Actively Recruiting
Impact of Sedation After COVID-19 ARDS on Persistent Brain Inflammation An Observational Study Using PET-MRI to Assess Neuroinflammation and Cognitive Effects
Led by Assistance Publique - Hôpitaux de Paris · Updated on 2024-12-24
72
Participants Needed
1
Research Sites
202 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the impact of sedation with dexmedetomidine on ongoing brain inflammation in adults who survived severe COVID-19 that caused acute respiratory distress syndrome (ARDS) requiring intensive care. The study focuses on patients who required mechanical ventilation and deep sedation and explores the possible role of neuroinflammation in delirium during ventilator weaning and in long-term cognitive problems. Neuroinflammation is considered a key mechanism causing delirium, which can lead to serious complications and cognitive decline in many survivors. The study compares two groups of patients: those who were given dexmedetomidine for at least 24 hours during their ICU stay and those who were not exposed to this drug. Brain inflammation will be assessed using PET-MRI scans with the radiotracer [18F]-DPA-714, which measures microglial activation, at 24 months after ICU discharge, with an additional 24-month follow-up. Blood tests will also be performed to analyze inflammatory markers and immune cells using advanced techniques, aiming to understand the systemic and brain inflammatory profile. Participants will undergo imaging and blood sampling to measure brain inflammation and immune responses. The main outcome is the brain PET scan measurement of inflammation in frontal versus cerebellar lobes at 24 months post-ICU. Patients will also be monitored for cognitive effects and related changes. The study requires patients to have survived 24 months after ICU discharge and be between 18 and 74 years old. Informed consent and affiliation with the French social security system are required for participation.
CONDITIONS
Official Title
Impact of Post-ARDS Covid-19 Sedation on Persistent Neuroinflammation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult patient aged 18 to 74 years at the time of inclusion
- Confirmed COVID-19 infection by PCR test from nasopharyngeal or bronchoalveolar sample
- High or intermediate affinity TPSO genotype for [18F]-DPA-714
- Hospitalized in intensive care for ARDS after COVID-19 requiring mechanical ventilation and deep sedation for at least 24 hours
- Alive at 24 months (+ 24 months) after intensive care discharge
- Signed informed consent
- Affiliated to a National French social security system (excluding French State Medical Aid)
- For dexmedetomidine group: received dexmedetomidine for at least 24 hours during ICU stay
- For non-dexmedetomidine group: did not receive dexmedetomidine during ICU stay
You will not qualify if you...
- Under legal protection, guardianship, or curatorship
- Pregnant or breastfeeding
- Contraindication to PET or MRI examination
- Severe kidney impairment (creatinine clearance less than 30 mL/min)
- Contraindication to the radiopharmaceutical agent [18F]-DPA-714
- Serious neurological history at ICU admission including stroke, severe head trauma, or dementia with loss of autonomy
AI-Screening
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Trial Site Locations
Total: 1 location
1
Anesthesy department - Hôpital Pitié Salpêtrière
Paris, France, 75013
Actively Recruiting
Research Team
V
Vincent DEGOS, Pr
L
Laurence JALIN, Dr
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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