International Validation of a Delirium Prediction Model for ICU Patients

Delirium Clinical Trial

Official title:

International Validation of a Delirium Prediction Model for ICU Patients (PRE-DELIRIC) in ICUs; a Multicentre Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01249755
• Other study ID #: 20110901
• Status: Completed
• Phase: N/A
• First received: November 26, 2010
• Last updated: August 9, 2012
• Start date: November 2011
• Est. completion date: August 2012

Study information

• Verified date: August 2012
• 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

Recently our ICU research group developed and validated a delirium prediction model in the NetherlandsThis. This model has a high predictive value. We want to examine what the predictive value is in ICUs of other European countries.

Description:

Delirium is a serious and common disorder in ICU patients. It is increasingly recognized that screening of ICU patients is a valuable tool for early detection and treatment of delirium, which may reduce its incidence, severity and duration. Apart from treatment of delirium, delirium prevention (pharmacological and nursing interventions)is an important issue. However, it is time consuming to take preventive measures in all ICU patients. The recently developed prediction model facilitates the conduct of preventive measures focused on high risk groups. This prediction model is developed and validated in the Netherlands. The aim of our study is to investigate the predictive value of the model in ICUs in other countries.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2000
• Est. completion date: August 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• patients 18 years or older

Exclusion Criteria:

• delirious state within the first 24hours after ICU admission

• sustained comatose during complete ICU stay

• admission duration less than twelve hours;

• serious auditory or visual disorders

• unable to understand the language of the included centre

• severely mentally disabled

• serious receptive aphasia

• or if there are missing or incomplete delirium screenings during admission to the ICU

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	delirium	Delirium is defined as at minimum one positive CAM-ICU screening during the complete ICU stay	during admission at the critical care	No