Clinical trial NCT04336345: Outcomes of Patients With COVID-19 in the Intensive Care Unit
Official title: Outcomes of Patients With COVID-19 in the Intensive Care Unit: A National Observational Study (Mexico COVID-19 ICU Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Coronavirus Infections
COVID-19
Viral Pneumonia Human Coronavirus
Keywords: Intensive care unit
Critical care
Outcomes
Epidemiology
Lead sponsor: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Sponsor class: OTHER
First posted: 2020-04-07
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Critically ill patients aged over 18 years with a positive for SARS-CoV-2 result required admission to an intensive care unit or critical care in other areas of the hospital (critical care surge capacity).

Brief summary: The objective of this study is to evaluate the clinical characteristics and outcomes of critically ill patients with COVID-19 admitted to the intensive care unit.

A Multicenter Observational Study.

Detailed description: As of 23 March 2020, a cumulative total of 332,930 confirmed cases of coronavirus disease 2019 (COVID-19) were reported in 189 countries and territories worldwide. As of this time, there had been 367 total confirmed cases of COVID-19, including four deaths in Mexico. The clinical manifestations of patients with COVID-19 are wide, asymptomatic infection, mild upper respiratory tract illness, and approximately 5% of critically ill patients with COVID-19 have presented rapidly progressive respiratory failure, development of acute respiratory distress syndrome (ARDS), and intensive care unit (ICU) admission. On March 24, 2020, the Secretary of Health of Mexico, formally declared the beginning of phase 2. It has been estimated that many confirmed cases of COVID-19 would occur, thus would result in a significant increase of hospital and ICU admissions.

Eligibility criteria: Inclusion Criteria:

* Confirmed case: Critically ill patient who meets the operational definition of a suspected case and who has a confirmed diagnosis by the National Network of Public Health Laboratories recognized by the Institute of Epidemiological Diagnosis and Reference (Indre) (Mexico).

Exclusion Criteria:

* If a negative for SARS-CoV-2 result is obtained from a critically ill patient with a high index of suspicion for COVID-19 virus infection.
* Patients who had participated in another observational study in the last 30 days prior to inclusion.

Primary outcomes:
measure: Hospital mortality
timeFrame: 30 days
Secondary outcomes:
measure: Length of stay in the intensive care unit
timeFrame: Through study completion, an average of 30 days
Other outcomes:
Locations:
city: Mexico City
country: Mexico
facility: Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán
city: Mexico
country: Mexico
facility: All centres from Mexico willing to contribute are Welcome.
Study officials:
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Silvio A. Ñamendys-Silva, MD, MSc
role: PRINCIPAL_INVESTIGATOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Guillermo Dominguez-Cherit, MD
role: STUDY_DIRECTOR
affiliation: Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
name: Eduardo Rivero-Sigarroa, MD
role: STUDY_CHAIR
References:
citation: Namendys-Silva SA, Alvarado-Avila PE, Dominguez-Cherit G, Rivero-Sigarroa E, Sanchez-Hurtado LA, Gutierrez-Villasenor A, Romero-Gonzalez JP, Rodriguez-Bautista H, Garcia-Briones A, Garnica-Camacho CE, Cruz-Ruiz NG, Gonzalez-Herrera MO, Garcia-Guillen FJ, Guerrero-Gutierrez MA, Salmeron-Gonzalez JD, Romero-Gutierrez L, Canto-Castro JL, Cervantes VH; Mexico COVID-19 Critical Care Collaborative Group. Outcomes of patients with COVID-19 in the intensive care unit in Mexico: A multicenter observational study. Heart Lung. 2021 Jan-Feb;50(1):28-32. doi: 10.1016/j.hrtlng.2020.10.013. Epub 2020 Oct 21.