WHO Covid 19 - Neurological Abnormalities in SARS-CoV-2 ICU Patients

Delirium Clinical Trial

— NeuroCovid  

Official title:

Neurological Abnormalities in SARS-CoV-2 ICU Patients. A Prospective Study. NeuroCOVID Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04643548
• Other study ID #: NeuroCovid-RNI 2020 GODET
• Status: Recruiting
• 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
• 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
• 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

Related Conditions & MeSH terms

• Brain Diseases
• Congenital Abnormalities
• Delirium
• Encephalopathy
• Intensive Care Unit Patient
• Nervous System Malformations
• Neurological Abnormality
• SARS-CoV-2 Infection

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