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Clinical Trials/NCT04336345
NCT04336345
Completed
N/A

Outcomes of Patients With COVID-19 in the Intensive Care Unit: A National Observational Study (Mexico COVID-19 ICU Study)

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran2 sites in 1 country150 target enrollmentApril 1, 2020

Overview

Phase
N/A
Intervention
Not specified
Conditions
Coronavirus Infections
Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Enrollment
150
Locations
2
Primary Endpoint
Hospital mortality
Status
Completed
Last Updated
5 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 1, 2020
End Date
June 4, 2020
Last Updated
5 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Responsible Party
Principal Investigator
Principal Investigator

Silvio A. Ñamendys-Silva

Principal Investigator

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

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.

Outcomes

Primary Outcomes

Hospital mortality

Time Frame: 30 days

Mortality 30 days following hospital admission

Secondary Outcomes

  • Length of stay in the intensive care unit(Through study completion, an average of 30 days)

Study Sites (2)

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