NCT04643548

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 13, 2020

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 16, 2020

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 25, 2020

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 13, 2021

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 13, 2021

Completed
Last Updated

December 1, 2020

Status Verified

November 1, 2020

Enrollment Period

8 months

First QC Date

November 16, 2020

Last Update Submit

November 28, 2020

Conditions

SARS-CoV-2 InfectionIntensive Care Unit PatientNeurological AbnormalityDeliriumEncephalopathy

Keywords

SARS-CoV-2 infectionIntensive care unit patientNeurological abnormalitiesDeliriumEncephalopathy

Outcome Measures

Primary Outcomes (2)

  • 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

  • Dosage of neuronal injury markers

    S100 β, 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 Outcomes (8)

  • Delirium assessment

    Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days

  • Delirium assessment

    Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days

  • Coma assessment

    Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days

  • Pupils characteristics

    Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days

  • Pupils characteristics

    Change from Day 0 (= First day in ICU) until the end of the stay (up to 3 months) - Assessments every days

  • +3 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients hospitalized in Intensive Care Unit and infected bye SARS-CoV-2

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU

Clermont-Ferrand, 63000, France

RECRUITING

MeSH Terms

Conditions

COVID-19Nervous System MalformationsDeliriumBrain Diseases

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract DiseasesNervous System DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesConfusionNeurobehavioral ManifestationsNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsNeurocognitive DisordersMental DisordersCentral Nervous System Diseases

Central Study Contacts

Lise Laclautre

CONTACT

+33 4 754 963llaclautre_perrier@chu-clermontferrand.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 16, 2020

First Posted

November 25, 2020

Study Start

October 13, 2020

Primary Completion

June 13, 2021

Study Completion

August 13, 2021

Last Updated

December 1, 2020

Record last verified: 2020-11

Locations

FR(1)