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

Completed

• Conditions: Delirium

• Registration Number: NCT02518646
• Lead Sponsor: Radboud University Medical Center

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.

Study Timeline

• Study First Submitted: 2015-07-21
• Study First Submitted QC: 2015-08-05
• Study First Posted: 2015-08-10
• Study Start: 2015-09
• Primary Completion: 2016-12
• Study Completion: 2016-12
• Status Verified: 2017-01
• Last Update Submitted: 2017-05-17
• Last Update Posted: 2017-05-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2500

Inclusion Criteria

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

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of ICU delirium	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

Name	Time	Method
Delirium onset in a specified period	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)
Development of delirium	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).
Delirium subtype	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)
Delirium episodes	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.
Delirium duration	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).

Trial Locations

Locations (1)

Radboudumc; 🇳🇱 Nijmegen, Netherlands