External Validation of Delirium Prediction Models for Intensive Care Patients

Sponsor
Zealand University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05084482
Collaborator
(none)
660
1
10.9
60.3

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Prediction models

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.

Study Design

Study Type:
Observational
Anticipated Enrollment :
660 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
External Validation of Delirium Prediction Models for Intensive Care Patients. A Prospective, Multicenter, Cohort Study
Anticipated Study Start Date :
Nov 1, 2021
Anticipated Primary Completion Date :
Jul 31, 2022
Anticipated Study Completion Date :
Sep 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Adult patients admitted to Intensive Care Unit (ICU)

Eligible patients are scored by E-PRE-DELIRIC at admission and PRE-DELIRIC 24 hours after admission.

Other: Prediction models
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
  • Outcome Measures

    Primary Outcome Measures

    1. AUROC for PRE-DELIRIC [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 [Based on 14 days of ICU admission]

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

    Secondary Outcome Measures

    1. 30-days mortality [30 days efter ICU admission]

      Dead or alive at day 30 after ICU admission

    2. Time on ventilator [14 days after ICU admission]

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

    3. ICU length of stay [30 days after ICU admission]

      Days in the ICU up to 30 days

    4. Hospital length of stay [30 days after ICU admission]

      Days in the hospital up to 30 days after ICU admission

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 110 Years
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Zealand University Hospital, Department of Anaesthesiology Køge Zealand Region Of Denmark Denmark 4600

    Sponsors and Collaborators

    • Zealand University Hospital

    Investigators

    • Principal Investigator: Neeliya Anton Joseph, BSc Medicine, Department of Anaesthesiology, Zealand University Hospital, Køge, Denmark

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Lone Musaeus Poulsen, Head of ICU, Zealand University Hospital
    ClinicalTrials.gov Identifier:
    NCT05084482
    Other Study ID Numbers:
    • ZUH.01
    First Posted:
    Oct 19, 2021
    Last Update Posted:
    Oct 19, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Lone Musaeus Poulsen, Head of ICU, Zealand University Hospital
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Oct 19, 2021