Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations

Delirium Clinical Trial

Official title:

Delirium in the (Neuro)Intensive/Critical Care in the Adult and Paediatric Czech Populations

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05891873
• Other study ID #: DELUSION-DEEP-CZ
• Status: Recruiting
• Start date: September 7, 2023
• Est. completion date: December 2027

Study information

• Verified date: October 2023
• Source: Masaryk University
• Contact: Josef Bednarík, prof. MD, CSc.
• Phone: 532231481
• Email: bednarik.josef[@]fnbrno.cz
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Intensive and critical care in the intensive care unit (ICU) is often associated with ICU delirium and post-ICU dementia, regardless of the nature of the primary disease or insult. Optimal practical management of ICU delirium including its screening, prevention, and treatment, is an integral part of the current recommendations for optimal ICU care, but there are large gaps in the knowledge about the optimal and most effective prevention and treatment of this complication. Information on the actual implementation of these recommendations in the Czech Republic is lacking. The diagnosis of delirium is particularly challenging in neurointensive care patients (due to overlap with symptoms of primary brain lesions) and in a paediatric population. A complementary multicentre observational 4-year follow-up study, performed in an adult neurointensive/critical care stroke cohort and in a paediatric intensive/critical care cohort in centres following currently recommended preventive measures (Delusion-deep-cz) will investigate the incidence of ICU delirium and post-ICU dementia and their modifiable and non-modifiable predisposing and precipitating risk factors. Objectives are to determine the optimal methods for diagnostic screening of these complications and for the differential diagnosis of conditions mimicking delirium (non-convulsive epileptic state) or symptoms hindering its diagnosis (aphasia), and to study the association between sleep disturbances and ICU delirium to verify the role of sleep in the pathophysiology of delirium.

Description:

Design

• Multicentre observational follow-up cohort study with 2 different cohorts and a minimum follow-up period of 6 months.

Recruitment (groups)

1. Neurointensive/neurocritical group (N-ICU): patients with acute ischaemic or haemorrhagic stroke admitted to the Stroke Unit or ICU of the Department of Neurology, University Hospital Brno (NK-UHB).

2. Paediatric intensive/critical group (P-ICU): children aged 6-18 years, admitted to the Paediatric ICU - Department of Paediatric Anaesthesiology and Intensive Care (KDAR-UHB) with a stay of at least 24 hours (including postoperative care).

General working hypotheses

• Current recommendations for the practical management (PADIS) and prevention of delirium lead to a decrease in the incidence of ICU-delirium and post-ICU dementia and may also change the spectrum of significant risk factors.

• In the Czech Republic, both general knowledge and practical implementation of these recommendations may be low.

• Currently recommended screening instruments for ICU-delirium are valid and reliable in both adult and paediatric cohorts of (neuro)intensive/critical patients and can replace the expert assessment using DSM-IV or V criteria (The Diagnostic and Statistical Manual of Mental Illnesses).

• Non-convulsive status epilepticus (NCSE) may mimic ICU-delirium and a routine EEG exam in patients meeting the criteria for ICU delirium may be helpful.

• Aphasia may complicate the diagnosis of delirium and may prevent the use of the current screening tools for delirium in neurointensive care patients.

• Sleep disturbances in ICU patients are often associated with the development of ICU delirium and evaluating the time course of these conditions may reveal their possible causal relationship.

Outcomes Primary outcomes

• Development of ICU delirium Secondary outcomes

• Length of stay in ICU

• Case-fatality risk

• Post-ICU dementia (BDS, Blessed dementia scale)

• Degree of functional dependency (Barthel index)

Objectives

• To review the incidence and significant modifiable and non-modifiable predisposing and precipitating risk factors for ICU delirium and post-ICU dementia in general and neuro-intensive/critical care in adult and paediatric populations treated in health care facilities according to current recommendations for prevention of these complications (ABCDEF bundle).

• To verify optimal methods for diagnostic screening of ICU delirium: CAM-ICU (The confusion assessment method for the ICU), 4AT (Rapid clinical test for delirium detection - 4AT) and ICDSC (Intensive care delirium screening checklist) in adult populations and pCAM-ICU (paediatric confusion assessment method for the ICU), psCAM-ICU (pre-school confusion assessment method for the ICU) and CAPD (Cornell Assessment of Pediatric Delirium) in paediatric populations to screen for delirium.

• To verify optimal methods for the differential diagnosis of conditions that mimic or complicate the diagnosis of ICU delirium: NCSE, aphasia,

• To investigate associations between sleep disturbances and ICU-delirium to confirm their role in the pathophysiology of delirium.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: December 2027
• Est. primary completion date: May 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Neurointensive/neurocritical group (N-ICU): patients with acute ischaemic or haemorrhagic stroke admitted to the Stroke Unit or ICU of the Department of Neurology, University Hospital Brno (NK-UHB).

• Paediatric intensive/critical group (P-ICU): children aged 6-18 years, admitted to the Paediatric ICU - Department of Paediatric Anaesthesiology and Intensive Care (KDAR-UHB) with a stay of at least 24 hours (including postoperative care).

Exclusion Criteria:

• (N-ICU) severe trauma with short life expectancy (days)

• duration of the ICU stay shorter than 24 hours

Related Conditions & MeSH terms

• Delirium

Intervention

Diagnostic Test:
• CAM-ICU
Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.
• ICDSC
Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.
• 4AT
Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.
• p(s)CAM-ICU
Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.
• CAPD
Patients who meet the inclusion criteria will be screened daily for delirium using the screening test mentioned above.
• MASTcz (The Mississippi Aphasia Screening Test)
People with aphasia will be examined by a skilled speech therapist.
• EEG
Patients with positive delirium will undergo EEG examination. 10-min native EEG.

Locations

Country	Name	City	State
Czechia	Brno University Hospital	Brno

Sponsors (3)

Lead Sponsor	Collaborator
Masaryk University	Brno University Hospital, University Hospital, Motol

Country where clinical trial is conducted

Czechia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who develop ICU delirium	assessed by experienced neuro-intensivist	up to 14 days after admission
Secondary	Length of stay in ICU		up to 10 weeks
Secondary	Mortality		6 months
Secondary	Number of participants and severity of post-ICU dementia, cognitive impairment(Blessed dementia scale, BDS)		6 months
Secondary	Degree of functional dependency (Barthel index)	the higher score, the worse result meaning cognitive impairment and non-independence	up to 10 weeks and after 6 months