Comparative Analysis of Clinical Parameters and Radiographic Changes of Severe COVID-19
Comparative Analysis of Clinical Indicators and Imaging Changes of Severe COVID-19
Novel Coronavirus Pneumonia (COVID-19) is the pneumonia caused by the 2019 novel coronavirus infection.
Critically ill patients with this disease develop dyspnea and hypoxemia, and even further aggravate acute respiratory distress syndrome, septic shock, coagulation dysfunction, and multiple organ failure.
Since February 15, 2020, the 171-member medical team of the Second Affiliated Hospital of Zhejiang University School of Medicine has taken over the Intensive Care Unit of the Cancer Center of the Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology and the Intensive Care Unit of the West Hospital of Union Hospital to carry out severe and critical care.
Treatment of patients with new coronary pneumonia.
In clinical practice, combined with the changes in chest CT imaging of severe COVID-19 patients, it has been found that some laboratory indicators of severe patients can effectively judge the clinical prognosis and outcome of patients, but there is no relevant retrospective study with large sample size so far.
研究概览
详细说明
Novel Coronavirus Pneumonia (COVID-19) is the pneumonia caused by the 2019 novel coronavirus infection. Critically ill patients with this disease develop dyspnea and hypoxemia, and even further aggravate acute respiratory distress syndrome, septic shock, coagulation dysfunction, and multiple organ failure. Since February 15, 2020, the 171-member medical team of the Second Affiliated Hospital of Zhejiang University School of Medicine has taken over the Intensive Care Unit of the Cancer Center of the Union Hospital Affiliated to Tongji Medical College of Huazhong University of Science and Technology and the Intensive Care Unit of the West Hospital of Union Hospital to carry out severe and critical care. Treatment of patients with new coronary pneumonia. In clinical practice, combined with the changes in chest CT imaging of severe COVID-19 patients, it has been found that some laboratory indicators of severe patients can effectively judge the clinical prognosis and outcome of patients, but there is no relevant retrospective study with large sample size so far.
In April 16, 2020, the investigators submitted the research project, comparative analysis of clinical parameters and radiographic changes of severe COVID-19, to human subject research ethics committee of Second Affiliated Hospital, School of Medicine, Zhejiang University. The research process began after the committee for approval in May 2020.
In this study, by comparing the changes in chest CT imaging of patients with severe COVID-19, the investigators analyzed the effects of some clinical indicators on the prognosis and outcome of patients.
研究类型
观察性的
注册 (预期的)
80
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Zhejiang
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Hangzhou、Zhejiang、中国、310009
- Neuroscience care unit, Second Affiliated Hospital, School of Medicine, Zhejiang University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
34年 至 92年 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
非概率样本
研究人群
Severe and critical COVID-19 patients admitted to the Intensive Care Unit of the Cancer Center of Union Hospital of Tongji Medical College of Huazhong University of Science and Technology and the Intensive Care Unit of West Hospital of Union Hospital
描述
Inclusion Criteria:
- COVID-19 patients who meet the criteria for confirmed cases in the "New Coronavirus Pneumonia Diagnosis and Treatment Plan (Trial Seventh Edition)";
- The clinical classification is severe and critical.
Exclusion Criteria:
- Patients who died within 72 hours of admission;
- Patients who cannot be transferred to chest CT imaging due to their medical conditions.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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Severe COVID-19
Comparative Analysis of Clinical Parameters and Radiographic Changes
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Non-severe and critically ill patients with COVID-19
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Lactic acid measurement in the blood gas results indirectly reflects the body's respiratory function, and it can also reflect the degree of metabolic acidosis in the body.
大体时间：up to 6 weeks
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Weekly monitoring of blood gas analysis in severe COVID-19 patients.
Lactic acid measurement in the blood gas results indirectly reflects the body's respiratory function, and it can also reflect the degree of metabolic acidosis in the body.
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up to 6 weeks
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The possibility of inflammatory response in patients with large lymphocytes COVID-19 levels were significantly reduced.
大体时间：up to 6 weeks
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Weekly monitoring of blood routine in severe COVID-19 patients.
The possibility of inflammatory response in patients with large lymphocytes COVID-19 levels were significantly reduced.
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up to 6 weeks
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C-reactive protein（CRP） rises rapidly, but the rise is moderate, which can be used as an auxiliary diagnostic index for sepsis after COVID-19.
大体时间：up to 6 weeks
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Weekly monitoring of C-reactive protein （CRP）in severe COVID-19 patients.
After the new coronavirus infection, CRP rises rapidly, but the increase is moderate, which is an auxiliary diagnostic index for sepsis.
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up to 6 weeks
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Procalcitonin（PCT) is a diagnostic indicator of bacterial sepsis after COVID-19.
大体时间：up to 6 weeks
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Weekly monitoring of procalcitonin in severe COVID-19 patients.
After the new coronavirus infection, PCT has high specificity, but the level does not increase or slightly increases, which is a diagnostic indicator of bacterial sepsis.
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up to 6 weeks
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The continuous decline of cluster of differentiation 4+ T cells(CD4+) and cluster of differentiation 8+ T cells (CD8+ ) should be alert to the deterioration of COVID-19.
大体时间：up to 6 weeks
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Weekly monitoring of CD4+/CD8+ in severe COVID-19 patients.
The continuous decline of CD4+ and CD8+ T cells should be alert to the deterioration of the disease.
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up to 6 weeks
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The progressive rise of interleukin-6 (IL-6) as a clinical warning indicator for the deterioration of COVID-19.
大体时间：up to 6 weeks
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Weekly monitoring of interleukin-6 in severe COVID-19 patients.
The level of IL-6 increase is consistent with the severity of the disease.
Once the disease is under control, it will drop rapidly; if it does not decrease rapidly after treatment, it often indicates a poor prognosis.
The notification of the diagnosis and treatment plan for severe and critical cases of new coronavirus pneumonia (the second version on trial) has clearly identified the progressive rise of IL-6 as a clinical warning indicator for the deterioration of the disease.
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up to 6 weeks
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Chest computer tomography (CT) can reflect the progress of the disease, and may have a certain prompting effect on the prognosis of COVID-19 patients.
大体时间：up to 6 weeks
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Weekly monitoring of chest CT imaging of patients with severe COVID-19.
COVID-19 is highly contagious, chest CT manifestations are diverse, with multiple ground glass shadows in both lungs with or without partial solidification as the main feature, mainly subpleural distribution, as the course of the disease progresses, CT manifestations gradually increase with the time of onset.
At the same time, CT semi-quantitative scores can reflect the progress of the disease, and may have a certain prompting effect on the prognosis of patients.
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up to 6 weeks
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：Weilin Wang, Professor、2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2020年5月1日
初级完成 (实际的)
2021年5月1日
研究完成 (预期的)
2022年5月1日
研究注册日期
首次提交
2021年6月1日
首先提交符合 QC 标准的
2021年6月7日
首次发布 (实际的)
2021年6月9日
研究记录更新
最后更新发布 (实际的)
2021年6月9日
上次提交的符合 QC 标准的更新
2021年6月7日
最后验证
2021年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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