Clinical trial NCT02518646: DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models
Official title: DElirium prediCtIon in the intenSIve Care Unit: Head to Head comparisON of Two Delirium Prediction Models
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Delirium
Intensive care unit
Adult
Clinical prediction
Lead sponsor: Radboud University Medical Center
Sponsor class: OTHER
First posted: 2015-08-10
Enrollment: 2500
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

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.

Primary outcomes:
measure: Development of ICU delirium
timeFrame: During the first 14 days after ICU admission
Secondary outcomes:
measure: Delirium subtype
timeFrame: During the first 14 days after ICU admission
measure: Delirium duration
timeFrame: During the first 14 days after ICU admission
measure: Delirium episodes
timeFrame: During the first 14 days after ICU admission
measure: Delirium onset in a specified period
timeFrame: During the first 14 days after ICU admission
measure: Development of delirium
timeFrame: During the first 14 days after ICU admission
Other outcomes:
Locations:
city: Nijmegen
country: Netherlands
facility: Radboudumc
Study officials:
affiliation: Radboud University Medical Center
name: Mark van den Boogaard, PhD, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Annelies Wassenaar, MSc, RN
role: PRINCIPAL_INVESTIGATOR
affiliation: Radboud University Medical Center
name: Peter Pickkers, PhD, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Southampton
name: Lisette Schoonhoven, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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 and validation of an early prediction model for delirium in ICU patients. Intensive Care Med. 2015 Jun;41(6):1048-56. doi: 10.1007/s00134-015-3777-2. Epub 2015 Apr 18.
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 multinational observational study. Intensive Care Med. 2014 Mar;40(3):361-9. doi: 10.1007/s00134-013-3202-7. Epub 2014 Jan 18.
citation: 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 for intensive care patients: observational multicentre study. BMJ. 2012 Feb 9;344:e420. doi: 10.1136/bmj.e420.
citation: van den Boogaard M, Wassenaar A, van Haren FMP, Slooter AJC, Jorens PG, van der Jagt M, Simons KS, Egerod I, Burry LD, Beishuizen A, Pickkers P, Devlin JW. Influence of sedation on delirium recognition in critically ill patients: A multinational cohort study. Aust Crit Care. 2020 Sep;33(5):420-425. doi: 10.1016/j.aucc.2019.12.002. Epub 2020 Feb 5.
citation: Wassenaar A, Schoonhoven L, Devlin JW, van Haren FMP, Slooter AJC, Jorens PG, van der Jagt M, Simons KS, Egerod I, Burry LD, Beishuizen A, Matos J, Donders ART, Pickkers P, van den Boogaard M. Delirium prediction in the intensive care unit: comparison of two delirium prediction models. Crit Care. 2018 May 5;22(1):114. doi: 10.1186/s13054-018-2037-6.