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DELUSION: DELIRIUM SCREENING, INCIDENCE AND MANAGEMENT OBSERVATIONAL STUDY IN 2024 - THE CZECH REPUBLIC

Sponsor
Brno University Hospital (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05841368
Collaborator
Masaryk University (Other), Department of Neurology, University Hospital Brno (Other)
2,000
Enrollment
1
Location
7
Anticipated Duration (Months)
287.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Delirium in intensive care unit (ICU) settings is a frequent complication with reported prevalence of 31%. Recent data has revealed the connection between delirium and increased 30days mortality after hospital release and the higher incidence of readmission to emergency. Despite the high prevalence and well described validation methods for screening, the precise incidence remains unclear due to insufficient screening in ICU settings. The incidence of delirium in Czech Republic remains undescribed, beside data reported from neurointensive care patients and single-center general critically ill patients data.

Condition or Disease Intervention/Treatment Phase
  • Diagnostic Test: CAM-ICU
  • Diagnostic Test: pCAM-ICU

Detailed Description

All patients fulfilling inclusion criteria in intensive care settings in involved ICUs in Czech Republic will be included into the study. Data will be recorded for 1 consequent month. Basic demography will be evaluated. In each patient standard delirium screening based on the institutional ICU rules will be performed. If no screening method were set,Confusion Assessment Method - CAM-ICU for adult and pediatric Confusion Assessment Method -pCAM-ICU for pediatric patients would be used together with delirium management, restrain procedures, sedative/neuroleptics administration, 28-days mortality. All data will be recorded into to predefined eCRF.

Study Design

Study Type:
Observational
Anticipated Enrollment :
2000 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
DELIRIUM SCREENING, INCIDENCE AND MANAGEMENT OBSERVATIONAL STUDY IN 2024 - THE CZECH REPUBLIC
Anticipated Study Start Date :
Jan 1, 2024
Anticipated Primary Completion Date :
Jul 31, 2024
Anticipated Study Completion Date :
Jul 31, 2024

Arms and Interventions

Arm Intervention/Treatment
Adult ICU patients

Adult patients in ICU setting

Diagnostic Test: CAM-ICU
Delirium in adult patients will be screened according to CAM-ICU
Other Names:
  • delirium screening

    		•
    Pediatric ICU patients

    Pediatric patients in ICU setting

    Diagnostic Test: pCAM-ICU
    Delirium in adult patients will be screened according to pCAM-ICU
    Other Names:
  • delirium screening

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Delirium prevalence [during 30 days after study initiation in selected ICU]

      Delirium prevalence by CAM-ICU and pCAM-ICU will be screened in defined time interval

    Secondary Outcome Measures

    1. Delirium management [during 30 days after study initiation in selected ICU]

      Management of delirium will be evaluated

    2. Inhospital mortality [during 30 days after study initiation in selected ICU]

      Inhospital mortality will be evaluated

    3. 28-days mortality [after patient inclusion into the study]

      28-days mortality will be evaluated

    4. 90-days mortality [after patient inclusion into the study]

      long term mortality will be evaluated

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • Patients in ICU settings

    • in defined time interval of the study

    Exclusion Criteria:
    • duration of ICU stay shorter than 24 hours

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Brno University Hospital Brno South Moravian Region Czechia 62500

    Sponsors and Collaborators

    • Brno University Hospital
    • Masaryk University
    • Department of Neurology, University Hospital Brno

    Investigators

    • Study Chair: Petr Stourac, prof. MD., Ph.D., MBA, Department of paediatric anaesthesia and intensive care medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Petr Štourač, MD, Clinical Professor, Brno University Hospital
    ClinicalTrials.gov Identifier:
    NCT05841368
    Other Study ID Numbers:
    • DELUSION-24-CZ
    First Posted:
    May 3, 2023
    Last Update Posted:
    May 3, 2023
    Last Verified:
    Apr 1, 2023
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Petr Štourač, MD, Clinical Professor, Brno University Hospital
    Delirium
    Screening
    Therapy
    CAM-ICU
    Additional relevant MeSH terms:
    Delirium

    Study Results

    No Results Posted as of May 3, 2023