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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604773
First Posted: January 30, 2008
Last Update Posted: August 31, 2010
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Radboud University
  Purpose

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).


Condition
Delirium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Incidence of Delirium in Critically Ill Patients in a Dutch University Hospital

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 ]
  • biomarkers [ Time Frame: within 24 hours of delirium diagnosis ]

Biospecimen Retention:   Samples With DNA
blood, urine

Estimated Enrollment: 700
Study Start Date: February 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
delirious patients
minimal one positive CAM-ICU score during ICU admission
non-delirious patients
without any positive CAM-ICU scores during ICU admission

  Eligibility

Information from the National Library of Medicine

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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
Criteria

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604773


Locations
Netherlands
Radboud University Nijmegen Medical Centre, Critical Care
Nijmegen, Gelderland, Netherlands, 6500
Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Hans vd Hoeven, MD, PhD Radboud University
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: M. van den Boogaard, MSc, RN, CCRN, Radboud University Nijmegen Medical Centre
ClinicalTrials.gov Identifier: NCT00604773     History of Changes
Other Study ID Numbers: Radboud 2007/283
First Submitted: January 17, 2008
First Posted: January 30, 2008
Last Update Posted: August 31, 2010
Last Verified: February 2009

Keywords provided by Radboud University:
delirium
critical care
risk factors
prediction

Additional relevant MeSH terms:
Critical Illness
Delirium
Disease Attributes
Pathologic Processes
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders