Impact of Post-ARDS Covid Sedation on Persistent Neuroinflammation (PET-DEXDOCOVID)

Status: Recruiting
Location: See location...
Study Type: Observational
SUMMARY

ICU Patients admitted after ARDS due to COVID infection should be weaned from invasive mechanical ventilation as quickly as possible. 60% of ARDS patient after COVID infection admitted in ICU developp a delirium during mechanical ventilation weaning, serious event that can lead to death or acute and late complications since 30% of patients who had a delirium in ICU develop cognitive sequelae. Based on epidemiological arguments and mouse models, severe neuroinflammation is considered to be one of the physiopathological mechanisms causing delirium during ventilatory weaning. In addition to its sedative properties, dexmedetomidine exhibits neuroprotective effects. In experimental models, dexmedetomidine reduces brain inflammation acting directly on the microglial phenotype. The role of this chronic neuroinflammatory condition on cognitive abilities and reserve begins to emerge in the literature no matter the initial stress is (surgery, head trauma, or Alzheimer's type dementia) and is therefore able to influence quality of life. The evaluation of this neuroinflammation by non-invasive tools appears essential in the management and follow-up of post-COVID cerebrolesed patients, as well as the potentially neuroprotective evaluation of dexmedetomidine.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 74
Healthy Volunteers: f
View:

• Adult patient (age ≥ 18 years at the time of inclusion) under 75 years old

• COVID-19 infection documented by PCR test performed on a nasopharyngeal swab or from a bronchoalveolar sample

• High affinity homozygous TPSO genotyping for \[18F\] -DPA-714 or heterozygous intermediate affinity for \[18F\] -DPA-714

• Patient who was hospitalized in intensive care for ARDS after COVID infection which required mechanical ventilation and deep sedation for at least 24 hours

• Patient alive at 24 months (+ 24 months) after discharge from intensive care

• Signature of informed consent

• Patient affiliated to a National French social security system, excluding (French) State Medical Aid (SMA)

⁃ For the group of patients exposed to dexmedetomidine:

• Administration of dexmedetomidine for at least 24 hours during intensive care hospitalization

⁃ For the group of patients not exposed to dexmedetomidine:

• No administration of dexmedetomidine during intensive care hospitalization

Locations
Other Locations
France
Anesthesy department - Hôpital Pitié Salpêtrière
RECRUITING
Paris
Contact Information
Primary
Vincent DEGOS, Pr
vincent.degos@aphp.fr
(0)1 42 16 37 61
Backup
Laurence JALIN, Dr
laurence.jalin@aphp.fr
(0)1 42 16 34 23
Time Frame
Start Date: 2022-03-21
Estimated Completion Date: 2026-02-04
Participants
Target number of participants: 72
Treatments
Exposed to Dexmedetomidine during ICU stay
Dexmedetomidine has been administered in accordance with its MA (at least 24 hours continuously with a starting dose of 0.7 µg/kg/h and then adjusted to sedation scores between 0.4 and 1.1 µg/kg/h), as part of care, prior to inclusion in the protocol
Not Exposed to Dexmedetomidine during ICU stay
Standard of care
Related Therapeutic Areas
Sponsors
Leads: Assistance Publique - Hôpitaux de Paris

This content was sourced from clinicaltrials.gov