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

NCT05841368 | Unknown

• 1 other identifier: DELUSION-24-CZ
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Delirium

Keywords

Delirium; Screening; Therapy; CAM-ICU

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Delirium management

  during 30 days after study initiation in selected ICU

• Inhospital mortality

  during 30 days after study initiation in selected ICU

• 28-days mortality

  after patient inclusion into the study

• 90-days mortality

  after patient inclusion into the study

Study Arms (2)

Adult ICU patients

Adult patients in ICU setting

Diagnostic Test: CAM-ICU

Pediatric ICU patients

Pediatric patients in ICU setting

Diagnostic Test: pCAM-ICU

Interventions

CAM-ICU DIAGNOSTIC_TEST

Delirium in adult patients will be screened according to CAM-ICU

Also known as: delirium screening

Adult ICU patients

pCAM-ICU DIAGNOSTIC_TEST

Delirium in adult patients will be screened according to pCAM-ICU

Also known as: delirium screening

Pediatric ICU patients

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

ICU patients

You may qualify if:

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

You may not qualify if:

• duration of ICU stay shorter than 24 hours

Sponsors & Collaborators

• Brno University Hospital: lead
• Masaryk University: collaborator
• Department of Neurology, University Hospital Brno: collaborator

Study Sites (1)

Brno University Hospital

Brno, South Moravian, 62500, Czechia

Location

MeSH Terms

Conditions

Delirium

Condition Hierarchy (Ancestors)

Confusion; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neurocognitive Disorders; Mental Disorders

Study Officials

• Petr Stourac, prof. MD., Ph.D., MBA

  Department of paediatric anaesthesia and intensive care medicine

  STUDY CHAIR

Central Study Contacts

Jozef UO Klučka, assoc.prof.MD., Ph.D.

CONTACT

+420532234696; klucka.jozef@fnbrno.cz

Jan Malaska, MD.PHD. EDIC

CONTACT

+420532234695; malaska.jan@fnbrno.cz

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Study Record Dates

• First Submitted: April 22, 2023
• First Posted: May 3, 2023
• Study Start: January 1, 2024
• Primary Completion: July 31, 2024
• Study Completion: July 31, 2024
• Last Updated: May 3, 2023

Record last verified: 2023-04

Locations

CZ (1)