Intensive Care Unit Syndrome Clinical Trial
— COGNISIOfficial title:
The Relationship Between Neurological Blood-based Biomarkers and Mid-term Cognitive Disorders in Critically Ill Survivors.
NCT number | NCT05953311 |
Other study ID # | COGNISI |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 23, 2023 |
Est. completion date | December 31, 2025 |
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.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | December 31, 2025 |
Est. primary completion date | June 30, 2025 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 75 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Belgium | University Hospital of Liège | Liège |
Lead Sponsor | Collaborator |
---|---|
University of Liege |
Belgium,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Blood neurological biomarkers levels | Measurement of blood levels of S100ß protein | ICU Admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of S100ß protein | day 3 after ICU admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of S100ß protein | day 7 after ICU admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of S100ß protein | day 14 after ICU admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of S100ß protein | 3 months after ICU discharge | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of neuron specific enolase | ICU Admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of neuron specific enolase | day 3 after ICU admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of neuron specific enolase | day 7 after ICU admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of neuron specific enolase | day 14 after ICU admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of neuron specific enolase | 3 months after ICU discharge | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of total Tau protein | ICU Admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of total Tau protein | day 3 after ICU admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of total Tau protein | day 7 after ICU admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of total Tau protein | day 14 after ICU admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of total Tau protein | 3 months after ICU discharge | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of neurofilament light chain | ICU Admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of neurofilament light chain | day 3 after ICU admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of neurofilament light chain | day 7 after ICU admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of neurofilament light chain | day 14 after ICU admission | |
Primary | Blood neurological biomarkers levels | Measurement of blood levels of neurofilament light chain | 3 months after ICU discharge | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | Executive function assessment | Administration of the Trail Making Test (a Z-score will be used to score this item) | 3 months after ICU discharge | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Active, not recruiting |
NCT06277518 -
System for Postoperative Admission to ICU for Patients With Digestive System Malignancy
|
||
Completed |
NCT06251791 -
Inspiratory Muscle Training and Expiratory Muscle Thickness
|
N/A | |
Completed |
NCT04110509 -
Fragility and Programmed Cardiovascular Surgery (EcoSarco)
|
||
Not yet recruiting |
NCT03247062 -
Sleep Bundle for Improving Sleep in ICU Patients
|
N/A | |
Recruiting |
NCT05587595 -
Transition From Paediatric Intensive Care to General Paediatrics and Pneumology Units : a Study of the Post-intensive Care Syndrome
|
||
Active, not recruiting |
NCT05299346 -
Post-ICU Follow-up Study in Covid-19 Patients
|
||
Recruiting |
NCT04112420 -
Detection of the Incidence of Pre-existing Cardio-pulmonary Diseases by Using of Echocardiography
|
N/A | |
Recruiting |
NCT05491590 -
Patient-reported Outcome After Status Epilepticus
|
||
Recruiting |
NCT05155150 -
Improving Shared-Decision Making in the Intensive Care Unit Using Patient-reported Outcome Information
|
N/A | |
Completed |
NCT03642249 -
Education for Recognition and Management of Delirium
|
N/A | |
Withdrawn |
NCT03138278 -
Impact on Family or Care-givers of Very Old ICU-survivors, Trajectories and 6 Months' Outcome in the Very Old.
|
N/A | |
Completed |
NCT02784574 -
Post ICU Follow up: A Questionnaire Survey of Aftercare in Denmark
|
N/A | |
Completed |
NCT04412980 -
Ionized Magnesium for Monitoring of Citrate-anticoagulated CVVHD
|
||
Completed |
NCT04378504 -
In Hospital Course of Acute Coronary Artery Syndromes
|
||
Completed |
NCT03457376 -
Correlation of the Hand Grip Force With Maximum Inspiratory and Maximum Expiratory Pressure, in Critical Ill Patients
|
N/A | |
Completed |
NCT03124342 -
Vanderbilt ICU Recovery Program Pilot Trial
|
N/A | |
Completed |
NCT03885687 -
Exercise With Music for ICU Survivors
|
N/A | |
Completed |
NCT03828552 -
Parents' Experience of Their Children Stay in a Pediatric Intensive Care Unit.
|
||
Completed |
NCT03392857 -
End Of Life in the Critically Ill patiEnt
|
||
Recruiting |
NCT05795569 -
Removal of Nasogastric Feeding Tube Post Extubation in ICU : a Prospective Randomized Trial
|
N/A |