Impact of post-Acute respiratory distress syndrome COVID sedation on late neuroinflammation (PET-DEXDOCOVID)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Persistent neuroinflammation is measured by the intensity of the [18F]-DPA-714 signal obtained in PET-MRI imaging at 24 months (+24 months) after discharge from intensive care on the 2 frontal lobes (freesurfer segmentation, the signal intensity being the ratio of the measurement made in the frontal lobes to that made in the cerebellar lobes. Standard fixation will be expressed as an indexed value relative to the control value.
研究概览
简要总结
To evaluate whether treatment with dexmedetomidine at the end of sedation to prevent or treat delirium following post-COVID-19 ARDS reduces persistent neuroinflammation measured by an increase in the radio pharmaceutical DPA in the frontal lobes and detected using PET-MRI at 24 months (+24 months) after discharge from intensive care.
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 否
入选标准
- •Patients over the age of majority (age ≥ 18 years at the time of inclusion) and under 75 years of age
- •COVID-19 infection documented by nasopharyngeal PCR test.
- •TPSO genotyping homozygous high affinity for [18F]-DPA-714 or heterozygous intermediate affinity for [18F]-DPA-
- •Patient admitted to intensive care for ARDS following COVID infection requiring mechanical ventilation and deep sedation for at least 24 hours.
- •Patient alive 24 months (+24 months) after discharge from intensive care unit
- •Signature of free and informed consent
- •Patient affiliated to a social security scheme, excluding AME (state medical aid)
- •For the group of patients exposed to dexmedetomidine : - Administration of dexmedetomidine for at least 24 hours during hospitalisation in intensive care.
- •For the group of patients not exposed to dexmedetomidine : - No administration of dexmedetomidine during hospitalisation in the intensive care unit.
排除标准
- •Protected adults (under court protection, guardianship or curatorship)
- •Poor vaccine tolerance requiring hospitalisation
- •Pregnant or breast-feeding
- •Contraindication to a PET or MRI scan
- •Contraindication to the administration of the radiopharmaceutical [18F]-DPA-714
- •Severe renal insufficiency (creatinine clearance < 30 mL/min)
- •Serious neurological history on admission to the intensive care unit: o Cerebrovascular accident o Severe head trauma o Dementia with loss of autonomy
- •New severe COVID infection of the ARDS type
- •New severe bacterial infection of the severe sepsis type
- •Severe surgical traumatism such as cranial trauma or polytraumatism
结局指标
主要结局
Persistent neuroinflammation is measured by the intensity of the [18F]-DPA-714 signal obtained in PET-MRI imaging at 24 months (+24 months) after discharge from intensive care on the 2 frontal lobes (freesurfer segmentation, the signal intensity being the ratio of the measurement made in the frontal lobes to that made in the cerebellar lobes. Standard fixation will be expressed as an indexed value relative to the control value.
Persistent neuroinflammation is measured by the intensity of the [18F]-DPA-714 signal obtained in PET-MRI imaging at 24 months (+24 months) after discharge from intensive care on the 2 frontal lobes (freesurfer segmentation, the signal intensity being the ratio of the measurement made in the frontal lobes to that made in the cerebellar lobes. Standard fixation will be expressed as an indexed value relative to the control value.
The intensity of the [18F]-DPA-714 signal is the standard uptake value which will be measured in each region of interest (frontal lobes and cerebellar lobes = reference) and related to the quantity of radioactivity injected for the examination. The ratio of SUV in the frontal lobes to SUV in the cerebellar lobes will give us the radioligand uptake ratio for the area of interest.
The intensity of the [18F]-DPA-714 signal is the standard uptake value which will be measured in each region of interest (frontal lobes and cerebellar lobes = reference) and related to the quantity of radioactivity injected for the examination. The ratio of SUV in the frontal lobes to SUV in the cerebellar lobes will give us the radioligand uptake ratio for the area of interest.
次要结局
- - To evaluate the effect of dexmedetomidine treatment on acquired neurocognitive damage using clinical assessment scores at 24 months (+24 months) after discharge from intensive care of patients hospitalised for ARDS with COVID-19 ;
- - To evaluate the effect of dexmedetomidine treatment on neurocognitive lesions acquired with diffusion tensor brain MRI at 24 months (+24 months) after discharge from intensive care following COVID ARDS.
- - To assess the association between immunological, transcriptomic and epigenomic biological data likely to promote or protect against the persistence of a neuroinflammatory state remote from a severe COVID-19 infection 24 months (+24 months) after discharge from intensive care.
- - To 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 DPA on PET-MRI in the frontal lobes and other regions of interest at 24 months (+24 months) after discharge from intensive care
研究者
Coordinator investigator
Scientific
Assistance Publique Hopitaux De Paris