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

12 de noviembre de 2020 actualizado por: 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.

Descripción general del estudio

Descripción detallada

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.

Tipo de estudio

De observación

Inscripción (Actual)

950

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • 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

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Confirmed case:

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

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

Cohortes e Intervenciones

Grupo / Cohorte
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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
ICU Mortality
Periodo de tiempo: 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.

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Hospital mortality
Periodo de tiempo: 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

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Independent predictors of mortality
Periodo de tiempo: 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
Periodo de tiempo: 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)

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Investigadores

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

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Publicaciones Generales

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

20 de marzo de 2020

Finalización primaria (Actual)

31 de octubre de 2020

Finalización del estudio (Actual)

31 de octubre de 2020

Fechas de registro del estudio

Enviado por primera vez

29 de octubre de 2020

Primero enviado que cumplió con los criterios de control de calidad

29 de octubre de 2020

Publicado por primera vez (Actual)

2 de noviembre de 2020

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

13 de noviembre de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

12 de noviembre de 2020

Última verificación

1 de noviembre de 2020

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan IPD

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

Marco de tiempo para compartir IPD

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

Criterios de acceso compartido de IPD

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

Tipo de información de apoyo para compartir IPD

  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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