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

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ClinicalTrials.gov Identifier: NCT02518646
Recruitment Status : Completed
First Posted : August 10, 2015
Last Update Posted : May 19, 2017
Sponsor:
Information provided by (Responsible Party):
Radboud University

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.

Condition or disease
Delirium

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.

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Study Type : Observational
Actual Enrollment : 2500 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models
Study Start Date : September 2015
Actual Primary Completion Date : December 2016
Actual Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Delirium




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Delirium subtype [ Time Frame: During the first 14 days after ICU admission ]

    Hyperactive delirium is defined as patients with a persistent positive RASS assessment during the delirium episode (+1 to +4).

    Hypoactive delirium is defined as patients with a persistent neutral or negative RASS assessment during the delirium episode (0 to -3).

    Mixed delirium is defined as patients with both positive and negative RASS assessments during the delirium episode. (Peterson 2006)


  2. Delirium duration [ Time Frame: During the first 14 days after ICU admission ]
    The duration of delirium is defined as time (in days) from the first positive CAM-ICU/ICDSC or treatment with haloperidol or other anti-psychotics for delirium, until the beginning of two consecutive days of negative delirium screenings (negative CAM-ICU/ICDSC).

  3. Delirium episodes [ Time Frame: During the first 14 days after ICU admission ]
    Defined as the number of episodes a patient is screened positive for delirium. A delirium episode is defined as the time from first the positive delirium assessment, until the beginning of two consecutive days (48 hours) of negative delirium assessments.

  4. Delirium onset in a specified period [ Time Frame: During the first 14 days after ICU admission ]
    Based on the quartiles of the time to development of delirium at: day 0-1; day 2; day 3-6; >day 6. These quartiles are based on a former delirium prediction study (E-PRE-DELIRIC). (Wassenaar 2015)

  5. Development of delirium [ Time Frame: During the first 14 days after ICU admission ]
    Defined as ≥ 2 positive assessments for delirium within 48 hours (because of the fluctuating course of delirium).



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All patients aged ≥ 18 years (surgical, medical, neurology/neurosurgical, or trauma patients) a from the participating multinational ICUs. These ICU patients are at risk of developing the outcome of interest, delirium.
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.

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): NCT02518646


Locations
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Netherlands
Radboudumc
Nijmegen, Netherlands
Sponsors and Collaborators
Radboud University
Investigators
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Principal Investigator: Mark van den Boogaard, PhD, RN Radboud University
Principal Investigator: Annelies Wassenaar, MSc, RN Radboud University
Principal Investigator: Peter Pickkers, PhD, MD Radboud University
Principal Investigator: Lisette Schoonhoven, PhD University of Southampton
Publications of Results:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Radboud University
ClinicalTrials.gov Identifier: NCT02518646    
Other Study ID Numbers: IC_2015-1782
First Posted: August 10, 2015    Key Record Dates
Last Update Posted: May 19, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Radboud University:
Delirium
Intensive care unit
Adult
Clinical prediction
Additional relevant MeSH terms:
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Delirium
Confusion
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders