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 (NCT)	NCT04611269
Clinical Trials Information System (CTIS)	Nil known
Protocol serial number	01
Sponsor	Sociedad Argentina de Terapia Intensiva (SATI)
Funder	Investigator initiated and funded

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

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

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

Dr Elisa Estenssoro
Public

Street 42 number 577
La Plata
1900
Argentina

Phone	+54 (0)22196073261
Email	estenssoro.elisa@gmail.com

Dr Fernando Rios
Public

Marcos paz 684
Moron
1707
Argentina

Phone	+54 (0)1133796777
Email	fernandrios@gmail.com

Study information

Primary study design	Observational
Study design	Prospective cohort study
Secondary study design	Cohort study
Study type	Participant information sheet
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(s)	Hospital mortality: death of a patient (categorical binary data, 1 = nonsurvivor; and 0 = survivor) occurring at any time and in any site during hospitalization
Key secondary outcome measure(s)	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
Completion date	10/01/2021

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	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

Hospital Interzonal de Agudos, Gral san Martin de la Plata

Avenida 1 y 70
La Plata
1900
Argentina

Results and Publications

Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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?
Results article		01/09/2021	28/06/2022	Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Protocol file	version 1		01/04/2021	No	No
Protocol file	version 2		01/04/2021	No	No

Additional files

ISRCTN78284710_PROTOCOL.pdf: Protocol file
ISRCTN78284710_PROTOCOL2.pdf: Protocol file

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.