All patients who have developed and survived ARDS linked to COVID-19 infection, admitted to intensive care units, meeting the study's inclusion criteria may be included in this research.
Conditions
Interventions
Trade Name: dexmedetomidine, all available commercial specialties may have been used (originator or generic)
Product Name: dexmedetomidine
Product Code: dexmedetomidine
Pharmaceutical Form: Concentr
Sponsors
Assistance Publique – Hôpitaux de Paris
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Adult patient (age = 18 years at the time of inclusion) under 75 years old • COVID-19 infection documented by nasopharyngeal pCR test. • High affinity homozygous TPSO genotyping for the radiotracer or heterozygous intermediate affinity for the radiotracer • Patient who was hospitalized in intensive care for an ARDS following the COVID infection requiring mechanical ventilation and deep sedation for at least 48 hours. • Patient alive 12 months (+/- 3 months) after discharge from intensive care • Signature of free and informed consent • Patient affiliated to a social security scheme, excluding AME (state medical aid) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 31 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 31
Exclusion criteria
Exclusion criteria: • Protected adult (under legal protection, under guardianship or curatorship) • Pregnancy or breast-feeding • Allergy to dexmedetomidine • Contraindication to a PET or MRI examination • Severe renal failure (creatinine clearance <30 ml / min) • Serious neurological history on admission to intensive care: o Stroke o Severe head trauma o Insane state with loss of autonomy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess whether treatment with dexmedetomidine upon removal of sedation to prevent or treat delirium in post-COVID-19 ARDS decreases persistent neuroinflammation measured by an increase in the radiotracer APD in the frontal lobes and detected at 'using PET-MRI performed 12 months (+/- 3 months) after discharge from intensive care.;Secondary Objective: To assess the association between the biological data, both immunological, transcriptomic and epigenomic, likely to promote or protect the persistence of a neuroinflammatory state at a distance from a severe infection with COVID-19 at 12 months (+/- 3 months) from the intensive care unit Identify the clinical and pharmacological risk factors (in particular the sedative treatments used for ventilatory weaning) for the occurrence of late neuroinflammation defined by an increase in APD on PET-MRI in the frontal lobes and in other regions of interest at 12 months (+/- 3 months) of discharge from intensive care;Primary end point(s): Persistent neuroinflammation is measured by the intensity of the [18F] -DPA-714 signal obtained by PET-MRI imaging at 12 months (+/- 3 months) after leaving the intensive care unit on the 2 frontal lobes (freesurfer segmentation, the intensity of the signal being the ratio of the measurement carried out in the frontal lobes to that carried out in the cerebellar lobes The standard fixation will be expressed as a value indexed with respect to the control value. The intensity of the [18F] -DPA-714 signal is the SUV (standard uptake value) or quantity of radioactivity fixed in the tissue which will be measured in each region of interest (frontal lobes and cerebellar lobes = reference) and related to the amount of radioactivity injected for examination. This signal will be corrected by taking into account the weight, the amount of radioactivity injected for the examination as well as the SNPrs6971 genotype (low, medium or high affinity of the radiotracer for its ligand). The ratio | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - To evaluate the effect of treatment with dexmedetomidine on acquired neuro-cognitive lesions using clinical evaluation scores at 12 months (+/- 3 months) of the discharge from intensive care of patients hospitalized for ARDS with COVID- 19; Neurocognitive injuries acquired using clinical assessment scores will be documented by: GOSE score (Glasgow outcome scale extended) 73 Rankin score74 presence of memory impairment assessed by the MOCA (Montreal cognitive assessment) score 75.76 and the GOAT (Galveston orientation amnesia test) 77 presence of a depressive state by the HADS (Hospital anxiety and depression scale) 78 dependencies by the Barthel score65.6 the presence of a PTSD (Post traumatic stress disorder) by the PTSD score the SF36 quality of life scale Qolibri scale (Quality of life after brain injury, quality of life scale after acute brain injury) GDS Scale (Geriatric Depression Scale) The detection of anorexia by the DSM-IV-TR and DSM-V scale in all patients of this cohort reviewed at 12 months of their discharge from intensive care for a COVID-19 ARDS during a consultation with a resuscitator as well a physician in physical medicine and rehabilitation and a neuropsychologist. - Evaluate the effect of dexmedetomidine treatment on neuro-cognitive lesions acquired with brain MRI diffusion tensor at 12 months (+/- 3 months) of the month of discharge from intensive care of patients hospitalized for ARDS due to COVID-19; Neurocognitive lesions acquired using a diffusion tensor brain MRI will be documented by: overall brain volume the brain volume of certain regions (corpus callosum, thalami, cerebrospinal fluid, cerebellum), an evaluation of white matter lesions (measurement of the anisotropy fraction (AF), mean diffusivity (MD), L1 and Lt) and this also at the level of the overall brain and in specific regions. - Evaluate the association between the biological data both immunological, transcriptomic and epigenomic likely to promote or | — |
Countries
France
Contacts
Public ContactPôle promotion
Assistance Publique – Hôpitaux de Paris
Outcome results
None listed