PREdiction of DELIRium in Medical ICU Patients

Completed

• Conditions: Intensive Care Unit Delirium; Delirium

• Registration Number: NCT04218461
• Lead Sponsor: Istanbul Demiroglu Bilim University

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.

Study Timeline

• Study Start: 2019-11-05
• Study First Submitted: 2019-12-30
• Study First Submitted QC: 2020-01-02
• Study First Posted: 2020-01-06
• Primary Completion: 2020-04-30
• Study Completion: 2020-04-30
• Status Verified: 2020-07
• Last Update Submitted: 2020-07-27
• Last Update Posted: 2020-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 172

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Predict of delirium risk with questionnare	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	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	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.

Trial Locations

Locations (1)

Demiroglu Bİlim University; 🇹🇷 Istanbul, Sisli, Turkey