PREdiction of DELIRium in Medical ICU Patients

NCT ID: NCT04218461

Last Updated: 2020-07-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

172 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-11-05

Study Completion Date

2020-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Delirium Intensive Care Unit Delirium

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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PRE-DELIRIC model

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Istanbul Demiroglu Bilim University

OTHER

Sponsor Role lead

Responsible Party

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Nurten Ozen

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Nurten OZEN

Role: PRINCIPAL_INVESTIGATOR

Istanbul Demiroglu Bilim University

Locations

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Demiroglu Bİlim University

Istanbul, Sisli, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 22323509 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29742219 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30507844 (View on PubMed)

Other Identifiers

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2019-08

Identifier Type: -

Identifier Source: org_study_id

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