Effects of sedation on neuroinflammation in COVID-19 patients
Impact of Post-ARDS Covid Sedation on Persistent Neuroinflammation (PET-DEXDOCOVID)
This study looks at whether using a specific sedative can help reduce brain inflammation and improve recovery for COVID-19 patients on ventilators.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 72 (estimated) |
| Ages | 18 Years to 74 Years |
| Sex | All |
| Sponsor | Assistance Publique - Hôpitaux de Paris Academic / other |
| Locations | 1 site (Paris) |
| Trial ID | NCT05233605 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the impact of sedation on neuroinflammation in patients who have experienced acute respiratory distress syndrome (ARDS) due to COVID-19. It focuses on ICU patients who require mechanical ventilation and examines the role of dexmedetomidine, a sedative with potential neuroprotective effects, in reducing neuroinflammation and associated cognitive complications. The study aims to understand how sedation practices can influence the recovery and cognitive outcomes of these patients after they are weaned from mechanical ventilation.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who have been hospitalized for ARDS due to COVID-19 and required mechanical ventilation.
Not a fit: Patients who are not hospitalized for ARDS or those who have not received mechanical ventilation may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved cognitive outcomes and reduced complications for patients recovering from severe COVID-19.
How similar studies have performed: While the specific approach of this study may be novel, there is emerging literature suggesting that neuroinflammation plays a significant role in cognitive outcomes post-ARDS, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Paris
- Anesthesy department - Hôpital Pitié Salpêtrière — Paris, France (Recruiting)
Study contacts
- Study coordinator: Vincent DEGOS, Pr
- Email: vincent.degos@aphp.fr
- Phone: (0)1 42 16 37 61
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.