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International Validation of a Delirium Prediction Model for ICU Patients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Mark van den Boogaard, Radboud University
ClinicalTrials.gov Identifier:
NCT01249755
First received: November 26, 2010
Last updated: August 9, 2012
Last verified: August 2012
History of Changes
  Purpose

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.


Condition
Delirium

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: International Validation of a Delirium Prediction Model for ICU Patients (PRE-DELIRIC) in ICUs; a Multicentre Trial.

Resource links provided by NLM:

MedlinePlus related topics: Delirium
U.S. FDA Resources

Further study details as provided by Radboud University:

Primary Outcome Measures:
  • delirium [ Time Frame: during admission at the critical care ] [ Designated as safety issue: No ]
    Delirium is defined as at minimum one positive CAM-ICU screening during the complete ICU stay


Enrollment: 2000
Study Start Date: November 2011
Study Completion Date: August 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
delirious patients
The cohort is divided in delirious and non-delirious patients

Detailed 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Adult patients admitted to the ICU

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01249755

Sponsors and Collaborators
Radboud University
Investigators
Principal Investigator: Mark van den Boogaard, MSc Radboud University
  More Information

No publications provided

Responsible Party: Mark van den Boogaard, PhD, Radboud University
ClinicalTrials.gov Identifier: NCT01249755     History of Changes
Other Study ID Numbers: 20110901
Study First Received: November 26, 2010
Last Updated: August 9, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
 Nervous System Diseases
Signs and Symptoms
Delirium, Dementia, Amnestic, Cognitive Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013