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Validating a Delirium Prediction Model for Critically Ill Patients

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Radboud University.
Recruitment status was:  Recruiting
Information provided by:
Radboud University Identifier:
First received: August 17, 2009
Last updated: October 26, 2009
Last verified: August 2009

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 Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validating a Delirium Prediction Model for Critically Ill Patients

Resource links provided by NLM:

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • delirium [ Time Frame: during admission at the critical care ]

Secondary Outcome Measures:
  • markers of inflammation [ Time Frame: within 24 hours of delirium diagnosis ]

Biospecimen Retention:   Samples With DNA
blood, urine

Estimated Enrollment: 650
Study Start Date: May 2009
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
delirious patients
minimal any positive CAM-ICU score during ICU admission
non-delirious patients
without any positive CAM-ICU score during ICU admission


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00961389

Contact: Mark van den Boogaard, MSc, R< CCRN +31243655618
Contact: Peter Pickkers, MD, PhD +31243615363

Radboud University Nijmegen Medical Centre, Critical Care Recruiting
Nijmegen, Gelderland, Netherlands
Contact: Mark vd Boogaard, MSc, Rn, CCRN    +31243655618   
Contact: Peter Pickkers, MD, PhD    +31243615363   
Principal Investigator: Hans van der Hoeven, MD, PhD         
Sponsors and Collaborators
Radboud University
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: M. van den Boogaard, MSc, RN, CCRN, Radboud University Nijmegen Medical Centre Identifier: NCT00961389     History of Changes
Other Study ID Numbers: 2007/283-2
Study First Received: August 17, 2009
Last Updated: October 26, 2009

Keywords provided by Radboud University:
critical care
risk factors

Additional relevant MeSH terms:
Critical Illness
Disease Attributes
Pathologic Processes
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders processed this record on September 18, 2017