We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Validating a Delirium Prediction Model for Critically Ill Patients

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.
ClinicalTrials.gov Identifier: NCT00961389
Recruitment Status : Unknown
Verified August 2009 by Radboud University.
Recruitment status was:  Recruiting
First Posted : August 19, 2009
Last Update Posted : October 27, 2009
Sponsor:
Information provided by:
Radboud University

Brief Summary:

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).


Condition or disease
Delirium

Study Type : Observational
Estimated Enrollment : 650 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validating a Delirium Prediction Model for Critically Ill Patients
Study Start Date : May 2009
Estimated Primary Completion Date : September 2009
Estimated Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
U.S. FDA Resources

Group/Cohort
delirious patients
minimal any positive CAM-ICU score during ICU admission
non-delirious patients
without any positive CAM-ICU score during ICU admission



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

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

Biospecimen Retention:   Samples With DNA
blood, urine


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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:

  • 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

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): NCT00961389


Contacts
Contact: Mark van den Boogaard, MSc, R< CCRN +31243655618 m.vandenboogaard@ic.umcn.nl
Contact: Peter Pickkers, MD, PhD +31243615363 p.pickkers@ic.umcn.nl

Locations
Netherlands
Radboud University Nijmegen Medical Centre, Critical Care Recruiting
Nijmegen, Gelderland, Netherlands
Contact: Mark vd Boogaard, MSc, Rn, CCRN    +31243655618    m.vandenboogaard@ic.umcn.nl   
Contact: Peter Pickkers, MD, PhD    +31243615363    p.pickkers@ic.umcn.nl   
Principal Investigator: Hans van der Hoeven, MD, PhD         
Sponsors and Collaborators
Radboud University

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: NCT00961389     History of Changes
Other Study ID Numbers: 2007/283-2
First Posted: August 19, 2009    Key Record Dates
Last Update Posted: October 27, 2009
Last Verified: August 2009

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

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