Denne side blev automatisk oversat, og nøjagtigheden af ​​oversættelsen er ikke garanteret. Der henvises til engelsk version for en kildetekst.

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

12. november 2020 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Detaljeret 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.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

950

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

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

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
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

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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)

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Efterforskere

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

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

20. marts 2020

Primær færdiggørelse (Faktiske)

31. oktober 2020

Studieafslutning (Faktiske)

31. oktober 2020

Datoer for studieregistrering

Først indsendt

29. oktober 2020

Først indsendt, der opfyldte QC-kriterier

29. oktober 2020

Først opslået (Faktiske)

2. november 2020

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

13. november 2020

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. november 2020

Sidst verificeret

1. november 2020

Mere information

Begreber relateret til denne undersøgelse

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (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

IPD-delingsadgangskriterier

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

IPD-deling Understøttende informationstype

  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ingen

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

Kliniske forsøg med Covid-19

3
Abonner