Intensive Care Unit SyndromeCOGNISINCT05953311
Neurological Blood-based Biomarkers and Cognitive Disorders in Critically Ill Survivors.
An observational study of Intensive Care Unit Syndrome and Post-intensive Care Syndrome, run by University of Liege at 1 site in Belgium.
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Intensive Care Unit Syndrome, Post-intensive Care Syndrome, Cognitive Disorder
- What is being tested?
- Blood analysis and Cognitive tests
- How many people
- 30 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Jun 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who survive an ICU stay of at least 7 days and who are assessed 3 months after ICU discharge
Who may be able to join
- Anticipated ICU stay of at least 7 days for sepsis, acute respiratory distress syndrome, severe burns
- French speaking
Who cannot join
- hearing loss or blindness
- mental retardation
- known cognitive disorders or dementia
- ICU admission for neurological disease
- refusal
Trial locations and contacts
1 site in 1 country.
Belgium1 site, 1 recruiting
- Recruiting
University Hospital of Liège
Liège, 4000
Anne-Françoise Rousseau, MD, PhD, +3243234776, afrousseau@chuliege.be
Gael Delrue
About this study
Official title: 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.
- Being tested
- Blood analysis, Cognitive tests
- Medical subject headings
- postintensive care syndrome, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood analysisOther
Blood analysis for neurological biomarkers measurements
Cognitive testsOther
Questionnaires assessing cognitive function
| Study group | Role | What they receive |
|---|---|---|
| ICU survivors | Cohort of patients who survive an ICU stay of at least 7 days Receives: Other: Blood analysis; Other: Cognitive tests |
What is being measured
The primary outcome is the main question the study is designed to answer.
Blood neurological biomarkers levels
Measurement of blood levels of S100β protein
Measured: ICU Admission
Blood neurological biomarkers levels
Measurement of blood levels of S100β protein
Measured: day 3 after ICU admission
Blood neurological biomarkers levels
Measurement of blood levels of S100β protein
Measured: day 7 after ICU admission
Blood neurological biomarkers levels
Measurement of blood levels of S100β protein
Measured: day 14 after ICU admission
Blood neurological biomarkers levels
Measurement of blood levels of S100β protein
Measured: 3 months after ICU discharge
Blood neurological biomarkers levels
Measurement of blood levels of neuron specific enolase
Measured: ICU Admission
Blood neurological biomarkers levels
Measurement of blood levels of neuron specific enolase
Measured: day 3 after ICU admission
Blood neurological biomarkers levels
Measurement of blood levels of neuron specific enolase
Measured: day 7 after ICU admission
Blood neurological biomarkers levels
Measurement of blood levels of neuron specific enolase
Measured: day 14 after ICU admission
Blood neurological biomarkers levels
Measurement of blood levels of neuron specific enolase
Measured: 3 months after ICU discharge
Blood neurological biomarkers levels
Measurement of blood levels of total Tau protein
Measured: ICU Admission
Blood neurological biomarkers levels
Measurement of blood levels of total Tau protein
Measured: day 3 after ICU admission
Blood neurological biomarkers levels
Measurement of blood levels of total Tau protein
Measured: day 7 after ICU admission
Blood neurological biomarkers levels
Measurement of blood levels of total Tau protein
Measured: day 14 after ICU admission
Blood neurological biomarkers levels
Measurement of blood levels of total Tau protein
Measured: 3 months after ICU discharge
Blood neurological biomarkers levels
Measurement of blood levels of neurofilament light chain
Measured: ICU Admission
Blood neurological biomarkers levels
Measurement of blood levels of neurofilament light chain
Measured: day 3 after ICU admission
Blood neurological biomarkers levels
Measurement of blood levels of neurofilament light chain
Measured: day 7 after ICU admission
Blood neurological biomarkers levels
Measurement of blood levels of neurofilament light chain
Measured: day 14 after ICU admission
Blood neurological biomarkers levels
Measurement of blood levels of neurofilament light chain
Measured: 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)
Measured: 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)
Measured: 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
Measured: 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)
Measured: 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)
Measured: 3 months after ICU discharge
Executive function assessment
Administration of the Trail Making Test (a Z-score will be used to score this item)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 3 months after ICU discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2023
- Study start23 Jun 2023
- Primary completion30 Jun 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Intensive Care Unit SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Liege
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anne-Françoise Rousseau, MD, PhD, Study director, Centre Hospitalier Universitaire de Liege
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05953311
- Sponsor's protocol ID
- COGNISI
- Acronym
- COGNISI
- Status last verified
- Jun 2023
- First submitted
- 29 Jun 2023
- Last updated
- 20 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Relationship Between Neurological Blood-based Biomarkers and Mid-term Cognitive Disorders in Critically Ill Survivors.
- ClinicalTrials.gov ID
- NCT05953311
- Acronym / sponsor ID
- COGNISI / COGNISI
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- University of LiegeUniversity, hospital or other
- Study start
- 23 Jun 2023 (actual)
- Primary completion
- 30 Jun 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ICU survivors | – | Other: Blood analysis, Other: Cognitive testsCohort of patients who survive an ICU stay of at least 7 days |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who survive an ICU stay of at least 7 days and who are assessed 3 months after ICU discharge
Key inclusion criteria (2 listed)
- Anticipated ICU stay of at least 7 days for sepsis, acute respiratory distress syndrome, severe burns
- French speaking
Key exclusion criteria (5 listed)
- hearing loss or blindness
- mental retardation
- known cognitive disorders or dementia
- ICU admission for neurological disease
- refusal
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood analysisBlood analysis for neurological biomarkers measurements | Other | ICU survivors |
| Cognitive testsQuestionnaires assessing cognitive function | Other | ICU survivors |
Primary outcome
Blood neurological biomarkers levels
Time frame: ICU Admission
Measurement of blood levels of S100β protein
Blood neurological biomarkers levels
Time frame: day 3 after ICU admission
Measurement of blood levels of S100β protein
Blood neurological biomarkers levels
Time frame: day 7 after ICU admission
Measurement of blood levels of S100β protein
Blood neurological biomarkers levels
Time frame: day 14 after ICU admission
Measurement of blood levels of S100β protein
Blood neurological biomarkers levels
Time frame: 3 months after ICU discharge
Measurement of blood levels of S100β protein
Blood neurological biomarkers levels
Time frame: ICU Admission
Measurement of blood levels of neuron specific enolase
Blood neurological biomarkers levels
Time frame: day 3 after ICU admission
Measurement of blood levels of neuron specific enolase
Blood neurological biomarkers levels
Time frame: day 7 after ICU admission
Measurement of blood levels of neuron specific enolase
Blood neurological biomarkers levels
Time frame: day 14 after ICU admission
Measurement of blood levels of neuron specific enolase
Blood neurological biomarkers levels
Time frame: 3 months after ICU discharge
Measurement of blood levels of neuron specific enolase
Blood neurological biomarkers levels
Time frame: ICU Admission
Measurement of blood levels of total Tau protein
Blood neurological biomarkers levels
Time frame: day 3 after ICU admission
Measurement of blood levels of total Tau protein
Blood neurological biomarkers levels
Time frame: day 7 after ICU admission
Measurement of blood levels of total Tau protein
Blood neurological biomarkers levels
Time frame: day 14 after ICU admission
Measurement of blood levels of total Tau protein
Blood neurological biomarkers levels
Time frame: 3 months after ICU discharge
Measurement of blood levels of total Tau protein
Blood neurological biomarkers levels
Time frame: ICU Admission
Measurement of blood levels of neurofilament light chain
Blood neurological biomarkers levels
Time frame: day 3 after ICU admission
Measurement of blood levels of neurofilament light chain
Blood neurological biomarkers levels
Time frame: day 7 after ICU admission
Measurement of blood levels of neurofilament light chain
Blood neurological biomarkers levels
Time frame: day 14 after ICU admission
Measurement of blood levels of neurofilament light chain
Blood neurological biomarkers levels
Time frame: 3 months after ICU discharge
Measurement of blood levels of neurofilament light chain
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)
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 California Verbal Learning Test: a Z-score will be used to score this item
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)
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)
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)
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 Stroop Color and Word 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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anne-Françoise Rousseau, MD, PhD study director
Centre Hospitalier Universitaire de Liege
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Intensive Care Unit Syndrome and Post-intensive Care Syndrome, run by University of Liege at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Anne-Françoise Rousseau, MD, PhD (+3243234776, afrousseau@chuliege.be), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Blood neurological biomarkers levels (time frame: ICU Admission). The study lists 29 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jul 2023.