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Validating a Delirium Prediction Model for Critically Ill Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2009 by Radboud University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Radboud University
ClinicalTrials.gov Identifier:
NCT00961389
First received: August 17, 2009
Last updated: October 26, 2009
Last verified: August 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 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
Delirium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Validating a Delirium Prediction Model for Critically Ill Patients

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 ]

Biospecimen Retention:   Samples With DNA

blood, urine


Estimated Enrollment: 650
Study Start Date: May 2009
Estimated Study Completion Date: October 2009
Estimated Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
delirious patients
minimal any positive CAM-ICU score during ICU admission
non-delirious patients
without any positive CAM-ICU score 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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

No publications provided

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
Study First Received: August 17, 2009
Last Updated: October 26, 2009
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

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
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 23, 2013