DeliriumNCT05891873
Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
An observational study of Delirium, run by Masaryk University at 1 site in Czechia.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Delirium
- What is being tested?
- CAM-ICU, ICDSC and 4AT
- How many people
- 700 participants
- Where
- 1 siteCzechia
- Study dates
- 7 Sep 2023to Dec 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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).
Who may be able to join
- 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).
Who cannot join
- (N-ICU) severe trauma with short life expectancy (days)
- duration of the ICU stay shorter than 24 hours
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Czechia1 site, 1 recruiting
- Recruiting
Brno University Hospital
Brno, 62500
Josef Bednařík, prof. MD, CSc., 532231481, bednarik.josef@fnbrno.cz
About this study
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)
- 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).
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.
- Conditions
- Delirium
- Being tested
- CAM-ICU, ICDSC, 4AT, p(s)CAM-ICU, CAPD
- Keywords
- delirium, delirium screening, ICU delirium
- Medical subject headings
- Delirium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAM-ICUDiagnostic test
Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.
ICDSCDiagnostic test
Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.
4ATDiagnostic test
Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.
p(s)CAM-ICUDiagnostic test
Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.
CAPDDiagnostic 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.
EEGDiagnostic test
Patients with positive delirium will undergo EEG examination. 10-min native EEG.
| Study group | Role | What they receive |
|---|---|---|
| Neurointensive/neurocritical group (N-ICU) | Not described Receives: 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) | Not described Receives: Diagnostic Test: p(s)CAM-ICU; Diagnostic Test: CAPD; Diagnostic Test: EEG |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants who develop ICU delirium
assessed by experienced neuro-intensivist
Measured: up to 14 days after admission
Secondary outcomes (4)
Length of stay in ICU
Measured: up to 10 weeks
Mortality
Measured: 6 months
Number of participants and severity of post-ICU dementia, cognitive impairment(Blessed dementia scale, BDS)
Measured: 6 months
Degree of functional dependency (Barthel index)
the higher score, the worse result meaning cognitive impairment and non-independence
Measured: up to 10 weeks and after 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jun 2023
- Study start7 Sep 2023
- Primary completionMay 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DeliriumStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Masaryk University
- Sponsor type
- University, hospital or other
- Collaborators
- Brno University Hospital, University Hospital, Motol
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05891873
- Sponsor's protocol ID
- DELUSION-DEEP-CZ
- Status last verified
- Oct 2023
- First submitted
- 17 May 2023
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations
- ClinicalTrials.gov ID
- NCT05891873
- Acronym / sponsor ID
- DELUSION-DEEP-CZ
- Conditions
- Delirium
- Keywords
- delirium, delirium screening, ICU delirium
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- Masaryk UniversityUniversity, hospital or other
- Collaborators
- Brno University Hospital, University Hospital, Motol
- Study start
- 7 Sep 2023 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 7 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Design
- Multicentre observational follow-up cohort study with 2 different cohorts and a minimum follow-up period of 6 months.
Recruitment (groups)
- 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).
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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).
Key inclusion criteria (2 listed)
- 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).
Key exclusion criteria (2 listed)
- (N-ICU) severe trauma with short life expectancy (days)
- duration of the ICU stay shorter than 24 hours
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAM-ICUPatients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above. | Diagnostic test | Neurointensive/neurocritical group (N-ICU) |
| ICDSCPatients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above. | Diagnostic test | Neurointensive/neurocritical group (N-ICU) |
| 4ATPatients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above. | Diagnostic test | Neurointensive/neurocritical group (N-ICU) |
| p(s)CAM-ICUPatients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above. | Diagnostic test | Paediatric intensive/critical group (P-ICU) |
| CAPDPatients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above. | Diagnostic test | Paediatric intensive/critical group (P-ICU) |
| MASTcz (The Mississippi Aphasia Screening Test)People with aphasia will be examined by a skilled speech therapist. | Diagnostic test | Neurointensive/neurocritical group (N-ICU) |
| EEGPatients with positive delirium will undergo EEG examination. 10-min native EEG. | Diagnostic test | Neurointensive/neurocritical group (N-ICU), Paediatric intensive/critical group (P-ICU) |
Primary outcome
Number of participants who develop ICU delirium
Time frame: up to 14 days after admission
assessed by experienced neuro-intensivist
4 secondary outcomes
Length of stay in ICU
Time frame: up to 10 weeks
Mortality
Time frame: 6 months
Number of participants and severity of post-ICU dementia, cognitive impairment(Blessed dementia scale, BDS)
Time frame: 6 months
Degree of functional dependency (Barthel index)
Time frame: up to 10 weeks and after 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Delirium, run by Masaryk University at 1 site in Czechia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Czechia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Josef Bednařík, prof. MD, CSc. (532231481, bednarik.josef@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants who develop ICU delirium (time frame: up to 14 days after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023.