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

NCT02518646 | Completed

• 1 other identifier: IC_2015-1782
• Study Type: observational
• Target: 2,500
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Delirium; Intensive care unit; Adult; Clinical prediction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Delirium subtype

  During the first 14 days after ICU admission

• Delirium duration

  During the first 14 days after ICU admission

• Delirium episodes

  During the first 14 days after ICU admission

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Radboud University Medical Center: lead

Study Sites (1)

Radboudumc

Nijmegen, Netherlands

Location

Related Publications (5)

• 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.

  PMID: 25894620 RESULT

• 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.

  PMID: 24441670 RESULT

• 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.

  PMID: 22323509 RESULT

• 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.

  PMID: 32035691 DERIVED

• 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.

  PMID: 29728150 DERIVED

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Mark van den Boogaard, PhD, RN

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Annelies Wassenaar, MSc, RN

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Peter Pickkers, PhD, MD

  Radboud University Medical Center

  PRINCIPAL INVESTIGATOR

• Lisette Schoonhoven, PhD

  University of Southampton

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 21, 2015
• First Posted: August 10, 2015
• Study Start: September 1, 2015
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 19, 2017

Record last verified: 2017-01

Data Sharing

• IPD Sharing: Will not share

Locations

NL (1)