Clinical trial NCT04611269: Clinical Characteristics and Outcomes of Patients With COVID-19 on Mechanical Ventilation in Argentina
Official title: Clinical Characteristics and Outcomes of Patients With COVID-19 on Mechanical Ventilation in Argentina: a Prospective, Multicenter Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Respiratory Failure
Covid-19
Mechanical Ventilation
Lead sponsor: Argentinian Intensive Care Society
Sponsor class: OTHER
First posted: 2020-11-02
Enrollment: 950
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Confirmed case:

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

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.

Eligibility criteria: 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.

Primary outcomes:
measure: ICU Mortality
timeFrame: From inclusion up to 90 days.
Secondary outcomes:
measure: Hospital mortality
timeFrame: From date of inclusion to date of death from any cause, assessed up to 90 days
Other outcomes:
measure: Independent predictors of mortality
timeFrame: Through study completion, up to 90 days
measure: Length of invasive mechanical ventilation
timeFrame: From date of intubation day to date of definitive weaning (more than 48 hours without the need of mechanical ventilation)
Locations:
city: La Plata
country: Argentina
facility: Hospital Interzonal General de Agudos Gral. San Martín
state: BA
city: san Isidro
country: Argentina
facility: Sanatorio Las Lomas
state: BA
city: Buenos Aires
country: Argentina
facility: Hospital General de Agudos Juan A. Fernández
state: Caba
city: Buenos Aires
country: Argentina
facility: Sanatorio Anchorena Recoleta
state: Caba
city: Buenos Aires
country: Argentina
facility: Sanatorio Otamendi
state: Ciudad Autonoma De Buenos Aires
Study officials:
affiliation: Hospital Interzonal de Agudos San Martin de La Plata
name: Elisa Estenssoro, MD
role: STUDY_CHAIR
References:
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citation: Ferrando C, Suarez-Sipmann F, Mellado-Artigas R, Hernandez M, Gea A, Arruti E, Aldecoa C, Martinez-Palli G, Martinez-Gonzalez MA, Slutsky AS, Villar J; COVID-19 Spanish ICU Network. Clinical features, ventilatory management, and outcome of ARDS caused by COVID-19 are similar to other causes of ARDS. Intensive Care Med. 2020 Dec;46(12):2200-2211. doi: 10.1007/s00134-020-06192-2. Epub 2020 Jul 29.
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citation: Bouadma L, Lescure FX, Lucet JC, Yazdanpanah Y, Timsit JF. Severe SARS-CoV-2 infections: practical considerations and management strategy for intensivists. Intensive Care Med. 2020 Apr;46(4):579-582. doi: 10.1007/s00134-020-05967-x. Epub 2020 Feb 26. No abstract available.
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