RecruitingNot Applicable

Impact of Post-ARDS Covid-19 Sedation on Persistent Neuroinflammation

France72 participantsStarted 2022-03-21

Plain-language 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.

Who can participate

Age range18 Years – 74 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * Protected adult (under legal protection, guardianship or curatorship) * Pregnancy or breast-feeding * Contraindication to PET or MRI examination * Severe renal impairment (creatinine clearance \<30 mL / min) * Contraindication to the administration of the radiopharmaceutical agent \[18F\]-DPA-714 * Serious neurological history at admission to intensive care: * Stroke * Severe head trauma * Dementia with loss of autonomy

What they're measuring

Mean of SUVr of [18F]-DPA-714 in frontal lobes compared to cerebellar lobes

Timeframe: 24 months (+ 24 months) after ICU discharge

Trial details

NCT IDNCT05233605

SponsorAssistance Publique - Hôpitaux de Paris

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-02-04

Contact for this trial

Vincent DEGOS, Pr

(0)1 42 16 37 61 vincent.degos@aphp.fr