Status:
RECRUITING
Impact of Post-ARDS Covid-19 Sedation on Persistent Neuroinflammation
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Severe COVID-19
Eligibility:
All Genders
18-74 years
Brief 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 develop...
Detailed Description
COVID-19 is responsible of a pandemic since December 31 2019, which began in China and spread rapidly. Confirmed Covid positive patients worlwide is estimated at 179 M in June 2021. The infection star...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 21 2022
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 4 2026
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT05233605
Start Date
March 21 2022
End Date
February 4 2026
Last Update
December 24 2024
Active Locations (1)
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1
Anesthesy department - Hôpital Pitié Salpêtrière
Paris, France, 75013