Incidence of Delirium in Critically Ill Patients in a Dutch University Hospital

Delirium Clinical Trial

Official title:

Incidence of Delirium in Critically Ill Patients in a Dutch University Hospital

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00604773
• Other study ID #: Radboud 2007/283
• Status: Completed
• Phase: N/A
• First received: January 17, 2008
• Last updated: August 30, 2010
• Start date: February 2008
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• 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.

The primary aim is to determine the incidence of delirium and to determine risk factors for this group of patients to develop a prediction model.

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: Completed
• Enrollment: 700
• Est. completion date: February 2009
• Est. primary completion date: February 2009
• Accepts healthy volunteers: No
• Gender: Both
• 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:

• not able to understand Dutch

• patients with serious hearing and visibility disabilities

• mentally retarded patients

Study Design

Observational Model: Cohort, Time Perspective: Prospective

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	No
Secondary	markers of inflammation		within 24 hours of delirium diagnosis	No
Secondary	biomarkers		within 24 hours of delirium diagnosis	No