Clinical trial NCT05953311: Neurological Blood-based Biomarkers and Cognitive Disorders in Critically Ill Survivors.
Official title: The Relationship Between Neurological Blood-based Biomarkers and Mid-term Cognitive Disorders in Critically Ill Survivors.
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Intensive Care Unit Syndrome
Post-intensive Care Syndrome
Cognitive Disorder
Lead sponsor: University of Liege
Sponsor class: OTHER
First posted: 2023-07-20
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.


Eligibility criteria: 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

Primary outcomes:
measure: Blood neurological biomarkers levels
timeFrame: ICU Admission
measure: Blood neurological biomarkers levels
timeFrame: day 3 after ICU admission
measure: Blood neurological biomarkers levels
timeFrame: day 7 after ICU admission
measure: Blood neurological biomarkers levels
timeFrame: day 14 after ICU admission
measure: Blood neurological biomarkers levels
timeFrame: 3 months after ICU discharge
measure: Blood neurological biomarkers levels
timeFrame: ICU Admission
measure: Blood neurological biomarkers levels
timeFrame: day 3 after ICU admission
measure: Blood neurological biomarkers levels
timeFrame: day 7 after ICU admission
measure: Blood neurological biomarkers levels
timeFrame: day 14 after ICU admission
measure: Blood neurological biomarkers levels
timeFrame: 3 months after ICU discharge
measure: Blood neurological biomarkers levels
timeFrame: ICU Admission
measure: Blood neurological biomarkers levels
timeFrame: day 3 after ICU admission
measure: Blood neurological biomarkers levels
timeFrame: day 7 after ICU admission
measure: Blood neurological biomarkers levels
timeFrame: day 14 after ICU admission
measure: Blood neurological biomarkers levels
timeFrame: 3 months after ICU discharge
measure: Blood neurological biomarkers levels
timeFrame: ICU Admission
measure: Blood neurological biomarkers levels
timeFrame: day 3 after ICU admission
measure: Blood neurological biomarkers levels
timeFrame: day 7 after ICU admission
measure: Blood neurological biomarkers levels
timeFrame: day 14 after ICU admission
measure: Blood neurological biomarkers levels
timeFrame: 3 months after ICU discharge
measure: Cognitive disorders assessment (global assessment)
timeFrame: the day after ICU discharge
measure: Cognitive disorders assessment (global assessment)
timeFrame: 3 months after ICU discharge
measure: Memory disorder assessment
timeFrame: 3 months after ICU discharge
measure: Memory disorder assessment
timeFrame: 3 months after ICU discharge
measure: Speed of information processing assessment
timeFrame: 3 months after ICU discharge
measure: Executive function assessment
timeFrame: 3 months after ICU discharge
measure: Memory disorder assessment
timeFrame: 3 months after ICU discharge
measure: Executive function assessment
timeFrame: 3 months after ICU discharge
measure: Executive function assessment
timeFrame: 3 months after ICU discharge
Secondary outcomes:
Other outcomes:
Locations:
city: Liège
country: Belgium
facility: University Hospital of Liège
Study officials:
affiliation: University hospital of Liège
name: Anne-Françoise Rousseau, MD, PhD
role: STUDY_DIRECTOR
References: