Comparative Analysis of Clinical Parameters and Radiographic Changes of Severe COVID-19
Comparative Analysis of Clinical Indicators and Imaging Changes of Severe COVID-19
調査の概要
詳細な説明
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.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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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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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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.
時間枠：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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協力者と研究者
捜査官
- スタディディレクター：Weilin Wang, Professor、2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (実際)
研究の完了 (予想される)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- xp2020-355
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
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