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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Delirium
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 2000

Contacts and Locations

• Study Contact: Name: Jozef UO Klučka, assoc.prof.MD., Ph.D.; Phone Number: +420532234696; Email: klucka.jozef@fnbrno.cz
• Study Contact Backup: Name: Jan Malaska, MD.PHD. EDIC; Phone Number: +420532234695; Email: malaska.jan@fnbrno.cz

Study Locations

• Czechia
  • South Moravian Region
    • Brno, South Moravian Region, Czechia, 62500
      • Brno University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ICU patients

Description

Inclusion Criteria:

• Patients in ICU settings
• in defined time interval of the study

Exclusion Criteria:

• duration of ICU stay shorter than 24 hours

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium prevalence	Delirium prevalence by CAM-ICU and pCAM-ICU will be screened in defined time interval	during 30 days after study initiation in selected ICU

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Delirium management	Management of delirium will be evaluated	during 30 days after study initiation in selected ICU
Inhospital mortality	Inhospital mortality will be evaluated	during 30 days after study initiation in selected ICU
28-days mortality	28-days mortality will be evaluated	after patient inclusion into the study
90-days mortality	long term mortality will be evaluated	after patient inclusion into the study

Collaborators and Investigators

• Sponsor: Brno University Hospital
• Collaborators: Masaryk University; Department of Neurology, University Hospital Brno

Study record dates

Study Major Dates

• Study Start (Anticipated): January 1, 2024
• Primary Completion (Anticipated): July 31, 2024
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: April 22, 2023
• First Submitted That Met QC Criteria: April 22, 2023
• First Posted (Actual): May 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 3, 2023
• Last Update Submitted That Met QC Criteria: April 22, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: Screening; Therapy; Delirium; CAM-ICU
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Confusion; Neurobehavioral Manifestations; Neurocognitive Disorders; Delirium
• Other Study ID Numbers: DELUSION-24-CZ

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No