PREdiction of DELIRium in Medical ICU Patients

NCT04218461 | Completed

• 1 other identifier: 2019-08
• Study Type: observational
• Target: 172
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Delirium; Intensive Care Unit Delirium

Outcome Measures

Primary Outcomes (3)

• 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

Interventions

PRE-DELIRIC model DIAGNOSTIC_TEST

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stay in the medical ICU

You may qualify if:

• be at the medical ICU
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Istanbul Demiroglu Bilim University: lead

Study Sites (1)

Demiroglu Bİlim University

Istanbul, Sisli, 34360, Turkey (Türkiye)

Location

Related Publications (3)

• 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 BACKGROUND

• 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.

  PMID: 29742219 BACKGROUND

• 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.

  PMID: 30507844 BACKGROUND

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

• Nurten OZEN

  Istanbul Demiroglu Bilim University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: December 30, 2019
• First Posted: January 6, 2020
• Study Start: November 5, 2019
• Primary Completion: April 30, 2020
• Study Completion: April 30, 2020
• Last Updated: July 28, 2020

Record last verified: 2020-07

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)