Clinical trial NCT00604773: Incidence of Delirium in Critically Ill Patients in a Dutch University Hospital
Official title: Incidence of Delirium in Critically Ill Patients in a Dutch University Hospital
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: delirium
critical care
risk factors
prediction
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2008-01-30
Enrollment: 700
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: tertiary care clinic

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: delirium
timeFrame: during admission at the critical care
Secondary outcomes:
measure: markers of inflammation
timeFrame: within 24 hours of delirium diagnosis
measure: biomarkers
timeFrame: within 24 hours of delirium diagnosis
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboud University Nijmegen Medical Centre, Critical Care
state: Gelderland
Study officials:
affiliation: Radboud University Medical Center
name: Hans vd Hoeven, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: van den Boogaard M, Kox M, Quinn KL, van Achterberg T, van der Hoeven JG, Schoonhoven L, Pickkers P. Biomarkers associated with delirium in critically ill patients and their relation with long-term subjective cognitive dysfunction; indications for different pathways governing delirium in inflamed and noninflamed patients. Crit Care. 2011;15(6):R297. doi: 10.1186/cc10598. Epub 2011 Dec 29.
citation: van den Boogaard M, van Swelm RP, Russel FG, Heemskerk S, van der Hoeven JG, Masereeuw R, Pickkers P. Urinary protein profiling in hyperactive delirium and non-delirium cardiac surgery ICU patients. Proteome Sci. 2011 Mar 22;9:13. doi: 10.1186/1477-5956-9-13.