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

This study has been completed.
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00604773
First received: January 17, 2008
Last updated: August 30, 2010
Last verified: February 2009
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • delirium [ Time Frame: during admission at the critical care ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • markers of inflammation [ Time Frame: within 24 hours of delirium diagnosis ] [ Designated as safety issue: No ]
  • biomarkers [ Time Frame: within 24 hours of delirium diagnosis ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Radboud University

Additional 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
Study First Received: January 17, 2008
Last Updated: August 30, 2010
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 19, 2013