DeliriumNCT00961389
Validating a Delirium Prediction Model for Critically Ill Patients
An observational study of Delirium, run by Radboud University Medical Center at 1 site in Netherlands.
Trial summary
The objective of this study is to determine the incidence of delirium in adults patients who are admitted at the critical care unit of a Dutch University Hospital with the mapping of relevant delirium risk factors The primary aim is to validate the investigators' developed delirium prediction model for critical care… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Delirium
- How many people
- 650 participants
- Where
- 1 siteNetherlands
- Study dates
- May 2009to Oct 2009
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: tertiary care clinic
Who may be able to join
- all adult patients (18 years and older) admitted at the critical care unit of our hospital
Who cannot join
- admitted < 12 hours on ICU
- not able to understand Dutch
- patients with serious hearing and visibility disabilities
- mentally retarded patients
- patients suffering from receptive aphasia
- delirious before admission
Trial locations and contacts
1 site in 1 country.
Netherlands1 site, 1 recruiting
- Recruiting
Radboud University Nijmegen Medical Centre, Critical Care
Nijmegen, Gelderland
Mark vd Boogaard, MSc, Rn, CCRN, +31243655618, m.vandenboogaard@ic.umcn.nl
Peter Pickkers, MD, PhD, +31243615363, p.pickkers@ic.umcn.nl
About this study
The objective of this study is to determine the incidence of delirium in adults patients who are admitted at the critical care unit of a Dutch University Hospital with the mapping of relevant delirium risk factors The primary aim is to validate the investigators' developed delirium prediction model for critical care patients.
A secondary aim is to find differences between delirious patients and non-delirious patients on different aspects of diagnostics, treatment and care, outcome, length of stay, and inflammation.
According to Dutch law, the need to obtain informed consent was waived by the Committee on Research Involving Human Subjects (CMO) of Nijmegen for this observational study (2007/283).
- Conditions
- Delirium
- Keywords
- delirium, critical care, risk factors, prediction, inflammation
- Medical subject headings
- Delirium, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| delirious patients | minimal any positive CAM-ICU score during ICU admission | |
| non-delirious patients | without any positive CAM-ICU score during ICU admission |
What is being measured
The primary outcome is the main question the study is designed to answer.
delirium
Measured: during admission at the critical care
Secondary outcomes (1)
markers of inflammation
Measured: within 24 hours of delirium diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2009 (estimated)
- Study startMay 2009
- Primary completionSep 2009 (estimated)
- Study completionOct 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Radboud University Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00961389
- Sponsor's protocol ID
- 2007/283-2
- Status last verified
- Aug 2009
- First submitted
- 17 Aug 2009
- Last updated
- 27 Oct 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
van den Boogaard M, Pickkers P, Slooter AJ, Kuiper MA, Spronk PE, van der Voort PH, van der Hoeven JG, Donders R, van Achterberg T, Schoonhoven L. Development and validation of PRE-DELIRIC (PREdiction of DELIRium in ICu patients) delirium prediction model for intensive care patients: observational multicentre study. BMJ. 2012 Feb 9;344:e420. doi: 10.1136/bmj.e420.
PubMed 22323509
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validating a Delirium Prediction Model for Critically Ill Patients
- ClinicalTrials.gov ID
- NCT00961389
- Acronym / sponsor ID
- 2007/283-2
- Conditions
- Delirium
- Keywords
- delirium, critical care, risk factors, prediction, inflammation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 650 participants (estimated)
- Lead sponsor
- Radboud University Medical CenterUniversity, hospital or other
- Study start
- May 2009
- Primary completion
- Sep 2009 (estimated)
- Study completion
- Oct 2009 (estimated)
- First posted
- 19 Aug 2009 (estimated)
- 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.
The objective of this study is to determine the incidence of delirium in adults patients who are admitted at the critical care unit of a Dutch University Hospital with the mapping of relevant delirium risk factors The primary aim is to validate the investigators' developed delirium prediction model for critical care patients.
A secondary aim is to find differences between delirious patients and non-delirious patients on different aspects of diagnostics, treatment and care, outcome, length of stay, and inflammation.
According to Dutch law, the need to obtain informed consent was waived by the Committee on Research Involving Human Subjects (CMO) of Nijmegen for this observational study (2007/283).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| delirious patients | – | –minimal any positive CAM-ICU score during ICU admission |
| non-delirious patients | – | –without any positive CAM-ICU score during ICU admission |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- tertiary care clinic
Key inclusion criteria (1 listed)
- all adult patients (18 years and older) admitted at the critical care unit of our hospital
Key exclusion criteria (6 listed)
- admitted < 12 hours on ICU
- not able to understand Dutch
- patients with serious hearing and visibility disabilities
- mentally retarded patients
- patients suffering from receptive aphasia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
delirium
Time frame: during admission at the critical care
1 secondary outcome
markers of inflammation
Time frame: within 24 hours of delirium diagnosis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2009.
- Derived from this study: PubMed 22323509van den Boogaard M, Pickkers P, Slooter AJ, Kuiper MA, Spronk PE, van der Voort PH, van der Hoeven JG, Donders R, van Achterberg T, Schoonhoven L. Development and validation of PRE-DELIRIC (PREdiction of DELIRium in ICu patients) delirium prediction model for intensive care patients: observational multicentre study. BMJ. 2012 Feb 9;344:e420. doi: 10.1136/bmj.e420.
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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. This study is not recruiting at the moment.
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 Radboud University Medical Center at 1 site in Netherlands.
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 1 inclusion and 6 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 27 Oct 2009. 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 Netherlands. 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 Mark van den Boogaard, MSc, R< CCRN (+31243655618, m.vandenboogaard@ic.umcn.nl), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
delirium (time frame: during admission at the critical care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00961389, which also lists 1 linked publication.
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 27 Oct 2009; AzTrials last refreshed its copy on 29 Oct 2026.