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Clinical Trials/NCT05953311
NCT05953311
Recruiting
Not Applicable

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

University of Liege1 site in 1 country30 target enrollmentJune 23, 2023

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Intensive Care Unit Syndrome
Sponsor
University of Liege
Enrollment
30
Locations
1
Primary Endpoint
Speed of information processing assessment
Status
Recruiting
Last Updated
2 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
June 23, 2023
End Date
December 31, 2025
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

Speed of information processing assessment

Time Frame: 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)

Time Frame: 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)

Memory disorder assessment

Time Frame: 3 months after ICU discharge

Administration of the Reading Span (working memory) test (a Z-score will be used to score this item)

Executive function assessment

Time Frame: 3 months after ICU discharge

Administration of the Go/No-go test (a Z-score will be used to score this item)

Blood neurological biomarkers levels

Time Frame: 3 months after ICU discharge

Measurement of blood levels of neurofilament light chain

Study Sites (1)

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