NCT05953311

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Jun 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 23, 2023

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

June 29, 2023

Completed
21 days until next milestone

First Posted

Study publicly available on registry

July 20, 2023

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2025

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

July 20, 2023

Status Verified

June 1, 2023

Enrollment Period

2 years

First QC Date

June 29, 2023

Last Update Submit

July 11, 2023

Conditions

Intensive Care Unit SyndromePost-intensive Care SyndromeCognitive Disorder

Outcome Measures

Primary Outcomes (29)

  • 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

Study Arms (1)

ICU survivors

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

Other: Blood analysisOther: Cognitive tests

Interventions

Blood analysisOTHER

Blood analysis for neurological biomarkers measurements

ICU survivors
Cognitive testsOTHER

Questionnaires assessing cognitive function

ICU survivors

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Anticipated ICU stay of at least 7 days for sepsis, acute respiratory distress syndrome, severe burns
  • French speaking

You may not qualify if:

  • hearing loss or blindness
  • mental retardation
  • known cognitive disorders or dementia
  • ICU admission for neurological disease
  • refusal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of Liège

Liège, 4000, Belgium

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood samples

MeSH Terms

Conditions

postintensive care syndromeCognitive Dysfunction

Interventions

Hematologic TestsNeuropsychological Tests

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Clinical Laboratory TechniquesDiagnostic Techniques and ProceduresDiagnosisInvestigative TechniquesPsychological TestsBehavioral Disciplines and Activities

Study Officials

  • Anne-Françoise Rousseau, MD, PhD

    University hospital of Liège

    STUDY DIRECTOR

Central Study Contacts

Anne-Françoise Rousseau, MD, PhD

CONTACT

+3243234776afrousseau@chuliege.be

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 29, 2023

First Posted

July 20, 2023

Study Start

June 23, 2023

Primary Completion

June 30, 2025

Study Completion

December 31, 2025

Last Updated

July 20, 2023

Record last verified: 2023-06

Data Sharing

IPD Sharing
Will not share

Locations

BE(1)