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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05953311
Other study ID # COGNISI
Secondary ID
Status Recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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