Validating a Delirium Prediction Model for Critically Ill Patients

NCT ID: NCT00961389

Last Updated: 2009-10-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

650 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-05-31

Study Completion Date

2009-10-31

Brief Summary

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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).

Detailed Description

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Conditions

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Delirium

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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delirious patients

minimal any positive CAM-ICU score during ICU admission

No interventions assigned to this group

non-delirious patients

without any positive CAM-ICU score during ICU admission

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Radboud University Medical Center

OTHER

Sponsor Role lead

Responsible Party

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Radboud University Nijmegen Medical Centre

Locations

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Radboud University Nijmegen Medical Centre, Critical Care

Nijmegen, Gelderland, Netherlands

Site Status RECRUITING

Countries

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Netherlands

Central Contacts

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Mark van den Boogaard, MSc, R< CCRN

Role: CONTACT

+31243655618

Peter Pickkers, MD, PhD

Role: CONTACT

+31243615363

Facility Contacts

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Mark vd Boogaard, MSc, Rn, CCRN

Role: primary

+31243655618

Peter Pickkers, MD, PhD

Role: backup

+31243615363

References

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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.

Reference Type DERIVED
PMID: 22323509 (View on PubMed)

Other Identifiers

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2007/283-2

Identifier Type: -

Identifier Source: org_study_id

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