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

July 11, 2023 updated by: University of Liege

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Belgium
      • Liège, Belgium, 4000
        • Recruiting
        • University Hospital of Liege
        • Contact:
        • Sub-Investigator:
          • Gael Delrue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Blood neurological biomarkers levels
Time Frame: ICU Admission
Measurement of blood levels of S100β protein
ICU Admission
Blood neurological biomarkers levels
Time Frame: day 3 after ICU admission
Measurement of blood levels of S100β protein
day 3 after ICU admission
Blood neurological biomarkers levels
Time Frame: day 7 after ICU admission
Measurement of blood levels of S100β protein
day 7 after ICU admission
Blood neurological biomarkers levels
Time Frame: day 14 after ICU admission
Measurement of blood levels of S100β protein
day 14 after ICU admission
Blood neurological biomarkers levels
Time Frame: 3 months after ICU discharge
Measurement of blood levels of S100β protein
3 months after ICU discharge
Blood neurological biomarkers levels
Time Frame: ICU Admission
Measurement of blood levels of neuron specific enolase
ICU Admission
Blood neurological biomarkers levels
Time Frame: day 3 after ICU admission
Measurement of blood levels of neuron specific enolase
day 3 after ICU admission
Blood neurological biomarkers levels
Time Frame: day 7 after ICU admission
Measurement of blood levels of neuron specific enolase
day 7 after ICU admission
Blood neurological biomarkers levels
Time Frame: day 14 after ICU admission
Measurement of blood levels of neuron specific enolase
day 14 after ICU admission
Blood neurological biomarkers levels
Time Frame: 3 months after ICU discharge
Measurement of blood levels of neuron specific enolase
3 months after ICU discharge
Blood neurological biomarkers levels
Time Frame: ICU Admission
Measurement of blood levels of total Tau protein
ICU Admission
Blood neurological biomarkers levels
Time Frame: day 3 after ICU admission
Measurement of blood levels of total Tau protein
day 3 after ICU admission
Blood neurological biomarkers levels
Time Frame: day 7 after ICU admission
Measurement of blood levels of total Tau protein
day 7 after ICU admission
Blood neurological biomarkers levels
Time Frame: day 14 after ICU admission
Measurement of blood levels of total Tau protein
day 14 after ICU admission
Blood neurological biomarkers levels
Time Frame: 3 months after ICU discharge
Measurement of blood levels of total Tau protein
3 months after ICU discharge
Blood neurological biomarkers levels
Time Frame: ICU Admission
Measurement of blood levels of neurofilament light chain
ICU Admission
Blood neurological biomarkers levels
Time Frame: day 3 after ICU admission
Measurement of blood levels of neurofilament light chain
day 3 after ICU admission
Blood neurological biomarkers levels
Time Frame: day 7 after ICU admission
Measurement of blood levels of neurofilament light chain
day 7 after ICU admission
Blood neurological biomarkers levels
Time Frame: day 14 after ICU admission
Measurement of blood levels of neurofilament light chain
day 14 after ICU admission
Blood neurological biomarkers levels
Time Frame: 3 months after ICU discharge
Measurement of blood levels of neurofilament light chain
3 months after ICU discharge
Cognitive disorders assessment (global assessment)
Time Frame: 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)
the day after ICU discharge
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)
3 months after ICU discharge
Memory disorder assessment
Time Frame: 3 months after ICU discharge
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
Time Frame: 3 months after ICU discharge
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
Time Frame: 3 months after ICU discharge
Administration of the Ways IV test (a Z-score will be used to score this item)
3 months after ICU discharge
Executive function assessment
Time Frame: 3 months after ICU discharge
Administration of the Trail Making Test (a Z-score will be used to score this item)
3 months after ICU discharge
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)
3 months after ICU discharge
Executive function assessment
Time Frame: 3 months after ICU discharge
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
Time Frame: 3 months after ICU discharge
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Liege

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Anne-Françoise Rousseau, MD, PhD, University Hospital of Liege

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 23, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2025

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2025

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 29, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 20, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 20, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 11, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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