External Validation of Delirium Prediction Models for Intensive Care Patients

NCT05084482 | Completed

• 1 other identifier: ZUH.01
• Study Type: observational
• Target: 660
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Critical illness; ICU; Delirium; prediction; Observational

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (4)

• 30-days mortality

  30 days efter ICU admission

• Time on ventilator

  14 days after ICU admission

• ICU length of stay

  30 days after ICU admission

• Hospital length of stay

  30 days after ICU admission

Study Arms (1)

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

Interventions

Prediction models OTHER

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

Also known as: Delirium, PRE-DELIRIC, E-PRE-DELIRIC

Adult patients admitted to Intensive Care Unit (ICU)

Eligibility Criteria

• Age: 18 Years - 110 Years
• Gender Eligibility Details: Male or female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• Acute admission to an ICU AND
• Age \> 18 of years

You may not qualify if:

• Total admittance to the ICU less than 24 hours
• Delirium assessment nonapplicable (hearing or visual disabilities, language barriers, or mentally incompetent

Sponsors & Collaborators

• Zealand University Hospital: lead

Study Sites (1)

Zealand University Hospital, Department of Anaesthesiology

Køge, Zealand Region of Denmark, 4600, Denmark

Location

MeSH Terms

Conditions

Delirium; Critical Illness

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders; Disease Attributes; Pathologic Processes

Study Officials

• Neeliya Anton Joseph, BSc Medicine

  Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of ICU

Study Record Dates

• First Submitted: October 6, 2021
• First Posted: October 19, 2021
• Study Start: January 1, 2022
• Primary Completion: July 31, 2023
• Study Completion: September 30, 2023
• Last Updated: April 8, 2025

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: After the termination and publication of the study
• Access Criteria: Reasonable request by researcher based on study protocol.

Locations

DK (1)