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

Delirium Clinical Trial

— DELUSION  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05841368
• Other study ID #: DELUSION-24-CZ
• Status: Not yet recruiting
• Start date: January 1, 2024
• Est. completion date: July 31, 2024

Study information

• Verified date: April 2023
• Source: Brno University Hospital
• Contact: Jozef UO Klucka, assoc.prof.MD., Ph.D.
• Phone: +420532234696
• Email: klucka.jozef[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 2000
• Est. completion date: July 31, 2024
• Est. primary completion date: July 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• duration of ICU stay shorter than 24 hours

Related Conditions & MeSH terms

• Delirium

Intervention

Diagnostic Test:
• CAM-ICU
Delirium in adult patients will be screened according to CAM-ICU
• pCAM-ICU
Delirium in adult patients will be screened according to pCAM-ICU

Locations

Country	Name	City	State
Czechia	Brno University Hospital	Brno	South Moravian Region

Sponsors (3)

Lead Sponsor	Collaborator
Brno University Hospital	Department of Neurology, University Hospital Brno, Masaryk University

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Delirium management	Management of delirium will be evaluated	during 30 days after study initiation in selected ICU
Secondary	Inhospital mortality	Inhospital mortality will be evaluated	during 30 days after study initiation in selected ICU
Secondary	28-days mortality	28-days mortality will be evaluated	after patient inclusion into the study
Secondary	90-days mortality	long term mortality will be evaluated	after patient inclusion into the study