Comparative Analysis of Clinical Parameters and Radiographic Changes of Severe COVID-19
7 de junho de 2021 atualizado por: Second Affiliated Hospital, School of Medicine, Zhejiang University
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.
Visão geral do estudo
Status
Ativo, não recrutando
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Observacional
Inscrição (Antecipado)
80
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
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Zhejiang
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Hangzhou, Zhejiang, China, 310009
- Neuroscience care unit, Second Affiliated Hospital, School of Medicine, Zhejiang University
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
34 anos a 92 anos (Adulto, Adulto mais velho)
Aceita Voluntários Saudáveis
Não
Gêneros Elegíveis para o Estudo
Tudo
Método de amostragem
Amostra Não Probabilística
População do estudo
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
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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.
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Investigadores
- Diretor de estudo: Weilin Wang, Professor, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
1 de maio de 2020
Conclusão Primária (Real)
1 de maio de 2021
Conclusão do estudo (Antecipado)
1 de maio de 2022
Datas de inscrição no estudo
Enviado pela primeira vez
1 de junho de 2021
Enviado pela primeira vez que atendeu aos critérios de CQ
7 de junho de 2021
Primeira postagem (Real)
9 de junho de 2021
Atualizações de registro de estudo
Última Atualização Postada (Real)
9 de junho de 2021
Última atualização enviada que atendeu aos critérios de controle de qualidade
7 de junho de 2021
Última verificação
1 de maio de 2021
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- xp2020-355
Plano para dados de participantes individuais (IPD)
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INDECISO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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