Validating a Delirium Prediction Model for Critically Ill Patients

Verified by: Radboud University, August 2009
First Received: August 17, 2009 | Last Updated: October 26, 2009 | Phase: N/A | Start Date: May 2009
Overall Status: Recruiting | Estimated Enrollment: 650
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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...

Brief Summary

Official Title: “Validating a Delirium Prediction Model for Critically Ill Patients”

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
  • Study Primary Completion Date: September 2009

Arms, Groups and Cohorts in this Clinical Trial

  • : delirious patients
    • minimal any positive CAM-ICU score during ICU admission
  • : non-delirious patients
    • without any positive CAM-ICU score during ICU admission

Outcome Measures for this Clinical Trial

Primary Measures

  • delirium
    • Time Frame: during admission at the critical care
      Safety Issue?: No

Secondary Measures

  • markers of inflammation
    • Time Frame: within 24 hours of delirium diagnosis
      Safety Issue?: No

Criteria for Participation in this Clinical Trial

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Clinical Trial Investigator Information

Lead Investigator: Radboud University Other

Overall Clinical Trial Officials and Contacts

Overall Contact: Mark van den Boogaard, MSc, R< CCRN +31243655618 m.vandenboogaard@ic.umcn.nl

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00961389

Study ID Number: 2007/283-2

ClinicalTrials.gov Identifier: NCT00961389

Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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