COVID-19 Clinical Trial
Official title:
Epidemiological Analysis of the Mortality of Critically Ill Patients With the COVID-19 Admitted to the Intensive Care Unit: An Observational, Prospective and Multicenter Study
Verified date | February 2021 |
Source | Hospital Universitario Getafe |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational [Patient Registry] |
The recent pandemic of the COVID-19 disease has caused a national health emergency due to its severity and the clinical and social consequences of the disease. Crude mortality in Spain is 9.2%. However, the causes of death of critically ill patients with COVID-19 are unknown. To date, no treatment has been shown to be effective for the 2019-SARS-CoV-2 infection is recommended. Supportive care and isolation are recommended for infected individuals. Currently, observational studies on critically ill patients with COVID-19 have small samples. The objective is to evaluate the incidence of mortality and morbidity in COVID-19 disease in this group of critically ill patients, as well as the risk factors associated with mortality and the effectiveness of the treatments used compassionately.
Status | Completed |
Enrollment | 868 |
Est. completion date | February 8, 2021 |
Est. primary completion date | February 8, 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility | Inclusion Criteria: - patients over 18 years of age who are admitted to the ICU with the confirmed diagnosis of COVID-19. Exclusion Criteria: - none |
Country | Name | City | State |
---|---|---|---|
Spain | Hospital Universitario de Getafe | Getafe | Madrid |
Lead Sponsor | Collaborator |
---|---|
Hospital Universitario Getafe | Centro Médico ABC Observatorio, Mexico, Fundación de Investigación Biomédica - Hospital Universitario de La Princesa, Hospital Ángeles Tampico, Mexico, Hospital Ángeles Tijuana, Mexico, Hospital Christus Muguerza Alta Especialidad, Nuevo León, Mexico, Hospital Christus Muguerza Betania, Puebla, Mexico, Hospital Civil de Guadalajara, Mexico, Hospital de Henares, Hospital de la Beneficiencia Espaañola, Tampico, Mexico, Hospital Gea Gonzalez Mexico, Hospital General de Mexico, Hospital General de Zona 1A Venados, Mexico, Hospital General Universitario Gregorio Marañon, Hospital H+ Querétaro, Mexico, Hospital Juarez de Mexico, Hospital Regional 1º de Octubre ISSSTE Mexico, Hospital Regional de alta Especialidad Ixta, Mexico, Hospital Universitario 12 de Octubre, Hospital Universitario de Móstoles, Hospital Universitario de Torrejón, Hospital Universitario del Tajo, Hospital Universitario Infanta Cristina, Hospital Universitario La Paz, Hospital Universitario Madrid Sanchinarro, Hospital Universitario Ramon y Cajal, Hospital Universitario Santa Creu i Sant Pau, Hospital Universitario Severo Ochoa, Hospital Universitario UANL, Mexico, Puerta de Hierro University Hospital |
Spain,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | ICU mortality | rate (%) | events during the ICU stay, up to 3 months | |
Secondary | hospital mortality | rate (%) | events through study completion during the hospital stay, up to 5 months | |
Secondary | 28-day mortality | rate (%) | events through study completion considered from ICU admission up to 28 days | |
Secondary | effectiveness of treatment | rate (%). Incidence of outcome measures (ICU mortality), and appearance of complications (pneumonia or bacteriemia during ICU stay). | through study completion considered from ICU admission until ICU discharge, up to 3 months | |
Secondary | length of ICU stay | days | through study completion during ICU stay considered from ICU admission until ICU discharge as date of inclusion until the date of first documented discharge or date of death from any cause, whichever came first, assessed up to 3 months | |
Secondary | length of hospital stay | days | through study completion during ICU stay considered from ICU admission until ICU discharge as date of inclusion until the date of first documented hospital discharge or date of death from any cause, whichever came first, assessed up to 5 months | |
Secondary | ventilator-associated pneumonia | rate (%) | through duration of invasive ventilatory support period (from intubation date until date of successful extubation) through study completion up to 3 months | |
Secondary | bacteriemia | rate (%) | through study completion, up to 28-days | |
Secondary | barotrauma | rate (%) | through study completion, up to 28-days | |
Secondary | duration of mechanical ventilation | days | period of invasive controlled ventilatory support from date of orotraqueal intubation until date of successful extubation or assessed up to 3 months whichever came first |
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