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DeliriumDECISIONNCT02518646

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

An observational study of Delirium, run by Radboud University Medical Center at 1 site in Netherlands.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Delirium
How many people
2,500 participants
Where
1 siteNetherlands
Study dates
Sep 2015to Dec 2016
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

Netherlands1 site

  • Radboudumc

    Nijmegen

Other trials in Netherlands

About this study

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.

Read the 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.

Conditions
Delirium
Keywords
Delirium, Intensive care unit, Adult, Clinical prediction
Medical subject headings
Delirium

What is being measured

The primary outcome is the main question the study is designed to answer.

  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).

    Measured: During the first 14 days after ICU admission

Secondary outcomes (5)

  1. 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)

    Measured: During the first 14 days after ICU admission

  2. 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).

    Measured: During the first 14 days after ICU admission

  3. 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.

    Measured: During the first 14 days after ICU admission

  4. 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)

    Measured: During the first 14 days after ICU admission

  5. Development of delirium

    Defined as ≥ 2 positive assessments for delirium within 48 hours (because of the fluctuating course of delirium).

    Measured: During the first 14 days after ICU admission

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2015 (estimated)
  2. Study startSep 2015
  3. Primary completionDec 2016
  4. Study completionDec 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
2,500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02518646
Sponsor's protocol ID
IC_2015-1782
Acronym
DECISION
Status last verified
Jan 2017
First submitted
21 Jul 2015
Last updated
19 May 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • 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.

    PubMed 25894620

  • 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.

    PubMed 24441670

  • 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.

    PubMed 22323509

  • 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.

    PubMed 32035691

  • 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.

    PubMed 29728150

Questions about this trial

What is this clinical trial studying?

An observational study of Delirium, run by Radboud University Medical Center at 1 site in Netherlands.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Development of ICU delirium (time frame: During the first 14 days after ICU admission). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02518646, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2017.

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