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

Delirium Clinical Trial

— DECISION  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02518646
• Other study ID #: IC_2015-1782
• Status: Completed
• Phase: N/A
• First received: July 21, 2015
• Last updated: May 17, 2017
• Start date: September 2015
• Est. completion date: December 2016

Study information

• Verified date: January 2017
• Source: Radboud University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: December 2016
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Delirium

Locations

Country	Name	City	State
Netherlands	Radboudumc	Nijmegen

Sponsors (1)

Lead Sponsor	Collaborator
Radboud University

Country where clinical trial is conducted

Netherlands, 

References & Publications (3)

van den Boogaard M, Pickkers P, Slooter AJ, Kuiper MA, Spronk PE, van der Voort PH, van der Hoeven JG, Donders R, van Achterberg T, Schoonhoven L. Development and validation of PRE-DELIRIC (PREdiction of DELIRium in ICu patients) delirium prediction model — View Citation

van den Boogaard M, Schoonhoven L, Maseda E, Plowright C, Jones C, Luetz A, Sackey PV, Jorens PG, Aitken LM, van Haren FM, Donders R, van der Hoeven JG, Pickkers P. Recalibration of the delirium prediction model for ICU patients (PRE-DELIRIC): a multinati — View Citation

Wassenaar A, van den Boogaard M, van Achterberg T, Slooter AJ, Kuiper MA, Hoogendoorn ME, Simons KS, Maseda E, Pinto N, Jones C, Luetz A, Schandl A, Verbrugghe W, Aitken LM, van Haren FM, Donders AR, Schoonhoven L, Pickkers P. Multinational development an — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Development of ICU delirium	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).	During the first 14 days after ICU admission
Secondary	Delirium subtype	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)	During the first 14 days after ICU admission
Secondary	Delirium duration	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).	During the first 14 days after ICU admission
Secondary	Delirium episodes	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.	During the first 14 days after ICU admission
Secondary	Delirium onset in a specified period	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)	During the first 14 days after ICU admission
Secondary	Development of delirium	Defined as = 2 positive assessments for delirium within 48 hours (because of the fluctuating course of delirium).	During the first 14 days after ICU admission