External Validation of Delirium Prediction Models for Intensive Care Patients

Delirium Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05084482
• Other study ID #: ZUH.01
• Status: Recruiting
• Start date: January 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: January 2023
• Source: Zealand University Hospital
• Contact: Neeliya Anton Joseph, BSc medicine
• Phone: 61700254
• Email: neea[@]regionsjaelland.dk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 660
• Est. completion date: September 30, 2023
• Est. primary completion date: July 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 110 Years

Eligibility

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

Related Conditions & MeSH terms

• Delirium

Intervention

Other:
• Prediction models
The prediction scores are validated by the CAM-ICU scores up to 14 days after ICU admission.

Locations

Country	Name	City	State
Denmark	Zealand University Hospital, Department of Anaesthesiology	Køge	Zealand Region Of Denmark

Sponsors (1)

Lead Sponsor	Collaborator
Zealand University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	AUROC for PRE-DELIRIC	Area Under the Receiver Operating Characteristics (AUROC) for PRE-DELIRIC	Duration of the study, november 2021 to september 2022
Primary	AUROC for E-PRE-DELIRIC	Area Under the Receiver Operating Characteristics (AUROC) for E-PRE-DELIRIC	Based on 14 days of ICU admission
Secondary	30-days mortality	Dead or alive at day 30 after ICU admission	30 days efter ICU admission
Secondary	Time on ventilator	Days in need of mechanical ventilation up to 14 days of ICU admission	14 days after ICU admission
Secondary	ICU length of stay	Days in the ICU up to 30 days	30 days after ICU admission
Secondary	Hospital length of stay	Days in the hospital up to 30 days after ICU admission	30 days after ICU admission