CClinicalTrials.gg
Status unknownNCT00961389Updated Oct 27, 2009

Validating a Delirium Prediction Model for Critically Ill Patients

An observational study in Delirium, sponsored by Radboud University Medical Center. Status unknown at 1 site in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2009-10-27.

Sponsored by Radboud University Medical Center · Observational

The sponsor has not verified this record recently (last verified Aug 2009), so the status shown — last known as Recruiting — may be out of date.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
650
Ages
18 Years and older
Sex
All
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Study 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 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).

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Conditions studied

  • Delirium

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Keywords

  • delirium
  • critical care
  • risk factors
  • prediction
  • inflammation
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In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's planned enrollment of 650 is above the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Radboud University Medical Center is the lead sponsor of 959 studies on the registry; 134 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

tertiary care clinic

Inclusion criteria

  • all adult patients (18 years and older) admitted at the critical care unit of our hospital

Exclusion criteria

Exclusion Criteria:

  • 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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
650 participants (estimated)
Biospecimen retention
Samples with dna

Groups and cohorts

  • delirious patients

    minimal any positive CAM-ICU score during ICU admission

  • non-delirious patients

    without any positive CAM-ICU score during ICU admission

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What researchers measure

Primary outcomes

  1. delirium

    Time frame: during admission at the critical care

Secondary outcomes

  1. markers of inflammation

    Time frame: within 24 hours of delirium diagnosis

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Study locations

1 of 1 sites recruiting
  • Radboud University Nijmegen Medical Centre, Critical Care
    Nijmegen, Gelderland, Netherlands
    Recruiting
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References and documents

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 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 27, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00961389
Lead sponsor
Radboud University Medical Center
First posted
Aug 19, 2009
Start date
May 2009
Primary completion
Sep 2009 (estimated)
Completion
Oct 2009 (estimated)
Last update
Oct 27, 2009

Study contacts

Mark van den Boogaard, MSc, R< CCRN
Contact
m.vandenboogaard@ic.umcn.nl
+31243655618
Peter Pickkers, MD, PhD
Contact
p.pickkers@ic.umcn.nl
+31243615363

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Aug 2009. You cannot join it, but the record below documents what was studied.

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