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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Intensive Care Unit Syndrome; Cognitive Disorder; Post-intensive Care Syndrome
• Intervention / Treatment: Other: Blood analysis; Other: Cognitive tests

• Study Type: Observational
• Enrollment (Estimated): 30

Contacts and Locations

• Study Contact: Name: Anne-Françoise Rousseau, MD, PhD; Phone Number: +3243234776; Email: afrousseau@chuliege.be

Study Locations

• Belgium
  • Liège, Belgium, 4000
    • Recruiting
    • University Hospital of Liege
    • Contact: Anne-Françoise Rousseau, MD, PhD; Phone Number: +3243234776; Email: afrousseau@chuliege.be
    • Sub-Investigator: Gael Delrue

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Patients who survive an ICU stay of at least 7 days and who are assessed 3 months after ICU discharge

Description

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 Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood neurological biomarkers levels	Measurement of blood levels of S100β protein	ICU Admission
Blood neurological biomarkers levels	Measurement of blood levels of S100β protein	day 3 after ICU admission
Blood neurological biomarkers levels	Measurement of blood levels of S100β protein	day 7 after ICU admission
Blood neurological biomarkers levels	Measurement of blood levels of S100β protein	day 14 after ICU admission
Blood neurological biomarkers levels	Measurement of blood levels of S100β protein	3 months after ICU discharge
Blood neurological biomarkers levels	Measurement of blood levels of neuron specific enolase	ICU Admission
Blood neurological biomarkers levels	Measurement of blood levels of neuron specific enolase	day 3 after ICU admission
Blood neurological biomarkers levels	Measurement of blood levels of neuron specific enolase	day 7 after ICU admission
Blood neurological biomarkers levels	Measurement of blood levels of neuron specific enolase	day 14 after ICU admission
Blood neurological biomarkers levels	Measurement of blood levels of neuron specific enolase	3 months after ICU discharge
Blood neurological biomarkers levels	Measurement of blood levels of total Tau protein	ICU Admission
Blood neurological biomarkers levels	Measurement of blood levels of total Tau protein	day 3 after ICU admission
Blood neurological biomarkers levels	Measurement of blood levels of total Tau protein	day 7 after ICU admission
Blood neurological biomarkers levels	Measurement of blood levels of total Tau protein	day 14 after ICU admission
Blood neurological biomarkers levels	Measurement of blood levels of total Tau protein	3 months after ICU discharge
Blood neurological biomarkers levels	Measurement of blood levels of neurofilament light chain	ICU Admission
Blood neurological biomarkers levels	Measurement of blood levels of neurofilament light chain	day 3 after ICU admission
Blood neurological biomarkers levels	Measurement of blood levels of neurofilament light chain	day 7 after ICU admission
Blood neurological biomarkers levels	Measurement of blood levels of neurofilament light chain	day 14 after ICU admission
Blood neurological biomarkers levels	Measurement of blood levels of neurofilament light chain	3 months after ICU discharge
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
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
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
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
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
Executive function assessment	Administration of the Trail Making Test (a Z-score will be used to score this item)	3 months after ICU discharge
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
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
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

Collaborators and Investigators

• Sponsor: University of Liege
• Investigators: Study Director: Anne-Françoise Rousseau, MD, PhD, University Hospital of Liege

Study record dates

Study Major Dates

• Study Start (Actual): June 23, 2023
• Primary Completion (Estimated): June 30, 2025
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: June 29, 2023
• First Submitted That Met QC Criteria: July 11, 2023
• First Posted (Actual): July 20, 2023

Study Record Updates

• Last Update Posted (Actual): July 20, 2023
• Last Update Submitted That Met QC Criteria: July 11, 2023
• Last Verified: June 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Pathologic Processes; Neurocognitive Disorders; Disease; Syndrome; Cognitive Dysfunction; Cognition Disorders
• Other Study ID Numbers: COGNISI

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No