Comparative Analysis of Clinical Parameters and Radiographic Changes of Severe COVID-19
7 juni 2021 bijgewerkt door: 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.
Studie Overzicht
Toestand
Actief, niet wervend
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Observationeel
Inschrijving (Verwacht)
80
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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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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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
34 jaar tot 92 jaar (Volwassen, Oudere volwassene)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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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.
Tijdsspanne: 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.
Tijdsspanne: up to 6 weeks
|
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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Onderzoekers
- Studie directeur: Weilin Wang, Professor, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start (Werkelijk)
1 mei 2020
Primaire voltooiing (Werkelijk)
1 mei 2021
Studie voltooiing (Verwacht)
1 mei 2022
Studieregistratiedata
Eerst ingediend
1 juni 2021
Eerst ingediend dat voldeed aan de QC-criteria
7 juni 2021
Eerst geplaatst (Werkelijk)
9 juni 2021
Updates van studierecords
Laatste update geplaatst (Werkelijk)
9 juni 2021
Laatste update ingediend die voldeed aan QC-criteria
7 juni 2021
Laatst geverifieerd
1 mei 2021
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- xp2020-355
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
ONBESLIST
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Nee
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
Nee
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