PREdiction of DELIRium in Medical ICU Patients

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04218461
• Other study ID #: 2019-08
• Status: Completed
• Start date: November 5, 2019
• Est. completion date: April 30, 2020

Study information

• Verified date: July 2020
• Source: Istanbul Demiroglu Bilim University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 172
• Est. completion date: April 30, 2020
• Est. primary completion date: April 30, 2020
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Delirium
• Intensive Care Unit Delirium

Intervention

Diagnostic Test:
• PRE-DELIRIC model
To predict delirium according to risk factors in the PRE-DELIRIC model

Locations

Country	Name	City	State
Turkey	Demiroglu BIlim University	Istanbul	Sisli

Sponsors (1)

Lead Sponsor	Collaborator
Istanbul Demiroglu Bilim University

Country where clinical trial is conducted

Turkey, 

References & Publications (3)

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. — View Citation

Sosa FA, Roberti J, Franco MT, Kleinert MM, Patrón 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. English, Portuguese. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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