Comparative Analysis of Clinical Parameters and Radiographic Changes of Severe COVID-19
7. juni 2021 oppdatert av: 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.
Studieoversikt
Status
Aktiv, ikke rekrutterende
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Observasjonsmessig
Registrering (Forventet)
80
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Zhejiang
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Hangzhou, Zhejiang, Kina, 310009
- Neuroscience care unit, Second Affiliated Hospital, School of Medicine, Zhejiang University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
34 år til 92 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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.
Tidsramme: up to 6 weeks
|
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.
Tidsramme: 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
|
|
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.
Tidsramme: up to 6 weeks
|
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.
Tidsramme: 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.
Tidsramme: up to 6 weeks
|
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.
Tidsramme: 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.
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Studieleder: Weilin Wang, Professor, 2nd Affiliated Hospital, School of Medicine, Zhejiang University, China
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mai 2020
Primær fullføring (Faktiske)
1. mai 2021
Studiet fullført (Forventet)
1. mai 2022
Datoer for studieregistrering
Først innsendt
1. juni 2021
Først innsendt som oppfylte QC-kriteriene
7. juni 2021
Først lagt ut (Faktiske)
9. juni 2021
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
9. juni 2021
Siste oppdatering sendt inn som oppfylte QC-kriteriene
7. juni 2021
Sist bekreftet
1. mai 2021
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- xp2020-355
Plan for individuelle deltakerdata (IPD)
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