Clinical trial NCT04643548: WHO Covid 19 - Neurological Abnormalities in SARS-CoV-2 ICU Patients
Official title: Neurological Abnormalities in SARS-CoV-2 ICU Patients. A Prospective Study. NeuroCOVID Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV-2 Infection
Intensive Care Unit Patient
Neurological Abnormality
Delirium
Encephalopathy
Keywords: SARS-CoV-2 infection
Intensive care unit patient
Neurological abnormalities
Delirium
Encephalopathy
Lead sponsor: University Hospital, Clermont-Ferrand
Sponsor class: OTHER
First posted: 2020-11-25
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients hospitalized in Intensive Care Unit and infected bye SARS-CoV-2

Brief summary: The SARS-CoV-2 epidemic is leading to a large number of patients in intensive care units due to severe hypoxemic pneumonia. After an acute phase that may require controlled mechanical ventilation and deep sedation, removal of sedation often reveals a pathological awakening in the vast majority of patients. This encephalopathy state remains, to date and to our knowledge, unexplained. Clinical features do not appear to fully correlate with regular delirium. This encephalopathy might be explained by deep and prolonged hypoxemia, a wide use of sedation drugs, systemic inflammation or the hostile ICU environment.

Detailed description: This study is intended to investigate neurological abnormalities associated with SARS-CoV-2 infection. Complete daily neurological examinations will be routinely conducted in intensive care unit patients. Specific biological analyses will also be performed in these patients by collecting additional blood samples from an arterial or central catheter, every 2 days. These clinical and biological examinations will be continued throughout patient's stay in the intensive care unit.

Eligibility criteria: Inclusion Criteria:

* Age ≥ 18 years old
* COVID-19 positive patient (positive RT PCR, nasopharyngeal or tracheal)
* Patient admitted in an intensive care unit of the department of Anesthesia, Critical Care and Perioperative of Clermont-Ferrand University Hospital
* Patient with an arterial or central catheter to perform blood samples collection

Exclusion Criteria:

* Patient or family member's refusal to participate
* Neuropsychiatric history that may interfere with neurological evaluations in the intensive care unit
* Patient not affiliated with French social security insurance
* Patient under legal guardianship

Primary outcomes:
measure: Dosage of biomarkers typically explored in intensive care unit delirium
timeFrame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every 2 days
measure: Dosage of neuronal injury markers
timeFrame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every 2 days
Secondary outcomes:
measure: Delirium assessment
timeFrame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
measure: Delirium assessment
timeFrame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
measure: Coma assessment
timeFrame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
measure: Pupils characteristics
timeFrame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
measure: Pupils characteristics
timeFrame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
measure: Neurological abnormalities
timeFrame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
measure: Neurological abnormalities
timeFrame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
measure: Neurological abnormalities
timeFrame: Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Other outcomes:
Locations:
city: Clermont-Ferrand
country: France
facility: CHU
Study officials:
References: