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Clinical Trials/NCT05084482
NCT05084482
Completed
Not Applicable

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

Zealand University Hospital1 site in 1 country660 target enrollmentJanuary 1, 2022
ConditionsDelirium

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Delirium
Sponsor
Zealand University Hospital
Enrollment
660
Locations
1
Primary Endpoint
AUROC for PRE-DELIRIC
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
January 1, 2022
End Date
September 30, 2023
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Lone Musaeus Poulsen

Head of ICU

Zealand University Hospital

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

Outcomes

Primary Outcomes

AUROC for PRE-DELIRIC

Time Frame: Duration of the study, november 2021 to september 2022

Area Under the Receiver Operating Characteristics (AUROC) for PRE-DELIRIC

AUROC for E-PRE-DELIRIC

Time Frame: Based on 14 days of ICU admission

Area Under the Receiver Operating Characteristics (AUROC) for E-PRE-DELIRIC

Secondary Outcomes

  • Hospital length of stay(30 days after ICU admission)
  • 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)

Study Sites (1)

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