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

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ClinicalTrials.gov Identifier: NCT04611269
Recruitment Status : Completed
First Posted : November 2, 2020
Last Update Posted : November 13, 2020
Sponsor:
Information provided by (Responsible Party):
Elisa Estenssoro, Argentinian Intensive Care Society

Tracking Information
First Submitted Date October 29, 2020
First Posted Date November 2, 2020
Last Update Posted Date November 13, 2020
Actual Study Start Date March 20, 2020
Actual Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: October 29, 2020)
ICU Mortality [ Time Frame: From inclusion up to 90 days. ]
Refers to patients dying during their stay at the ICU, whatever the cause
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: October 29, 2020)
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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 29, 2020)
  • Independent predictors of mortality [ Time Frame: Through study completion, up to 90 days ]
    Variables independently associated with mortality, according to multivariable analysis
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title 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
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 Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 9 Months
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population

Confirmed case:

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

Condition
  • Respiratory Failure
  • Covid-19
  • Mechanical Ventilation
Intervention Not Provided
Study Groups/Cohorts 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

Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 12, 2020)
950
Original Estimated Enrollment
 (submitted: October 29, 2020)
800
Actual Study Completion Date October 31, 2020
Actual Primary Completion Date October 31, 2020   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Argentina
Removed Location Countries  
 
Administrative Information
NCT Number NCT04611269
Other Study ID Numbers SATI
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: Data on duration of mechanical ventilation, ICU and Hospital stay will be shared
Supporting Materials: Clinical Study Report (CSR)
Time Frame: Data from patients included from April 30 to August 1, 2020, will be shared between October 1 and December 2020
Access Criteria: Data needed to perform mathematical models about duration of mechanical ventilation and ICU and hospital stay
Responsible Party Elisa Estenssoro, Argentinian Intensive Care Society
Study Sponsor Argentinian Intensive Care Society
Collaborators Not Provided
Investigators
Study Chair: Elisa Estenssoro, MD Hospital Interzonal de Agudos San Martin de La Plata
PRS Account Argentinian Intensive Care Society
Verification Date November 2020