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

ConditionDelirium
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorMasaryk University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

(N-ICU) severe trauma with short life expectancy (days)

duration of the ICU stay shorter than 24 hours

Trial 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).

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • CAM-ICU

    Diagnostic test

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

  • ICDSC

    Diagnostic test

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

  • 4AT

    Diagnostic test

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

  • p(s)CAM-ICU

    Diagnostic test

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

  • CAPD

    Diagnostic test

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

  • MASTcz (The Mississippi Aphasia Screening Test)

    Diagnostic test

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

  • EEG

    Diagnostic test

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

Treatment groups

700 Participants
are divided into 2 treatment groups
Group A: Neurointensive/neurocritical group (N-ICU)5 interventions
Group B: Paediatric intensive/critical group (P-ICU)3 interventions

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Masaryk University

Lead sponsor

Brno University Hospital

Collaborator

University Hospital, Motol

Collaborator

Source ClinicalTrials.gov
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