Immunomodulatory Profile of Dexmedetomidine Sedation in Patients Recovering After ARDS Covid-19
试验速览
- 阶段
- 不适用
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Change of inflammatory cytokines concentration (mmol / L) in Covid19 + patients from Baseline at 6 months
研究概览
简要总结
Covid-19 infection is due to SARS-CoV-2 member of the Coronavirus family represented by SARS- and MERS-CoVwith neuronal tropism capacity for the brainstem and thalami. Dexmedetomidine has(i) central antihypertensive (ii) sedative and (iii) neuroprotective properties and is often used during patient recovering after mechanical ventilation withdrawal.
Dexmedetomidine administration could change the immunomodulatory profile of Covid-19 patients and reduce inflammatory response.CAM-ICU scores and Blood samples from Covid-19 ICU patients will be collected at 4 different timepoints (before Dexmedetomidine administration, at D2, D7 and M6) to analyse the inflammatory profile with different approaches:i) chromatin accessibility, ii) transcriptome analysis, iii) inflammatory cytokines and chemokines levels.
详细描述
Coronaviruses (CoV) cause enteric and respiratory diseases. Most human CoVs, such as hCoV - 229E, OC43, NL63 and HKU1, cause mild respiratory disease, but the global spread of two previously well-knownCoVs: Severe Acute Respiratory Syndrome (SARS-CoV) and Middle East respiratory syndrome (MERS-CoV) has proven the lethal potential of human CoV.
While MERS-CoV is still not eliminated from the world, another highly pathogenic CoV, currently named SARS- CoV-2, started in December 2019 in Wuhan, in China. This new CoV caused a Chinese outbreak of severe pneumonia (coronavirus 2019 [COVID - 19]), and quickly spread to other countries.
Genomic analyzes show that SARS-CoV-2 shares a highly homological sequence with other beta-coronavirus (βCoV) as MERS-CoV and SARS-CoV.
Some work published in the 2000s has shown the presence of SARS-CoV viruses in neurons. Similarly, some experimental work has demonstrate that the MERS-COV5 and SARS-CoV6 viruses detected in the intra-nasal airways have an affinity for several brain regions such as brainstem or thalami. MERS-Cov viral particles have been found in several organs, including brain after injection of an inoculum in mice.
Several studies indicate that the brain region involved in this context is the brainstem.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient ≥ 18 years at time of inclusion
- •Hospitalized in intensive care unit (ICU)
- •Administration of dexmedetomidine scheduled for 7 days
- •Intubated/ventilated patient infected with SARS-CoV-2 (Covid-19 positive patient)
- •Patient affiliated to a social security system (French State medical aid excluded)
- •Hemoglobin level ≥ 9 g /dL
- •Patient or parent / close / trusted person having been informed about the study and having given informed consent (or inclusion procedure in an emergency situation)
排除标准
- •Protected major (under safeguardship, curatorship or guardianship)
- •Pregnancy or breastfeeding
- •Contra-indication to dexmedetomidine administration
研究组 & 干预措施
SARS-CoV-2 (Covid-19 positive)
Patients hospitalized in intensive care unit (ICU), infected with SARS-CoV-2
干预措施: Inflammatory cytokines and chemokines profiles of patients with dexmedetomidine administration (Other)
结局指标
主要结局
Change of inflammatory cytokines concentration (mmol / L) in Covid19 + patients from Baseline at 6 months
时间窗: Month6
次要结局
- Change of interrelationship between inflammation (cytokines levels) and ICU delirium in Covid19 + patient from Baseline at 6 months(Month6)
- Modification in inflammatory genes expressed (expressed / non expressed) in PBMC between Baseline and M6(Month6)
- Change in quantity of chromatine's openings (chromatin accessibility profiles) in ICU patient recovering from covid19 infection(Day2, Month6)
- Change in genes expression in Covid-19 patient with delirium in ICU between Day2 and Month6(Day2, Month6)