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

NCT ID: NCT04643548

Last Updated: 2020-12-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

20 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-10-13

Study Completion Date

2021-08-13

Brief Summary

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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

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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.

Conditions

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SARS-CoV-2 Infection Intensive Care Unit Patient Neurological Abnormality Delirium Encephalopathy

Keywords

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SARS-CoV-2 infection Intensive care unit patient Neurological abnormalities Delirium Encephalopathy

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Lise Laclautre

Role: CONTACT

Phone: +33 4 754 963

Email: [email protected]

Facility Contacts

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Thomas Godet

Role: primary

Benjamin Rieu

Role: backup

Other Identifiers

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NeuroCovid-RNI 2020 GODET

Identifier Type: -

Identifier Source: org_study_id