DeliriumNCT05084482
External Validation of Delirium Prediction Models for Intensive Care Patients
An observational study of Delirium, run by Zealand University Hospital at 1 site in Denmark.
Trial summary
Delirium is frequently observed among critically ill patients and is associated with detrimental outcomes. Currently, no evidence-based prevention or treatment exists for delirium, and especially, the inability to identify effective preventive measures of delirium has increased the focus on identifying patients with a… Read more about this study
- Who is it for?
- Ages 18 to 110 years
- Conditions the study is for
- Delirium
- What is being tested?
- Prediction models
- How many people
- 660 participants
- Where
- 1 siteDenmark
- Study dates
- 1 Jan 2022to 30 Sep 2023
- 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 18 to 110 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: All adult patients admitted to participating ICUs in the Zealand Region between November 2021 and July 2022.
Who may be able to join
- Acute admission to an ICU AND
- Age > 18 of years
Who cannot join
- Total admittance to the ICU less than 24 hours
- Delirium assessment nonapplicable (hearing or visual disabilities, language barriers, or mentally incompetent
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Zealand University Hospital, Department of Anaesthesiology
Køge, Zealand Region of Denmark, 4600
About this study
Official title: External Validation of Delirium Prediction Models for Intensive Care Patients. A Prospective, Multicenter, Cohort Study
Delirium is frequently observed among critically ill patients and is associated with detrimental outcomes. Currently, no evidence-based prevention or treatment exists for delirium, and especially, the inability to identify effective preventive measures of delirium has increased the focus on identifying patients with a high risk of delirium through prediction models. Two prediction models have been developed to estimate the risk of delirium in ICU patients: the prediction model for delirium (PRE-DELIRIC) and the early prediction model for delirium (E-PRE-DELIRIC). These robust and well-calibrated prediction models have the potential of assisting in identifying patients with the highest risk for delirium and thereby to focusing preventive strategies on the most vulnerable group. However further validation is needed in a Danish population.
Read the detailed description
Adult ICU patients admitted to the participating ICUs in the Region Zealand are included according to eligibility.
Eligible patients will be assessed with E-PREDELIRIC at admission to the ICU and PREDELIRIC 24h after admission to the ICU. Patients will be screened twice daily with CAM-ICU until ICU discharge, death, transferal to non-participating ICU or for a maximum observation period of 14 days.
Central screening via EPIC PDM and registration in central database (REDCap, ZUH) by the principal investigator.
The following are registered: Age, sex, history of cognitive impairment, history of alcohol abuse, admission category, urgent admission, mean arterial blood pressure at the time of ICU admission, use of corticosteroids, respiratory failure, Blood Urea Nitrogen/Carbamide, APACHE-II score, administered morphine does, use of sedatives, metabolic acidosis, coma, presence of infection, delirium status by CAM-ICU, time of ventilation, length of ICU and hospital stay, mortality.
- Conditions
- Delirium
- Being tested
- Prediction models
- Keywords
- Critical illness, ICU, Delirium, prediction, Observational
- Medical subject headings
- Delirium, Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prediction modelsOther
Also called Delirium, PRE-DELIRIC, E-PRE-DELIRIC
The prediction scores are validated by the CAM-ICU scores up to 14 days after ICU admission.
| Study group | Role | What they receive |
|---|---|---|
| Adult patients admitted to Intensive Care Unit (ICU) | Eligible patients are scored by E-PRE-DELIRIC at admission and PRE-DELIRIC 24 hours after admission. Receives: Other: Prediction models |
What is being measured
The primary outcome is the main question the study is designed to answer.
AUROC for PRE-DELIRIC
Area Under the Receiver Operating Characteristics (AUROC) for PRE-DELIRIC
Measured: Duration of the study, november 2021 to september 2022
AUROC for E-PRE-DELIRIC
Area Under the Receiver Operating Characteristics (AUROC) for E-PRE-DELIRIC
Measured: Based on 14 days of ICU admission
Secondary outcomes (4)
30-days mortality
Dead or alive at day 30 after ICU admission
Measured: 30 days efter ICU admission
Time on ventilator
Days in need of mechanical ventilation up to 14 days of ICU admission
Measured: 14 days after ICU admission
ICU length of stay
Days in the ICU up to 30 days
Measured: 30 days after ICU admission
Hospital length of stay
Days in the hospital up to 30 days after ICU admission
Measured: 30 days after ICU admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2021
- Study start1 Jan 2022
- Primary completion31 Jul 2023
- Study completion30 Sep 2023
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.
- More trials run by Zealand University HospitalThe sponsor's other registered studies.
- 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
- 660 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zealand University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lone Musaeus Poulsen, Zealand University Hospital
- Investigators
- Neeliya Anton Joseph, BSc Medicine, Principal investigator, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05084482
- Sponsor's protocol ID
- ZUH.01
- Status last verified
- Jan 2023
- First submitted
- 6 Oct 2021
- Last updated
- 8 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Individual anonymised participant data will be made available to researchers upon reasonable request after termination and publication of the study.
Study at a glance
From the registry record, last updated by the sponsor on 8 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Validation of Delirium Prediction Models for Intensive Care Patients. A Prospective, Multicenter, Cohort Study
- ClinicalTrials.gov ID
- NCT05084482
- Acronym / sponsor ID
- ZUH.01
- Conditions
- Delirium
- Keywords
- Critical illness, ICU, Delirium, prediction, Observational
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 660 participants (actual)
- Lead sponsor
- Zealand University HospitalUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 31 Jul 2023 (actual)
- Study completion
- 30 Sep 2023 (actual)
- First posted
- 19 Oct 2021 (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 is frequently observed among critically ill patients and is associated with detrimental outcomes. Currently, no evidence-based prevention or treatment exists for delirium, and especially, the inability to identify effective preventive measures of delirium has increased the focus on identifying patients with a high risk of delirium through prediction models. Two prediction models have been developed to estimate the risk of delirium in ICU patients: the prediction model for delirium (PRE-DELIRIC) and the early prediction model for delirium (E-PRE-DELIRIC). These robust and well-calibrated prediction models have the potential of assisting in identifying patients with the highest risk for delirium and thereby to focusing preventive strategies on the most vulnerable group. However further validation is needed in a Danish population.
Detailed description
Adult ICU patients admitted to the participating ICUs in the Region Zealand are included according to eligibility.
Eligible patients will be assessed with E-PREDELIRIC at admission to the ICU and PREDELIRIC 24h after admission to the ICU. Patients will be screened twice daily with CAM-ICU until ICU discharge, death, transferal to non-participating ICU or for a maximum observation period of 14 days.
Central screening via EPIC PDM and registration in central database (REDCap, ZUH) by the principal investigator.
The following are registered: Age, sex, history of cognitive impairment, history of alcohol abuse, admission category, urgent admission, mean arterial blood pressure at the time of ICU admission, use of corticosteroids, respiratory failure, Blood Urea Nitrogen/Carbamide, APACHE-II score, administered morphine does, use of sedatives, metabolic acidosis, coma, presence of infection, delirium status by CAM-ICU, time of ventilation, length of ICU and hospital stay, mortality.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult patients admitted to Intensive Care Unit (ICU) | – | Other: Prediction modelsEligible patients are scored by E-PRE-DELIRIC at admission and PRE-DELIRIC 24 hours after admission. |
Who may qualify
- Ages
- 18 to 110 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All adult patients admitted to participating ICUs in the Zealand Region between November 2021 and July 2022.
Key inclusion criteria (2 listed)
- Acute admission to an ICU AND
- Age > 18 of years
Key exclusion criteria (2 listed)
- Total admittance to the ICU less than 24 hours
- Delirium assessment nonapplicable (hearing or visual disabilities, language barriers, or mentally incompetent
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 |
|---|---|---|
| Prediction modelsAlso: Delirium, PRE-DELIRIC, E-PRE-DELIRICThe prediction scores are validated by the CAM-ICU scores up to 14 days after ICU admission. | Other | Adult patients admitted to Intensive Care Unit (ICU) |
Primary outcome
AUROC for PRE-DELIRIC
Time frame: Duration of the study, november 2021 to september 2022
Area Under the Receiver Operating Characteristics (AUROC) for PRE-DELIRIC
AUROC for E-PRE-DELIRIC
Time frame: Based on 14 days of ICU admission
Area Under the Receiver Operating Characteristics (AUROC) for E-PRE-DELIRIC
4 secondary outcomes
30-days mortality
Time frame: 30 days efter ICU admission
Time on ventilator
Time frame: 14 days after ICU admission
ICU length of stay
Time frame: 30 days after ICU admission
Hospital length of stay
Time frame: 30 days after ICU admission
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Apr 2025.
- Individual participant dataSharing planned: Yes. Individual anonymised participant data will be made available to researchers upon reasonable request after termination and publication of the study.
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.
Neeliya Anton Joseph, BSc Medicine principal investigator
Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark
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 Zealand University Hospital at 1 site in Denmark.
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: finished, as of the sponsor's last update on 8 Apr 2025. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AUROC for PRE-DELIRIC (time frame: Duration of the study, november 2021 to september 2022). The study lists 2 primary outcomes in all. 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 8 Apr 2025.