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CompletedNCT04218461Updated Jul 28, 2020

PREdiction of DELIRium in Medical ICU Patients

An observational study in Delirium and Intensive Care Unit Delirium, sponsored by Istanbul Demiroglu Bilim University. Completed at 1 site in Turkey. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-07-28.

Sponsored by Istanbul Demiroglu Bilim University · Observational

Study type
Observational
Model
Other
Time perspective
Prospective
Enrollment
172
Ages
18 Years and older
Sex
All
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Study summary

In intensive care unit (ICU) patients, the ability to predict delirium may help reduce its incidence, duration, and severity. The PREdiction of DELIRium in ICU (PRE-DELIRIC) model was recently developed for this purpose. Our aim was to test the PRE-DELIRIC model in the medical ICU.

Read the detailed description

Delirium, a disturbance of consciousness with an acute onset and a variable course of impaired cognitive functioning, is common in patients admitted to the ICU. Several tools are available for assessing delirium in ICU patients, of which the confusion assessment method-intensive care unit (CAM-ICU) has the highest sensitivity and specificity.

Although several predictive models for non-intensive care patients exist, as well as one for older medical intensive care patients, no evidence based prediction model for general intensive care patients is available. Also the tools are not involved the metabolic parameters which cause delirium. Because of that the tool need to have biochemical parameters.

In the light of these information our aim is to validate the PRE-DELIRIC model in medical ICU in Turkish people.

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Conditions studied

  • Delirium
  • Intensive Care Unit Delirium

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In context

Delirium

1,057 studies on the registry are indexed under Delirium; 238 are open to participants now.

This study's enrollment of 172 is below the median of 200 across 418 observational studies indexed under Delirium.

Browse Delirium studies →

Lead sponsor

Istanbul Demiroglu Bilim University is the lead sponsor of 22 studies on the registry; 4 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Non-probability sample

Study population

Stay in the medical ICU

Inclusion criteria

  • be at the medical ICU
  • 18 and older years of age
  • predict to stay in the ICU over 24 hours
  • not to be pregnant
  • not to be breastfeeding
  • not to have dementia, alcoholism
  • have not previously received a diagnosis of delirium
  • have not communication problem
  • agree to participate to the study by patient's relatives

Exclusion criteria

Exclusion Criteria:

  • younger than 18 years old
  • stay in the ICU less than 24 hours
  • be pregnant
  • breastfeeding
  • have dementia, alcoholism
  • previously received a diagnosis of delirium
  • have communication problem
  • not agree to participate to the study by patient's relatives
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Study design

Observational model
Other
Time perspective
Prospective
Enrollment
172 participants (actual)
Patient registry
No

Interventions

  • Diagnostic testPRE-DELIRIC model

    To predict delirium according to risk factors in the PRE-DELIRIC model

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What researchers measure

Primary outcomes

  1. Predict of delirium risk with questionnare

    CAM-ICU will be used for defining the delirium risk. We define delirium as a minimum of one positive CAM-ICU screening during each patient's intensive care stay developed and validated for ICU patients, assesses 10 risk factors for delirium that are readily observable within the first 24 hours following ICU admission. CAM-ICU scale includes of four items. The items are about level of consciousness, assessment of attention, state of thought organization and following a simple command. In order to be diagnosed with delirium, the first two items and one of the third or fourth item must be in favor of delirium.

    Time frame: up to 20 weeks

  2. Predict of delirium risk with questionnare 2

    The PRE-DELIRIC model will be used for defining the delirium risk. The PRE-DELIRIC model developed and validated for ICU patients, assesses 10 risk factors for delirium that are readily observable within the first 24 hours following ICU admission. The model consists of biochemical parameters, used drugs, infection status.

    Time frame: up to 20 weeks

  3. Comparison of delirium risk with two questionnares

    The investigator will assess the CAM-ICU and PRE-DELIRIC in the first 24 hours after the patient comes to the ICU. The PRE-DELIRIC model and CAM-ICU will use for defining the deliirum risk. The investigators will do validity and reliability of PRE-DELIRIC model in medical ICU patients.

    Time frame: up to 20 weeks

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Study locations

1 site
  • Demiroglu Bİlim University
    Istanbul, Sisli 34360, Turkey
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References and documents

Publications

  • 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 ↗
  • Sosa FA, Roberti J, Franco MT, Kleinert MM, Patron AR, Osatnik J. Assessment of delirium using the PRE-DELIRIC model in an intensive care unit in Argentina. Rev Bras Ter Intensiva. 2018 Mar;30(1):50-56. doi: 10.5935/0103-507x.20180010. PubMed 29742219 ↗
  • Green C, Bonavia W, Toh C, Tiruvoipati R. Prediction of ICU Delirium: Validation of Current Delirium Predictive Models in Routine Clinical Practice. Crit Care Med. 2019 Mar;47(3):428-435. doi: 10.1097/CCM.0000000000003577. PubMed 30507844 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 28, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT04218461
Lead sponsor
Istanbul Demiroglu Bilim University
Responsible party
Nurten Ozen (Assistant Professor, Istanbul Demiroglu Bilim University) — Principal investigator
First posted
Jan 6, 2020
Start date
Nov 5, 2019
Primary completion
Apr 30, 2020
Completion
Apr 30, 2020
Last update
Jul 28, 2020

Study contacts

Nurten OZEN
principal investigator · Istanbul Demiroglu Bilim University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.

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