Clinical characteristics and outcomes of patients with COVID-19 on mechanical ventilation in Argentina
| ISRCTN | ISRCTN78284710 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN78284710 |
| ClinicalTrials.gov number | NCT04611269 |
| Secondary identifying numbers | 01 |
- Submission date
- 10/02/2021
- Registration date
- 03/03/2021
- Last edited
- 28/06/2022
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Infections and Infestations
Plain English summary of protocol
Background and study aims
COVID-19 is a condition caused by the coronavirus (called SARS-CoV-2) that was first identified in late 2019. This virus can infect the respiratory (breathing) system. Some people do not have symptoms but can carry the virus and pass it on to others. People who have developed the condition may develop a fever and/or a continuous cough among other symptoms. This can develop into pneumonia. Pneumonia is a chest infection where the small air pockets of the lungs, called alveoli, fill with liquid and make it more difficult to breathe.
Groups who are at a higher risk from infection with the virus, and therefore of developing COVID-19, include people aged over 70 years, people who have long-term health conditions (such as asthma or diabetes), people who have a weakened immune system and people who are pregnant. People in these groups, and people who might come into contact with them, can reduce this risk by following the up-to-date advice to reduce the spread of the virus.
Knowledge about the epidemiology, management and outcomes of COVID-19 patients on invasive mechanical ventilation in low and middle income countries (LMICs) is scarce and fragmented. The aim of this study is to describe the practice of mechanical ventilation in patients with COVID-19 in Argentina.
Who can participate?
Patients older than 18 years with COVID-19 admitted to the Intensive Care Unit and requiring mechanical ventilation
What does the study involve?
The study involves the collection of epidemiological variables, mechanical ventilation variables, certain treatments applied and complications, and identification of independent prognostic (predictive) factors of mortality (death). The main outcome variable is hospital mortality; secondary outcomes are 28-day mortality, duration of mechanical ventilation, and duration of ICU and hospital stays.
What are the possible benefits and risks of participating?
Since this is an observational study, patients are not exposed to any risk or benefit. Anonymization of patient data is performed by assigning numeric codes. When finished and published, the main findings and conclusions might help to guide the management of COVID-19 and eventually improve healthcare management in future waves of the pandemic.
Where is the study run from?
1. Hospital Interzonal de Agudos San Martin de La Plata (Argentina)
2. Argentine Society of Intensive Care Medicine (SATI) (Argentina)
When is the study starting and how long is it expected to run for?
March 2020 to January 2021
Who is funding the study?
Investigator initiated and funded
Who is the main contact?
1. Elisa Estenssoro, MD
estenssoro.elisa@gmail.com
2. Fernando G. Ríos, MD
fernandrios@gmail.com
Contact information
Public
Street 42 number 577
La Plata
1900
Argentina
| Phone | +54 (0)22196073261 |
|---|---|
| estenssoro.elisa@gmail.com |
Public
Marcos paz 684
Moron
1707
Argentina
| Phone | +54 (0)1133796777 |
|---|---|
| fernandrios@gmail.com |
Study information
| Study design | Prospective cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | No participant information sheet available |
| Scientific title | Clinical characteristics and outcomes of patients with COVID-19 on mechanical ventilation in Argentina: a prospective, multicenter cohort study |
| Study acronym | SATICOVID19 |
| Study objectives | 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. |
| Ethics approval(s) | Approved 02/04/2020, Comité De Ética en Investigación Hospital San Martin De La Plata (CEI-HSMLP, Postal address: 1900; +54 (0)92216073261; ceihsmlaplata@gmail.com), ref: HSMLP2020/0021 |
| Health condition(s) or problem(s) studied | COVID-19 (SARS-CoV-2 infection) |
| Intervention | Epidemiological data, comorbidities, previous signs or symptoms of COVID-19 are collected. 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, the cause 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. |
| Intervention type | Other |
| Primary outcome measure | Hospital mortality: death of a patient (categorical binary data, 1 = nonsurvivor; and 0 = survivor) occurring at any time and in any site during hospitalization |
| Secondary outcome measures | 1. 28-day mortality: death of a patient (categorical binary data, 1 = nonsurvivor; and 0 = survivor) occurring in any site of the hospital between hospital admission and day 28 2. Duration of mechanical ventilation: number of days of invasive mechanical ventilation measured as continuous data (in days), as the difference between the date of weaning from mechanical ventilation and the date of endotracheal intubation 3. Length of ICU stay: number of days measured as continuous data (in days), as the difference between the date of ICU discharge and the date of ICU admission 4. Length of hospital stay; number of days measured as continuous data (in days), as the difference between the date of hospital discharge and the date of hospital admission |
| Overall study start date | 20/03/2020 |
| Completion date | 10/01/2021 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1300 |
| Total final enrolment | 1909 |
| Key inclusion criteria | Consecutive adult patients admitted to participating ICUs who require mechanical ventilation and present confirmed COVID-19 |
| Key exclusion criteria | Patients with severe respiratory infections/pneumonia due to another proven etiology |
| Date of first enrolment | 30/03/2020 |
| Date of final enrolment | 31/10/2020 |
Locations
Countries of recruitment
- Argentina
Study participating centre
La Plata
1900
Argentina
Sponsor information
Research organisation
Niceto 4615
Ciudad Autonoma de Buenos Aires
C1414BEA
Argentina
| Phone | +54 (0)1147780571 |
|---|---|
| natalia@sati.org.ar | |
| Website | https://www.sati.org.ar/ |
Funders
Funder type
Other
No information available
Results and Publications
| Intention to publish date | 01/04/2021 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The data might be available for 1 year after the date of the study publication. This will require the consent of the six principal researchers, and the aim of the request and statistical plan should be provided. The data are already anonymized. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol file | version 1 | 01/04/2021 | No | No | |
| Protocol file | version 2 | 01/04/2021 | No | No | |
| Results article | 01/09/2021 | 28/06/2022 | Yes | No |
Additional files
Editorial Notes
28/06/2022: Publication reference added.
01/04/2021: Uploaded protocol (not peer reviewed).
12/02/2021: Trial's existence confirmed by the Comite Central de Investigación en la Salud Provinica de Buenos Aires.
