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

Sponsor
University of Liege (Other)
Overall Status
Recruiting
CT.gov ID
NCT05953311
Collaborator
(none)
30
Enrollment
1
Location
30.3
Anticipated Duration (Months)
1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Blood analysis
  • Other: Cognitive tests

Study Design

Study Type:
Observational
Anticipated Enrollment :
30 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
The Relationship Between Neurological Blood-based Biomarkers and Mid-term Cognitive Disorders in Critically Ill Survivors.
Actual Study Start Date :
Jun 23, 2023
Anticipated Primary Completion Date :
Jun 30, 2025
Anticipated Study Completion Date :
Dec 31, 2025

Arms and Interventions

Arm Intervention/Treatment
ICU survivors

Cohort of patients who survive an ICU stay of at least 7 days

Other: Blood analysis
Blood analysis for neurological biomarkers measurements

Other: Cognitive tests
Questionnaires assessing cognitive function

Outcome Measures

Primary Outcome Measures

  1. Blood neurological biomarkers levels [ICU Admission]

    Measurement of blood levels of S100β protein

  2. Blood neurological biomarkers levels [day 3 after ICU admission]

    Measurement of blood levels of S100β protein

  3. Blood neurological biomarkers levels [day 7 after ICU admission]

    Measurement of blood levels of S100β protein

  4. Blood neurological biomarkers levels [day 14 after ICU admission]

    Measurement of blood levels of S100β protein

  5. Blood neurological biomarkers levels [3 months after ICU discharge]

    Measurement of blood levels of S100β protein

  6. Blood neurological biomarkers levels [ICU Admission]

    Measurement of blood levels of neuron specific enolase

  7. Blood neurological biomarkers levels [day 3 after ICU admission]

    Measurement of blood levels of neuron specific enolase

  8. Blood neurological biomarkers levels [day 7 after ICU admission]

    Measurement of blood levels of neuron specific enolase

  9. Blood neurological biomarkers levels [day 14 after ICU admission]

    Measurement of blood levels of neuron specific enolase

  10. Blood neurological biomarkers levels [3 months after ICU discharge]

    Measurement of blood levels of neuron specific enolase

  11. Blood neurological biomarkers levels [ICU Admission]

    Measurement of blood levels of total Tau protein

  12. Blood neurological biomarkers levels [day 3 after ICU admission]

    Measurement of blood levels of total Tau protein

  13. Blood neurological biomarkers levels [day 7 after ICU admission]

    Measurement of blood levels of total Tau protein

  14. Blood neurological biomarkers levels [day 14 after ICU admission]

    Measurement of blood levels of total Tau protein

  15. Blood neurological biomarkers levels [3 months after ICU discharge]

    Measurement of blood levels of total Tau protein

  16. Blood neurological biomarkers levels [ICU Admission]

    Measurement of blood levels of neurofilament light chain

  17. Blood neurological biomarkers levels [day 3 after ICU admission]

    Measurement of blood levels of neurofilament light chain

  18. Blood neurological biomarkers levels [day 7 after ICU admission]

    Measurement of blood levels of neurofilament light chain

  19. Blood neurological biomarkers levels [day 14 after ICU admission]

    Measurement of blood levels of neurofilament light chain

  20. Blood neurological biomarkers levels [3 months after ICU discharge]

    Measurement of blood levels of neurofilament light chain

  21. Cognitive disorders assessment (global assessment) [the day after ICU discharge]

    Administration of the MOCA questionnaire (Montreal Cognitive Assessment) : scoring from 0 to 30, the highest score meaning the better cognitive outcome)

  22. 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)

  23. Memory disorder assessment [3 months after ICU discharge]

    Administration of the California Verbal Learning Test: a Z-score will be used to score this item

  24. Memory disorder assessment [3 months after ICU discharge]

    Administration of the Brief Visuospatial Memory Test (a Z-score will be used to score this item)

  25. 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)

  26. Executive function assessment [3 months after ICU discharge]

    Administration of the Trail Making Test (a Z-score will be used to score this item)

  27. 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)

  28. Executive function assessment [3 months after ICU discharge]

    Administration of the Stroop Color and Word Test (a Z-score will be used to score this item)

  29. 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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 University Hospital of Liège Liège Belgium 4000

Sponsors and Collaborators

  • University of Liege

Investigators

  • Study Director: Anne-Françoise Rousseau, MD, PhD, University Hospital of Liège

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
University of Liege
ClinicalTrials.gov Identifier:
NCT05953311
Other Study ID Numbers:
  • COGNISI
First Posted:
Jul 20, 2023
Last Update Posted:
Jul 20, 2023
Last Verified:
Jun 1, 2023
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:
Syndrome
Cognitive Dysfunction
Cognition Disorders

Study Results

No Results Posted as of Jul 20, 2023