Clinical trial NCT05084482: External Validation of Delirium Prediction Models for Intensive Care Patients
Official title: External Validation of Delirium Prediction Models for Intensive Care Patients. A Prospective, Multicenter, Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Delirium
Keywords: Critical illness
ICU
Delirium
prediction
Observational
Lead sponsor: Zealand University Hospital
Sponsor class: OTHER
First posted: 2021-10-19
Enrollment: 660
Sex: ALL
Minimum age (years): 18
Maximum age (years): 110
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All adult patients admitted to participating ICUs in the Zealand Region between November 2021 and July 2022.

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.

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

Primary outcomes:
measure: AUROC for PRE-DELIRIC
timeFrame: Duration of the study, november 2021 to september 2022
measure: AUROC for E-PRE-DELIRIC
timeFrame: Based on 14 days of ICU admission
Secondary outcomes:
measure: 30-days mortality
timeFrame: 30 days efter ICU admission
measure: Time on ventilator
timeFrame: 14 days after ICU admission
measure: ICU length of stay
timeFrame: 30 days after ICU admission
measure: Hospital length of stay
timeFrame: 30 days after ICU admission
Other outcomes:
Locations:
city: Køge
country: Denmark
facility: Zealand University Hospital, Department of Anaesthesiology
state: Zealand Region Of Denmark
Study officials:
affiliation: Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark
name: Neeliya Anton Joseph, BSc Medicine
role: PRINCIPAL_INVESTIGATOR
References: