementia, cognitive impairment(Blessed dementia scale, BDS)

    Time frame: 6 months

  4. Degree of functional dependency (Barthel index)

    the higher score, the worse result meaning cognitive impairment and non-independence

    Time frame: up to 10 weeks and after 6 months

07

Study locations

1 of 1 sites recruiting
  • Brno University Hospital
    Brno, 62500, Czechia
    Recruiting
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 23, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05891873
Lead sponsor
Masaryk University
Collaborators
Brno University Hospital, University Hospital, Motol
Responsible party
Sponsor
First posted
Jun 7, 2023
Start date
Sep 7, 2023
Primary completion
May 2027 (estimated)
Completion
Dec 2027 (estimated)
Last update
Oct 23, 2023

Study contacts

Josef Bednařík, prof. MD, CSc.
Contact
bednarik.josef@fnbrno.cz
532231481
Lucia Bakošová, MD
Contact
bakosova.lucia@fnbrno.cz
532232503

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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