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

November 12, 2020 updated by: 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.

Study Overview

Status

Completed

Conditions

Detailed Description

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.

Study Type

Observational

Enrollment (Actual)

950

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
    • 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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Confirmed case:

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ICU Mortality
Time Frame: 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.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Hospital mortality
Time Frame: 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

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Independent predictors of mortality
Time Frame: 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
Time Frame: 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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Argentinian Intensive Care Society

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 20, 2020

Primary Completion (Actual)

October 31, 2020

Study Completion (Actual)

October 31, 2020

Study Registration Dates

First Submitted

October 29, 2020

First Submitted That Met QC Criteria

October 29, 2020

First Posted (Actual)

November 2, 2020

Study Record Updates

Last Update Posted (Actual)

November 13, 2020

Last Update Submitted That Met QC Criteria

November 12, 2020

Last Verified

November 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SATI

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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

IPD Sharing Time Frame

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

IPD Sharing Access Criteria

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

IPD Sharing Supporting Information Type

  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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