Incidence of Delirium in Critically Ill Patients in a Dutch University Hospital

Verified by: Radboud University, February 2009
First Received: January 17, 2008 | Last Updated: August 30, 2010 | Phase: N/A | Start Date: February 2008
Overall Status: Completed | Estimated Enrollment: 700
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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. The primary aim is to determine the incidence of delirium and to determine risk factors for this group of patients to develop a prediction model. A secondary aim is to find differences between delirious patients and non-delirious...

Brief Summary

Official Title: “Incidence of Delirium in Critically Ill Patients in a Dutch University Hospital”

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.

The primary aim is to determine the incidence of delirium and to determine risk factors for this group of patients to develop a prediction model.

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: February 2009

Arms, Groups and Cohorts in this Clinical Trial

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

  • not able to understand Dutch
  • patients with serious hearing and visibility disabilities
  • mentally retarded patients

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

Hans vd Hoeven, MD, PhD Principal Investigator Radboud University  

Additional Information

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00604773

Study ID Number: Radboud 2007/283

ClinicalTrials.gov Identifier: NCT00604773

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

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