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Completed

NCT Number: NCT05084482

External Validation of Delirium Prediction Models for Intensive Care Patients

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.

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Key information

Conditions

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

Age range

18 year–110 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Zealand University Hospital, Department of Anaesthesiology

Køge, Zealand Region of Denmark, 4600, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Prediction models

Other

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

Other names: Delirium, PRE-DELIRIC, E-PRE-DELIRIC

Primary outcomes

  1. 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

  2. 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

  1. 30-days mortality

    Time frame: 30 days efter ICU admission

    Dead or alive at day 30 after ICU admission

  2. Time on ventilator

    Time frame: 14 days after ICU admission

    Days in need of mechanical ventilation up to 14 days of ICU admission

  3. ICU length of stay

    Time frame: 30 days after ICU admission

    Days in the ICU up to 30 days

  4. Hospital length of stay

    Time frame: 30 days after ICU admission

    Days in the hospital up to 30 days after ICU admission

Sponsors and collaborators

Lead sponsor

Zealand University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Oct 19, 2021
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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