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

Recruiting

• Conditions: Cognitive Disorder; Intensive Care Unit Syndrome; Post-intensive Care Syndrome
• Interventions: Other: Blood analysis; Other: Cognitive tests

• Registration Number: NCT05953311
• Lead Sponsor: University of Liege

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-06
• Study Start: 2023-06-23
• Study First Submitted: 2023-06-29
• Study First Submitted QC: 2023-07-11
• Last Update Submitted: 2023-07-11
• Study First Posted: 2023-07-20
• Last Update Posted: 2023-07-20
• Primary Completion: 2025-06-30
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
ICU survivors	Cognitive tests	Cohort of patients who survive an ICU stay of at least 7 days
ICU survivors	Blood analysis	Cohort of patients who survive an ICU stay of at least 7 days

Primary Outcome Measures

Name	Time	Method
Blood neurological biomarkers levels	3 months after ICU discharge	Measurement of blood levels of neurofilament light chain
Speed of information processing assessment	3 months after ICU discharge	Administration of the Ways IV test (a Z-score will be used to score this item)
Cognitive disorders assessment (global assessment)	3 months after ICU discharge	Administration of the MOCA questionnaire (Montreal Cognitive Assessment) : scoring from 0 to 30, the highest score meaning the better cognitive outcome)
Executive function assessment	3 months after ICU discharge	Administration of the Go/No-go test (a Z-score will be used to score this item)
Memory disorder assessment	3 months after ICU discharge	Administration of the Reading Span (working memory) test (a Z-score will be used to score this item)

Trial Locations

Locations (1)

University Hospital of Liège; 🇧🇪 Liège, Belgium