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Outcomes of Patients With COVID-19 in the Intensive Care Unit

NCT ID: NCT04336345

Last Updated: 2020-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-04-01

Study Completion Date

2020-06-04

Brief Summary

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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

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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.

Conditions

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Coronavirus Infections COVID-19 Viral Pneumonia Human Coronavirus

Keywords

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Intensive care unit Critical care Outcomes Epidemiology

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

OTHER

Sponsor Role lead

Responsible Party

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Silvio A. Ñamendys-Silva

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Silvio A. Ñamendys-Silva, MD, MSc

Role: PRINCIPAL_INVESTIGATOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Guillermo Dominguez-Cherit, MD

Role: STUDY_DIRECTOR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Eduardo Rivero-Sigarroa, MD

Role: STUDY_CHAIR

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Locations

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Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán

Mexico City, , Mexico

Site Status

All centres from Mexico willing to contribute are Welcome.

México, , Mexico

Site Status

Countries

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Mexico

References

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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.

Reference Type RESULT
PMID: 33138974 (View on PubMed)

Other Identifiers

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3336

Identifier Type: -

Identifier Source: org_study_id