NCT01249755

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Nov 2011

Shorter than P25 for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 26, 2010

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 30, 2010

Completed
11 months until next milestone

Study Start

First participant enrolled

November 1, 2011

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2012

Completed
Last Updated

August 10, 2012

Status Verified

August 1, 2012

Enrollment Period

7 months

First QC Date

November 26, 2010

Last Update Submit

August 9, 2012

Conditions

Delirium

Outcome Measures

Primary Outcomes (1)

  • delirium

    Delirium is defined as at minimum one positive CAM-ICU screening during the complete ICU stay

    during admission at the critical care

Study Arms (1)

delirious patients

The cohort is divided in delirious and non-delirious patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult patients admitted to the ICU

You may qualify if:

  • patients 18 years or older

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

ConfusionNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental Disorders

Study Officials

  • Mark van den Boogaard, MSc

    Radboud University Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PhD

Study Record Dates

First Submitted

November 26, 2010

First Posted

November 30, 2010

Study Start

November 1, 2011

Primary Completion

June 1, 2012

Study Completion

August 1, 2012

Last Updated

August 10, 2012

Record last verified: 2012-08