Pathological Findings in Critically-ill Patients Who Died From SARS-CoV-2 Related Acute Respiratory Distress Syndrome
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 170
- 试验地点
- 44
- 主要终点
- Analysis of the pathological findings of a large cohort of patients who died from COVID-19 in the ICU
研究概览
简要总结
The Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) is a new coronavirus discovered in December 2019 in Wuhan, China and currently responsible of a worldwide outbreak and the death of more than 55,000 patients in France. The more severe form of COVID-19 disease induces a pneumonia with profound hypoxemia which may require invasive mechanical ventilation. It is estimated that 5% of COVID-19 patients are admitted to the Intensive Care Unit (ICU) for management. Hospital mortality in patients who develop severe acute respiratory distress syndrome (ARDS) ranges between 40% and 60%. The investigators purpose to investigate the pathological findings of COVID-19 patients who died from ARDS in the ICU by doing post-mortem lung biopsies
详细描述
Forty-four French ICUs participate to this study with the aim to perform 200 lung biopsies in 100 patients over a 12-month period. This cohort will be the largest pathological database of COVID-19 patients who developed ARDS. In accordance with the French law, this study has been approved and registered by the French Agency of Biomedicine and the French Ministry of Education and Research (#PFS 20-016). Two transcutaneous lung biopsies per patient will be performed using a 14G needle and anatomical landmarks (1 anterior biopsy and 1 posterior biopsy). All biopsies will be referred to the Department of Pathology of Nantes university hospital and analysed by a group of pathologists specialized in lung tissue. The primary objective is to describe and characterize the lesions of the lung induced by the SARS-CoV-2 infection. The secondary objectives are to correlate the pathological findings with the patients' demographics, the treatments administered during the ICU stay, the ventilator settings, to document the percentage of co-infections and their types, compare the radiographic findings (Chest X-ray and CT-scan of the chest) with the pathological findings, to compare the pathological findings of early deaths (<1week after ICU admission) versus late deaths (>1 week). These pathological findings will undoubtedly help to better understand the pathophysiology of SARS-CoV-2 pneumonia and pave the way to the development of new therapeutic strategies
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Adult patients (Age≥18 years-old)
- •Hospitalized in Intensive Care Unit (ICU)
- •Dead in the ICU from documented Covid-19 (clinical and radiological signs of pneumonia with a positive SARS-Cov-2 PCR from the upper or lower respiratory tract)
- •Not registered in the national register of refusal of the French Biomedicine Agency
- •According to French law, there was no requirement for signed consent, but the patient's next of kin were informed about the study before enrolment and were given a letter of information about the study.
排除标准
- •Covid-19 not documented by a positive SARS-Cov-2 PCR
- •Patient with a positive SARS-Cov-2 PCR but without any signs of pneumonia during the ICU stay (no clinical and no radiological signs of pneumonia)
- •Patient registered in the "national register of refusal" of the French Biomedicine Agency
- •Refusal expressed by the patient's next of kin to participate to the study
结局指标
主要结局
Analysis of the pathological findings of a large cohort of patients who died from COVID-19 in the ICU
时间窗: Two post-mortem lung biopsies performed immediately after death.
Detailed description and analysis of the primary lesions of the lungs in patients who died in the ICU from Covid-19.
次要结局
- Comparison between early (<1 week after ICU admission) and late (≥1 week) deaths(Two post-mortem lung biopsies performed immediately after death.)
- Analysis of the influence of ARDS severity and length on pathological findings(Two post-mortem lung biopsies performed immediately after death.)
- Analysis of the influence of pharmacological treatments (steroids) on pathological findings(Two post-mortem lung biopsies performed immediately after death.)
- Association between the primary cause of death and pathological findings(Two post-mortem lung biopsies performed immediately after death.)
- Analysis of the correlation between radiological findings and pathological findings(Two post-mortem lung biopsies performed immediately after death.)
- Analysis of the correlation between the ventilator settings and pathological findings(Two post-mortem lung biopsies performed immediately after death.)
- Co-infections(Two post-mortem lung biopsies performed immediately after death.)