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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

August 17, 2009
October 26, 2009
May 2009
September 2009   (final data collection date for primary outcome measure)
delirium [ Time Frame: during admission at the critical care ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00961389 on ClinicalTrials.gov Archive Site
markers of inflammation [ Time Frame: within 24 hours of delirium diagnosis ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Validating a Delirium Prediction Model for Critically Ill Patients
Validating a Delirium Prediction Model for Critically Ill Patients

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).

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

blood, urine

Non-Probability Sample

tertiary care clinic

Delirium
Not Provided
  • delirious patients
    minimal any positive CAM-ICU score during ICU admission
  • non-delirious patients
    without any positive CAM-ICU score during ICU admission
van den Boogaard M, Pickkers P, Slooter AJ, Kuiper MA, Spronk PE, van der Voort PH, van der Hoeven JG, Donders R, van Achterberg T, Schoonhoven L. Development and validation of PRE-DELIRIC (PREdiction of DELIRium in ICu patients) delirium prediction model for intensive care patients: observational multicentre study. BMJ. 2012 Feb 9;344:e420. doi: 10.1136/bmj.e420.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
650
October 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
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
Netherlands
 
NCT00961389
2007/283-2
No
M. van den Boogaard, MSc, RN, CCRN, Radboud University Nijmegen Medical Centre
Radboud University
Not Provided
Not Provided
Radboud University
August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP