PREdiction of DELIRium in Medical ICU Patients

Evaluation of the Usability of the Delirium Prediction Model of PRE-DELIRIC (PREdiction of DELIRium) in Medical ICU Patients

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.

Study Overview

• Status: Completed
• Conditions: Delirium; Intensive Care Unit Delirium
• Intervention / Treatment: Diagnostic test: PRE-DELIRIC model

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.

• Study Type: Observational
• Enrollment (Actual): 172

Contacts and Locations

Study Locations

• Turkey
  • Sisli
    • Istanbul, Sisli, Turkey, 34360
      • Demiroglu Bilim University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Stay in the medical ICU

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Other
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	up to 20 weeks
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.	up to 20 weeks
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.	up to 20 weeks

Collaborators and Investigators

• Sponsor: Istanbul Demiroglu Bilim University
• Investigators: Principal Investigator: Nurten OZEN, Istanbul Demiroglu Bilim University

Publications and helpful links

General 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): November 5, 2019
• Primary Completion (Actual): April 30, 2020
• Study Completion (Actual): April 30, 2020

Study Registration Dates

• First Submitted: December 30, 2019
• First Submitted That Met QC Criteria: January 2, 2020
• First Posted (Actual): January 6, 2020

Study Record Updates

• Last Update Posted (Actual): July 28, 2020
• Last Update Submitted That Met QC Criteria: July 27, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: 2019-08 (Other Identifier: Assistance Publique Hopitaux de Marseille)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No