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Clinical Trials/NCT04218461
NCT04218461
Completed
Not Applicable

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

Istanbul Demiroglu Bilim University1 site in 1 country172 target enrollmentNovember 5, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Istanbul Demiroglu Bilim University
Enrollment
172
Locations
1
Primary Endpoint
Predict of delirium risk with questionnare
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
November 5, 2019
End Date
April 30, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Istanbul Demiroglu Bilim University
Responsible Party
Principal Investigator
Principal Investigator

Nurten Ozen

Assistant Professor

Istanbul Demiroglu Bilim University

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

Outcomes

Primary Outcomes

Predict of delirium risk with questionnare

Time Frame: up to 20 weeks

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.

Predict of delirium risk with questionnare 2

Time Frame: up to 20 weeks

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.

Comparison of delirium risk with two questionnares

Time Frame: up to 20 weeks

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.

Study Sites (1)

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