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

Completed

• Conditions: Covid-19; Respiratory Failure; Mechanical Ventilation

• Registration Number: NCT04611269
• Lead Sponsor: Argentinian Intensive Care Society

Brief Summary

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.

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 Timeline

• Study Start: 2020-03-20
• Study First Submitted: 2020-10-29
• Study First Submitted QC: 2020-10-29
• Primary Completion: 2020-10-31
• Study Completion: 2020-10-31
• Status Verified: 2020-11
• Study First Posted: 2020-11-02
• Last Update Submitted: 2020-11-12
• Last Update Posted: 2020-11-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 950

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
ICU Mortality	From inclusion up to 90 days.	Refers to patients dying during their stay at the ICU, whatever the cause

Secondary Outcome Measures

Name	Time	Method
Hospital mortality	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

Trial Locations

Locations (5)

Hospital Interzonal General de Agudos Gral. San Martín; 🇦🇷 La Plata, BA, Argentina

Sanatorio Anchorena Recoleta; 🇦🇷 Buenos Aires, Caba, Argentina

Sanatorio Las Lomas; 🇦🇷 san Isidro, BA, Argentina

Hospital General de Agudos Juan A. Fernández; 🇦🇷 Buenos Aires, Caba, Argentina

Sanatorio Otamendi; 🇦🇷 Buenos Aires, Ciudad Autonoma De Buenos Aires, Argentina