ClinicalTrials.gov
ClinicalTrials.gov Menu

International Validation of a Delirium Prediction Model for ICU Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01249755
Recruitment Status : Completed
First Posted : November 30, 2010
Last Update Posted : August 10, 2012
Sponsor:
Information provided by (Responsible Party):
Mark van den Boogaard, Radboud University

Brief 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.

Condition or disease
Delirium

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.

Study Type : Observational
Actual Enrollment : 2000 participants
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.
Study Start Date : November 2011
Actual Primary Completion Date : June 2012
Actual Study Completion Date : August 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium
U.S. FDA Resources

Group/Cohort
delirious patients
The cohort is divided in delirious and non-delirious patients



Primary Outcome Measures :
  1. delirium [ Time Frame: during admission at the critical care ]
    Delirium is defined as at minimum one positive CAM-ICU screening during the complete ICU stay



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01249755


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

Responsible Party: Mark van den Boogaard, PhD, Radboud University
ClinicalTrials.gov Identifier: NCT01249755     History of Changes
Other Study ID Numbers: 20110901
First Posted: November 30, 2010    Key Record Dates
Last Update Posted: August 10, 2012
Last Verified: August 2012

Additional relevant MeSH terms:
Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Neurocognitive Disorders
Mental Disorders