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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04643548
Other study ID # NeuroCovid-RNI 2020 GODET
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date October 13, 2020
Est. completion date August 13, 2021

Study information

Verified date November 2020
Source University Hospital, Clermont-Ferrand
Contact Lise Laclautre
Phone +33 4 754 963
Email llaclautre_perrier@chu-clermontferrand.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 20
Est. completion date August 13, 2021
Est. primary completion date June 13, 2021
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Locations

Country Name City State
France CHU Clermont-Ferrand

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Dosage of biomarkers typically explored in intensive care unit delirium Plasminogen activator inhibitor-1 (PAI-1), E-selectin and angiopoietin-2 Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every 2 days
Primary Dosage of neuronal injury markers S100 ß, Neuron Specific Enolase (NSE), GFAP, UCHL1, NFL Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every 2 days
Secondary Delirium assessment CAM-ICU (Confusion Assessment Method - Intensive Care Unit) scale Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Secondary Delirium assessment ICDSC (Intensive Care Delirium Screening Checklist) scale. Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Secondary Coma assessment CRS-R (Coma Recovery Scale-Revised) Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Secondary Pupils characteristics Clinical observation Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Secondary Pupils characteristics Pupilometer assessment Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Secondary Neurological abnormalities Electroencephalogram : epileptic activity (spikes, spike-waves) or encephalopathy activity (triphasic waves)) Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Secondary Neurological abnormalities CT-scan Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
Secondary Neurological abnormalities MRI Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days
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