Validating a Delirium Prediction Model for Critically Ill Patients

Delirium Clinical Trial

Official title:

Validating a Delirium Prediction Model for Critically Ill Patients

Clinical Trial Details — Status: Unknown status

Administrative data

• NCT number: NCT00961389
• Other study ID #: 2007/283-2
• Status: Unknown status
• Phase: N/A
• First received: August 17, 2009
• Last updated: October 26, 2009
• Start date: May 2009
• Est. completion date: October 2009

Study information

• Verified date: August 2009
• Source: Radboud University
• Contact: Mark van den Boogaard, MSc, R< CCRN
• Phone: +31243655618
• Email: m.vandenboogaard[@]ic.umcn.nl
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Unknown status
• Enrollment: 650
• Est. completion date: October 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Critical Illness
• Delirium

Locations

Country	Name	City	State
Netherlands	Radboud University Nijmegen Medical Centre, Critical Care	Nijmegen	Gelderland

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delirium		during admission at the critical care
Secondary	markers of inflammation		within 24 hours of delirium diagnosis