External Validation of Delirium Prediction Models for Intensive Care Patients

Study Overview
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Brief Summary
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Delirium is frequently observed among critically ill patients and is associated with detrimental outcomes. Currently, no evidence-based prevention or treatment exists for delirium, and especially, the inability to identify effective preventive measures of delirium has increased the focus on identifying patients with a high risk of delirium through prediction models. Two prediction models have been developed to estimate the risk of delirium in ICU patients: the prediction model for delirium (PRE-DELIRIC) and the early prediction model for delirium (E-PRE-DELIRIC). These robust and well-calibrated prediction models have the potential of assisting in identifying patients with the highest risk for delirium and thereby to focusing preventive strategies on the most vulnerable group. However further validation is needed in a Danish population.

Detailed Description
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Adult ICU patients admitted to the participating ICUs in the Region Zealand are included according to eligibility. Eligible patients will be assessed with E-PREDELIRIC at admission to the ICU and PREDELIRIC 24h after admission to the ICU. Patients will be screened twice daily with CAM-ICU until ICU discharge, death, transferal to non-participating ICU or for a maximum observation period of 14 days. Central screening via EPIC PDM and registration in central database (REDCap, ZUH) by the principal investigator. The following are registered: Age, sex, history of cognitive impairment, history of alcohol abuse, admission category, urgent admission, mean arterial blood pressure at the time of ICU admission, use of corticosteroids, respiratory failure, Blood Urea Nitrogen/Carbamide, APACHE-II score, administered morphine does, use of sedatives, metabolic acidosis, coma, presence of infection, delirium status by CAM-ICU, time of ventilation, length of ICU and hospital stay, mortality.

Official Title
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External Validation of Delirium Prediction Models for Intensive Care Patients. A Prospective, Multicenter, Cohort Study

Conditions
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Delirium

Intervention / Treatment
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* Other: Prediction models


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Acute admission to an ICU AND Age > 18 of years Exclusion Criteria: Total admittance to the ICU less than 24 hours Delirium assessment nonapplicable (hearing or visual disabilities, language barriers, or mentally incompetent

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 110 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Adult patients admitted to Intensive Care Unit (ICU)<br>Eligible patients are scored by E-PRE-DELIRIC at admission and PRE-DELIRIC 24 hours after admission. | Other: Prediction models<br>* The prediction scores are validated by the CAM-ICU scores up to 14 days after ICU admission.<br>* Other names: E-PRE-DELIRIC;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUROC for PRE-DELIRIC | Area Under the Receiver Operating Characteristics (AUROC) for PRE-DELIRIC | Duration of the study, november 2021 to september 2022 | 
| AUROC for E-PRE-DELIRIC | Area Under the Receiver Operating Characteristics (AUROC) for E-PRE-DELIRIC | Based on 14 days of ICU admission | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 30-days mortality | Dead or alive at day 30 after ICU admission | 30 days efter ICU admission | 
| Time on ventilator | Days in need of mechanical ventilation up to 14 days of ICU admission | 14 days after ICU admission | 
| ICU length of stay | Days in the ICU up to 30 days | 30 days after ICU admission | 
| Hospital length of stay | Days in the hospital up to 30 days after ICU admission | 30 days after ICU admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Critical illness, ICU, Delirium, prediction, Observational