Neurological Blood-based Biomarkers and Cognitive Disorders in Critically Ill Survivors.

Intensive Care Unit Syndrome Clinical Trial

— COGNISI  

Official title:

The Relationship Between Neurological Blood-based Biomarkers and Mid-term Cognitive Disorders in Critically Ill Survivors.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05953311
• Other study ID #: COGNISI
• Status: Recruiting
• Start date: June 23, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: June 2023
• Source: University of Liege
• Contact: Anne-Françoise Rousseau, MD, PhD
• Phone: +3243234776
• Email: afrousseau[@]chuliege.be
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Cognitive disorders are common after intensive care. Currently, their diagnosis is based on clinical tests. The investigators plan to study the relationship between different neurological blood biomarkers (cytokines, S100β protein, neuron specific enolase, total Tau protein and neurofilament light chain) and the occurrence of cognitive disorders during the three months following intensive care discharge.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: December 31, 2025
• Est. primary completion date: June 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

• Anticipated ICU stay of at least 7 days for sepsis, acute respiratory distress syndrome, severe burns
• French speaking

Exclusion Criteria:

• hearing loss or blindness
• mental retardation
• known cognitive disorders or dementia
• ICU admission for neurological disease
• refusal

Related Conditions & MeSH terms

• Cognition Disorders
• Cognitive Disorder
• Cognitive Dysfunction
• Intensive Care Unit Syndrome
• Post-intensive Care Syndrome
• Syndrome

Intervention

Other:
• Blood analysis
Blood analysis for neurological biomarkers measurements
• Cognitive tests
Questionnaires assessing cognitive function

Locations

Country	Name	City	State
Belgium	University Hospital of Liège	Liège

Sponsors (1)

Lead Sponsor	Collaborator
University of Liege

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood neurological biomarkers levels	Measurement of blood levels of S100ß protein	ICU Admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of S100ß protein	day 3 after ICU admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of S100ß protein	day 7 after ICU admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of S100ß protein	day 14 after ICU admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of S100ß protein	3 months after ICU discharge
Primary	Blood neurological biomarkers levels	Measurement of blood levels of neuron specific enolase	ICU Admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of neuron specific enolase	day 3 after ICU admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of neuron specific enolase	day 7 after ICU admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of neuron specific enolase	day 14 after ICU admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of neuron specific enolase	3 months after ICU discharge
Primary	Blood neurological biomarkers levels	Measurement of blood levels of total Tau protein	ICU Admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of total Tau protein	day 3 after ICU admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of total Tau protein	day 7 after ICU admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of total Tau protein	day 14 after ICU admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of total Tau protein	3 months after ICU discharge
Primary	Blood neurological biomarkers levels	Measurement of blood levels of neurofilament light chain	ICU Admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of neurofilament light chain	day 3 after ICU admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of neurofilament light chain	day 7 after ICU admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of neurofilament light chain	day 14 after ICU admission
Primary	Blood neurological biomarkers levels	Measurement of blood levels of neurofilament light chain	3 months after ICU discharge
Primary	Cognitive disorders assessment (global assessment)	Administration of the MOCA questionnaire (Montreal Cognitive Assessment) : scoring from 0 to 30, the highest score meaning the better cognitive outcome)	the day after ICU discharge
Primary	Cognitive disorders assessment (global assessment)	Administration of the MOCA questionnaire (Montreal Cognitive Assessment) : scoring from 0 to 30, the highest score meaning the better cognitive outcome)	3 months after ICU discharge
Primary	Memory disorder assessment	Administration of the California Verbal Learning Test: a Z-score will be used to score this item	3 months after ICU discharge
Primary	Memory disorder assessment	Administration of the Brief Visuospatial Memory Test (a Z-score will be used to score this item)	3 months after ICU discharge
Primary	Speed of information processing assessment	Administration of the Ways IV test (a Z-score will be used to score this item)	3 months after ICU discharge
Primary	Executive function assessment	Administration of the Trail Making Test (a Z-score will be used to score this item)	3 months after ICU discharge
Primary	Memory disorder assessment	Administration of the Reading Span (working memory) test (a Z-score will be used to score this item)	3 months after ICU discharge
Primary	Executive function assessment	Administration of the Stroop Color and Word Test (a Z-score will be used to score this item)	3 months after ICU discharge
Primary	Executive function assessment	Administration of the Go/No-go test (a Z-score will be used to score this item)	3 months after ICU discharge