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Clinical Characteristics and Outcomes of Patients With COVID-19 on Mechanical Ventilation in Argentina (SATICOVID19)

12. november 2020 oppdatert av: Elisa Estenssoro, Argentinian Intensive Care Society

Clinical Characteristics and Outcomes of Patients With COVID-19 on Mechanical Ventilation in Argentina: a Prospective, Multicenter Cohort Study

The main objective of the present study is to determine ICU and in-hospital mortality associated with COVID-19 infection and its independent predictors, in patients admitted to adult ICUs in Argentina with a requirement for mechanical ventilation.

Secondary objectives include: determining epidemiological and clinical data in patients with COVID-19 disease; the associated morbidity, the support and therapeutic measures implemented, and the evolution of these patients upon discharge from the ICU.

Likewise, characteristics of each ICU will be recorded, and a survey will be carried out on the management of the COVID-19 pandemic, which will require information on the additional availability of critical resources for the care of patients admitted to the ICU. Likewise, characteristics of the ICU and hospitals will be registered.

Studieoversikt

Detaljert beskrivelse

In December 2019, China reported cases of acute respiratory disease caused by a new beta-coronavirus (SARS-CoV-2), called COVID-19 by the WHO. In January 2020 this entity issues an alert about the emergence of this new disease throughout the world, and in March it declares it a pandemic. Severe cases represent around 14-20% of those reported, and admission to the ICU is highly variable according to the different publications and severity of disease, ranging between 29% and 89%. The mortality reported in these publications ranges between 1.4 and 42%; with the development of acute respiratory distress syndrome (ARDS) being one of the most severe complications, associated with worst outcomes. However, the time of appearance of symptoms of severe acute respiratory failure has shown significant variability between these studies, with a median appearance of 2, 5 and 14 days from the onset of symptoms of the disease.

As of March 21, 2020, cases in Latin America were increasing, finding countries such as Brazil, Chile, Ecuador, Peru and Argentina among the countries with the highest number of confirmed cases, being classified as countries with local transmission. Since there is no information about on the behavior of this new disease in our country, the Argentine Society of Intensive Care (SATI) launched an epidemiological study to know the characteristics, risk factors and evolution of the most severely compromised patients with COVID-19, those admitted to the ICU requiring mechanical ventilation (MV).

Therefore, the main objective of the present study is to determine the ICU and in-hospital mortality associated with COVID-19 infection and its independent predictors, in patients admitted to adult ICUs in Argentina on MV.

Secondary objectives include: determining epidemiological and clinical data and mechanical ventilation management in patients with COVID-19 , support and therapeutic measures implemented by their assistant physicians, and the evolution and complications developed by these patients during their ICU stay. The different causes of death will also be recorded.

Likewise, characteristics of each ICU will be recorded, and a survey will be carried out on the management of the COVID-19 pandemic, which will require information on the additional availability of critical resources for the care of patients admitted to the ICU. The opinion about the management of the pandemic by the different governmental strata will be required, in order to detect possible points of improvement in the external management of the pandemic.

Studietype

Observasjonsmessig

Registrering (Faktiske)

950

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

    • BA
      • La Plata, BA, Argentina, 1900
        • Hospital Interzonal General de Agudos Gral. San Martín
      • san Isidro, BA, Argentina
        • Sanatorio Las Lomas
    • Caba
      • Buenos Aires, Caba, Argentina
        • Hospital General de Agudos Juan A. Fernández
      • Buenos Aires, Caba, Argentina
        • Sanatorio Anchorena Recoleta
    • Ciudad Autonoma De Buenos Aires
      • Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina
        • Sanatorio Otamendi

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

18 år og eldre (Voksen, Eldre voksen)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Prøvetakingsmetode

Ikke-sannsynlighetsprøve

Studiepopulasjon

Confirmed case:

Any suspected or probable case that presents positive results by rtPCR for SARS CoV-2.

Beskrivelse

Inclusion Criteria:

- Consecutive adult patients admitted to participating ICUs who require mechanical ventilation and present confirmed COVID-19 .

Exclusion Criteria:

  • Patients with severe respiratory infections / pneumonia due to another proven etiology.

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
Adult, patients with COVID-19 admitted to the ICU requiring mechanical ventilation

This is a prospective cohort study including patients >18 years RT-PCR positive for SARS Cov-2 admitted to the ICU that require mechanical ventilation. Epidemiological data, comorbidities, previous signs of symptoms of COVID-19. On admission, severity of disease scores, laboratory management data, blood gases and acid-base chemistry,respiratory and mechanical ventilation management,and complications (Development of ARDS, septic shock, acute kidney injury, thromboembolic events, infections and septic shock, will be recorded. If patients die, causes of death will be recorded.Treatments administered by attending physicians will be registered.

Dates of hospital and ICU admission, of death and/or discharge will be recorded.

No intervention will be administered. Follow-up will continue until death or ICU/hospital discharge

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
ICU Mortality
Tidsramme: From inclusion up to 90 days.
Refers to patients dying during their stay at the ICU, whatever the cause
From inclusion up to 90 days.

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Hospital mortality
Tidsramme: From date of inclusion to date of death from any cause, assessed up to 90 days
Refers to patients dying in the hospital, whatever the cause, after ICU discharge
From date of inclusion to date of death from any cause, assessed up to 90 days

Andre resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Independent predictors of mortality
Tidsramme: Through study completion, up to 90 days
Variables independently associated with mortality, according to multivariable analysis
Through study completion, up to 90 days
Length of invasive mechanical ventilation
Tidsramme: From date of intubation day to date of definitive weaning (more than 48 hours without the need of mechanical ventilation)
Days on invasive mechanical ventilation
From date of intubation day to date of definitive weaning (more than 48 hours without the need of mechanical ventilation)

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Etterforskere

  • Studiestol: Elisa Estenssoro, MD, Hospital Interzonal de Agudos San Martin de La Plata

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

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)

20. mars 2020

Primær fullføring (Faktiske)

31. oktober 2020

Studiet fullført (Faktiske)

31. oktober 2020

Datoer for studieregistrering

Først innsendt

29. oktober 2020

Først innsendt som oppfylte QC-kriteriene

29. oktober 2020

Først lagt ut (Faktiske)

2. november 2020

Oppdateringer av studieposter

Sist oppdatering lagt ut (Faktiske)

13. november 2020

Siste oppdatering sendt inn som oppfylte QC-kriteriene

12. november 2020

Sist bekreftet

1. november 2020

Mer informasjon

Begreper knyttet til denne studien

Plan for individuelle deltakerdata (IPD)

Planlegger du å dele individuelle deltakerdata (IPD)?

JA

IPD-planbeskrivelse

Data on duration of mechanical ventilation, ICU and Hospital stay will be shared

IPD-delingstidsramme

Data from patients included from April 30 to August 1, 2020, will be shared between October 1 and December 2020

Tilgangskriterier for IPD-deling

Data needed to perform mathematical models about duration of mechanical ventilation and ICU and hospital stay

IPD-deling Støtteinformasjonstype

  • CSR

Legemiddel- og utstyrsinformasjon, studiedokumenter

Studerer et amerikansk FDA-regulert medikamentprodukt

Nei

Studerer et amerikansk FDA-regulert enhetsprodukt

Nei

Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .

Kliniske studier på Covid-19

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