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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05084482
Enrollment
660
Registered
2021-10-19
Start date
2022-01-01
Completion date
2023-09-30
Last updated
2025-04-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Delirium

Keywords

Critical illness, ICU, Delirium, prediction, Observational

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.

Interventions

OTHERPrediction models

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

Sponsors

Zealand University Hospital
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 110 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
AUROC for PRE-DELIRICDuration of the study, november 2021 to september 2022Area Under the Receiver Operating Characteristics (AUROC) for PRE-DELIRIC
AUROC for E-PRE-DELIRICBased on 14 days of ICU admissionArea Under the Receiver Operating Characteristics (AUROC) for E-PRE-DELIRIC

Secondary

MeasureTime frameDescription
30-days mortality30 days efter ICU admissionDead or alive at day 30 after ICU admission
Time on ventilator14 days after ICU admissionDays in need of mechanical ventilation up to 14 days of ICU admission
ICU length of stay30 days after ICU admissionDays in the ICU up to 30 days
Hospital length of stay30 days after ICU admissionDays in the hospital up to 30 days after ICU admission

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026