Clinical trial NCT04218461: PREdiction of DELIRium in Medical ICU Patients
Official title: Evaluation of the Usability of the Delirium Prediction Model of PRE-DELIRIC (PREdiction of DELIRium) in Medical ICU Patients
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Intensive Care Unit Delirium
Lead sponsor: Istanbul Demiroglu Bilim University
Sponsor class: OTHER
First posted: 2020-01-06
Enrollment: 172
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Stay in the medical ICU

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Predict of delirium risk with questionnare
timeFrame: up to 20 weeks
measure: Predict of delirium risk with questionnare 2
timeFrame: up to 20 weeks
measure: Comparison of delirium risk with two questionnares
timeFrame: up to 20 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Demiroglu Bİlim University
state: Sisli
Study officials:
affiliation: Istanbul Demiroglu Bilim University
name: Nurten OZEN
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
citation: 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.