External Validation of Delirium Prediction Models for Intensive Care Patients

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

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.

Study Overview

• Status: Completed
• Conditions: Delirium
• Intervention / Treatment: Other: Prediction models

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 Type: Observational
• Enrollment (Actual): 660

Contacts and Locations

Study Locations

• Denmark
  • Zealand Region Of Denmark
    • Køge, Zealand Region Of Denmark, Denmark, 4600
      • Zealand University Hospital, Department of Anaesthesiology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 110 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All adult patients admitted to participating ICUs in the Zealand Region between November 2021 and July 2022.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adult patients admitted to Intensive Care Unit (ICU); Eligible patients are scored by E-PRE-DELIRIC at admission and PRE-DELIRIC 24 hours after admission.	Other: Prediction models; The prediction scores are validated by the CAM-ICU scores up to 14 days after ICU admission.; Other Names: Delirium; PRE-DELIRIC; E-PRE-DELIRIC

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Zealand University Hospital
• Investigators: Principal Investigator: Neeliya Anton Joseph, BSc Medicine, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2022
• Primary Completion (Actual): July 31, 2023
• Study Completion (Actual): September 30, 2023

Study Registration Dates

• First Submitted: October 6, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 19, 2021

Study Record Updates

• Last Update Posted (Actual): April 8, 2025
• Last Update Submitted That Met QC Criteria: April 4, 2025
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Keywords: ICU; Observational; Critical illness; prediction; Delirium
• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: ZUH.01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual anonymised participant data will be made available to researchers upon reasonable request after termination and publication of the study.
• IPD Sharing Time Frame: After the termination and publication of the study
• IPD Sharing Access Criteria: Reasonable request by researcher based on study protocol.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ANALYTIC_CODE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No