External Validation of Delirium Prediction Models for Intensive Care Patients

Completed

• Conditions: Delirium
• Interventions: Other: Prediction models

• Registration Number: NCT05084482
• Lead Sponsor: Zealand University Hospital

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-10-06
• Study First Submitted QC: 2021-10-06
• Study First Posted: 2021-10-19
• Study Start: 2022-01-01
• Status Verified: 2023-01
• Primary Completion: 2023-07-31
• Study Completion: 2023-09-30
• Last Update Submitted: 2025-04-04
• Last Update Posted: 2025-04-08

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 660

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult patients admitted to Intensive Care Unit (ICU)	Prediction models	Eligible patients are scored by E-PRE-DELIRIC at admission and PRE-DELIRIC 24 hours after admission.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zealand University Hospital, Department of Anaesthesiology; 🇩🇰 Køge, Zealand Region Of Denmark, Denmark