External Validation of Delirium Prediction Models for Intensive Care Patients

NCT ID: NCT05084482

Last Updated: 2025-04-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 660 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-01-01
• Study Completion Date: 2023-09-30

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.

Conditions

Delirium

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Prediction models

Intervention Type: OTHER

The prediction scores are validated by the CAM-ICU scores up to 14 days after ICU admission.

Interventions

Prediction models

The prediction scores are validated by the CAM-ICU scores up to 14 days after ICU admission.

Intervention Type: OTHER

Other Intervention Names

Delirium; PRE-DELIRIC; E-PRE-DELIRIC

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 110 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Zealand University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Lone Musaeus Poulsen

Head of ICU

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Neeliya Anton Joseph, BSc Medicine

Role: PRINCIPAL_INVESTIGATOR

Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark

Locations

Zealand University Hospital, Department of Anaesthesiology

Køge, Zealand Region of Denmark, Denmark

Countries

Denmark

Other Identifiers

ZUH.01

Identifier Type: -

Identifier Source: org_study_id