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Clinical Trials/NCT02518646
NCT02518646
Completed
Not Applicable

DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models

Radboud University Medical Center1 site in 1 country2,500 target enrollmentSeptember 2015
ConditionsDelirium

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Radboud University Medical Center
Enrollment
2500
Locations
1
Primary Endpoint
Development of ICU delirium
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

Currently, two ICU delirium prediction models are available: the PRE-DELIRIC model and the early prediction model (E-PRE-DELRIC). However, the use of these prediction models is not yet implemented as standard in clinical practice, as it is unknown which delirium prediction model can best be used to predict delirium in ICU patients.Therefore the main aim of this study is to compare the performance of the PRE-DELIRIC model and the E-PRE-DELRIC model.

Detailed Description

Delirium often occurs in ICU patients and is associated with negative consequences, requiring prevention. A prediction model facilitates the identification of those patients at risk for delirium and therefore need prevention the most. At present, two ICU delirium prediction models are available. First the PRE-DELIRIC model was developed. This recently recalibrated model reliably predicts ICU patients' risk for delirium within 24 hours after ICU admission. Because a relevant number of patients develops delirium during the first 24 hours after ICU admission, and prevention ideally should be deployed as soon as possible, the investigators developed the 'early prediction model' (E-PRE-DELIRIC) which reliably predicts delirium immediately after ICU admission. To implement a delirium prediction model in clinical practice, one needs to know which model best can be used. Currently, the use of a delirium prediction model is not implemented as standard in clinical practice, as this information is unavailable. Therefore the main aim of this study is to compare the (predictive and clinical) performance of the PRE-DELIRIC model and the E-PRE-DELRIC model.

Registry
clinicaltrials.gov
Start Date
September 2015
End Date
December 2016
Last Updated
8 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • ICU patients aged ≥18 years;
  • Surgical, medical, neurology/neurosurgical, or trauma patients.

Exclusion Criteria

  • Delirious at ICU admission;
  • Expected ICU stay shorter than 6 hours;
  • Unable to reliably assess ICU delirium due to:
  • sustained coma during entire ICU stay;
  • unable to understand the language spoken;
  • severely mentally disabled;
  • serious receptive aphasia;
  • serious auditory or visual disorders.

Outcomes

Primary Outcomes

Development of ICU delirium

Time Frame: During the first 14 days after ICU admission

Defined as a positive assessment for delirium and/or when a patient is treated with haloperidol or other anti-psychotics for delirium (and unable to be assessed).

Secondary Outcomes

  • Delirium onset in a specified period(During the first 14 days after ICU admission)
  • Development of delirium(During the first 14 days after ICU admission)
  • Delirium subtype(During the first 14 days after ICU admission)
  • Delirium episodes(During the first 14 days after ICU admission)
  • Delirium duration(During the first 14 days after ICU admission)

Study Sites (1)

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