DeliriumDELUSIONNCT05841368
DELIRIUM SCREENING, INCIDENCE AND MANAGEMENT OBSERVATIONAL STUDY IN 2024 - THE CZECH REPUBLIC
An observational study of Delirium, run by Brno University Hospital at 1 site in Czechia.
Trial summary
Delirium in intensive care unit (ICU) settings is a frequent complication with reported prevalence of 31%. Recent data has revealed the connection between delirium and increased 30days mortality after hospital release and the higher incidence of readmission to emergency. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Delirium
- What is being tested?
- CAM-ICU and pCAM-ICU
- How many people
- 2,000 participants
- Where
- 1 siteCzechia
- Study dates
- 1 Jan 2024to 31 Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
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: ICU patients
Who may be able to join
- Patients in ICU settings
- in defined time interval of the study
Who cannot join
- duration of ICU stay shorter than 24 hours
Trial locations and contacts
1 site in 1 country.
About this study
Delirium in intensive care unit (ICU) settings is a frequent complication with reported prevalence of 31%. Recent data has revealed the connection between delirium and increased 30days mortality after hospital release and the higher incidence of readmission to emergency. Despite the high prevalence and well described validation methods for screening, the precise incidence remains unclear due to insufficient screening in ICU settings. The incidence of delirium in Czech Republic remains undescribed, beside data reported from neurointensive care patients and single-center general critically ill patients data.
Read the detailed description
All patients fulfilling inclusion criteria in intensive care settings in involved ICUs in Czech Republic will be included into the study. Data will be recorded for 1 consequent month. Basic demography will be evaluated. In each patient standard delirium screening based on the institutional ICU rules will be performed. If no screening method were set,Confusion Assessment Method - CAM-ICU for adult and pediatric Confusion Assessment Method -pCAM-ICU for pediatric patients would be used together with delirium management, restrain procedures, sedative/neuroleptics administration, 28-days mortality. All data will be recorded into to predefined eCRF.
- Conditions
- Delirium
- Being tested
- CAM-ICU, pCAM-ICU
- Keywords
- Delirium, Screening, Therapy, CAM-ICU
- 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
Also called delirium screening
Delirium in adult patients will be screened according to CAM-ICU
pCAM-ICUDiagnostic test
Also called delirium screening
Delirium in adult patients will be screened according to pCAM-ICU
| Study group | Role | What they receive |
|---|---|---|
| Adult ICU patients | Adult patients in ICU setting Receives: Diagnostic Test: CAM-ICU | |
| Pediatric ICU patients | Pediatric patients in ICU setting Receives: Diagnostic Test: pCAM-ICU |
What is being measured
The primary outcome is the main question the study is designed to answer.
Delirium prevalence
Delirium prevalence by CAM-ICU and pCAM-ICU will be screened in defined time interval
Measured: during 30 days after study initiation in selected ICU
Secondary outcomes (4)
Delirium management
Management of delirium will be evaluated
Measured: during 30 days after study initiation in selected ICU
Inhospital mortality
Inhospital mortality will be evaluated
Measured: during 30 days after study initiation in selected ICU
28-days mortality
28-days mortality will be evaluated
Measured: after patient inclusion into the study
90-days mortality
long term mortality will be evaluated
Measured: after patient inclusion into the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2023
- Study start1 Jan 2024 (estimated)
- Primary completion31 Jul 2024 (estimated)
- Study completion31 Jul 2024 (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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brno University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Masaryk University
- Responsible party
- Principal investigator, Petr Štourač, MD, Brno University Hospital
- Investigators
- Petr Stourac, prof. MD., Ph.D., MBA, Study chair, Department of paediatric anaesthesia and intensive care medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05841368
- Sponsor's protocol ID
- DELUSION-24-CZ
- Acronym
- DELUSION
- Status last verified
- Apr 2023
- First submitted
- 22 Apr 2023
- Last updated
- 3 May 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 3 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- DELIRIUM SCREENING, INCIDENCE AND MANAGEMENT OBSERVATIONAL STUDY IN 2024 - THE CZECH REPUBLIC
- ClinicalTrials.gov ID
- NCT05841368
- Acronym / sponsor ID
- DELUSION / DELUSION-24-CZ
- Conditions
- Delirium
- Keywords
- Delirium, Screening, Therapy, CAM-ICU
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Brno University HospitalUniversity, hospital or other
- Collaborators
- Masaryk University
- Study start
- 1 Jan 2024 (estimated)
- Primary completion
- 31 Jul 2024 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 3 May 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.
Delirium in intensive care unit (ICU) settings is a frequent complication with reported prevalence of 31%. Recent data has revealed the connection between delirium and increased 30days mortality after hospital release and the higher incidence of readmission to emergency. Despite the high prevalence and well described validation methods for screening, the precise incidence remains unclear due to insufficient screening in ICU settings. The incidence of delirium in Czech Republic remains undescribed, beside data reported from neurointensive care patients and single-center general critically ill patients data.
Detailed description
All patients fulfilling inclusion criteria in intensive care settings in involved ICUs in Czech Republic will be included into the study. Data will be recorded for 1 consequent month. Basic demography will be evaluated. In each patient standard delirium screening based on the institutional ICU rules will be performed. If no screening method were set,Confusion Assessment Method - CAM-ICU for adult and pediatric Confusion Assessment Method -pCAM-ICU for pediatric patients would be used together with delirium management, restrain procedures, sedative/neuroleptics administration, 28-days mortality. All data will be recorded into to predefined eCRF.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adult ICU patients | – | Diagnostic Test: CAM-ICUAdult patients in ICU setting |
| Pediatric ICU patients | – | Diagnostic Test: pCAM-ICUPediatric patients in ICU setting |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- ICU patients
Key inclusion criteria (2 listed)
- Patients in ICU settings
- in defined time interval of the study
Key exclusion criteria (1 listed)
- duration of 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-ICUAlso: delirium screeningDelirium in adult patients will be screened according to CAM-ICU | Diagnostic test | Adult ICU patients |
| pCAM-ICUAlso: delirium screeningDelirium in adult patients will be screened according to pCAM-ICU | Diagnostic test | Pediatric ICU patients |
Primary outcome
Delirium prevalence
Time frame: during 30 days after study initiation in selected ICU
Delirium prevalence by CAM-ICU and pCAM-ICU will be screened in defined time interval
4 secondary outcomes
Delirium management
Time frame: during 30 days after study initiation in selected ICU
Inhospital mortality
Time frame: during 30 days after study initiation in selected ICU
28-days mortality
Time frame: after patient inclusion into the study
90-days mortality
Time frame: after patient inclusion into the study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2023.
- Individual participant dataSharing planned: Undecided
Related trials for Delirium
RecruitingObservational study
The Impact of Fast-Track Anesthesia on Postoperative Neurocognitive Function in Patients Undergoing Cardiac Surgery
Delirium - Postoperative, Cardiac Surgery
Not yet recruiting
Prediction and Prevention of Postoperative Mortality and Morbidity
Dementia, Postoperative Delirium (POD)
Active, not recruitingPhase 3
The Danish Out-of-Hospital Cardiac Arrest Study
Out-Of-Hospital Cardiac Arrest, Post-Cardiac Arrest Syndrome
RecruitingPhase 3
Lactium Premedication to Prevent Emergence Agitation
Lactium, Premedication
Not yet recruiting
DEXmedetomidine for Postoperative Analgesia and Delirium Prevention After NEUROsurgery (DEX-NEURO Trial)
Neurosurgery, Brain Cancer
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. This study is not recruiting at the moment.
Petr Stourac, prof. MD., Ph.D., MBA study chair
Department of paediatric anaesthesia and intensive care medicine
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 Brno University Hospital 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 1 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: status not confirmed, as of the sponsor's last update on 3 May 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jozef UO Klučka, assoc.prof.MD., Ph.D. (+420532234696, klucka.jozef@fnbrno.cz), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Delirium prevalence (time frame: during 30 days after study initiation in selected ICU). 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 3 May 2023.