Microvascular Injury With Secondary Edema, and Distal Peripheral Vascular Thrombosis Contribution to Clinical Deterioration of Non-critically Ill Patients Hospitalized for SARS-CoV-2 Pneumonia Without Evidence of Pulmonary Embolism: a Preliminary Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Pulmonary microvascular injury
研究概览
简要总结
Investigators aimed to better understand the pathophysiology of SARS-CoV-2 pneumonia in non-critically ill hospitalized patients secondarily presenting with clinical deterioration and increase in oxygen requirement
详细描述
Investigators plan to consecutively enrol 25 patients without clinical or biological evidence for superinfection, without left ventricular dysfunction and for whom a pulmonary embolism was discarded by computed tomography pulmonary angiography. Investigators will investigate lung ventilation and perfusion (LVP) by LVP scintigraphy, and, 24 hours later, left and right ventricular function by 99mTc-labelled albumin gated-blood-pool scintigraphy with late (60 mn) tomographic albumin images on the lungs to evaluate lung albumin retention that could indicate microvascular injuries with secondary edema
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
- •Non-critically ill patients hospitalized in the COVID-19 Unit of the Centre Hospitalier Princesse Grace of Monaco
- •Presenting with a sudden clinical deterioration defined by a respiratory rate impairment and/or a rise of oxygen flow to reach a peripheral capillary oxygen saturation (SpO2) of more than 95% during at least 48 hours
- •a diagnosis of pulmonary embolism was discarded by CT pulmonary angiography
- •no clinical or biological (procalcitonin levels) evidence of lung superinfection
- •without clinical evidence for LV dysfunction
排除标准
- •Non confirmed COVID-19 pneumonia according to the WHO guidance by a positive result of RT-PCR assay of nasal and pharyngeal swabs,
- •Patients without peripheral pulmonary ground-glass opacities or air-space consolidation on their chest CT scan at admission and common laboratory findings including lymphocytopenia, eosinopenia, significantly elevated markers of organ inflammation such as fibrinogen and C-reactive protein.
- •Patients could not be included if their medical condition was unstable or precluded a safe transfer to the nuclear medicine department, if they were under mechanical ventilation (either non-invasive or invasive), if they required critical care unit, or in case of a pregnancy.
结局指标
主要结局
Pulmonary microvascular injury
时间窗: During hospitalization
Determination of the number of patients/pulmonary segments with evidence for microvascular injury on the basis of a lung 99mTc albumin retention, calculated as albumin uptake normalized by the macro-aggregates perfusion uptake
Scintigraphic pattern of peripheral lung thrombosis
时间窗: During hospitalization
Determination of the number of patients/pulmonary segments with scintigraphic pattern of peripheral lung thrombosis on the basis of a mismatch between normal ventilation and abnormal perfusion
次要结局
- Prognosis evolution at 15 days(15 days after hospitalization)
- CT abnormalities prognostic value(15 days after hospitalization)