Characteristics and Outcomes of Patients With COVID-19 Admitted to the ICU

NCT ID: NCT04378582

Last Updated: 2020-08-26

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1589 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-05-07
• Study Completion Date: 2020-08-05

Brief Summary

This is a case series of patients with COVID-19 admitted to the largest university hospital in Sao Paulo, Brazil, during the 2020 COVID-19 pandemic. Data will be collected prospectively and retrospectively.

The main objective is to describe the characteristics of critically ill patients with COVID-19 and their clinical outcomes, and to identify risk factors associated with survival, to inform clinical decision-making and to guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.

Detailed Description

In December 2019, an outbreak of Severe Acute Respiratory Syndrome (SARS) attributed to a new coronavirus, called SARS-CoV-2, was described in the Wuhan region of China. This SARS, caused by SARS-CoV-2 was called COVID-19, spread across the globe, causing millions of cases on all continents, and thousands of deaths, being characterized as a pandemic.

COVID-19 is characterized by a flu-like syndrome, with symptoms such as fever, cough, myalgia and gastrointestinal symptoms. Most cases are mild, some even asymptomatic, but approximately 15% of patients have more severe presentation, and approximately 5% are critical (7).

The acute respiratory failure of critically ill patients with COVID-19 has different aspects, including hypoxemia of difficult treatment, associated in some cases with clotting disorders, changes in immunity and inflammatory phenomena that pose challenges for the management of these patients, whose mortality can be high.

The Hospital das Clínicas da Faculdade de Medicina de São Paulo implemented an action plan that provides for the creation of 200 ICU beds to serve patients with COVID-19. Knowing the characteristics of critically ill patients with COVID-19 and their clinical outcomes is extremely important to inform clinical decision-making and to guide the strategy to mitigate the epidemic, both within each hospital and ICU and in public health management.

Conditions

SARS-CoV 2; Respiratory Distress Syndrome, Adult; Corona Virus Infection; Critical Illness

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

COVID-19 confirmed

Patients with confirmed COVID-19 by RT-PCR or serological test

risk factors

Intervention Type: OTHER

This is an observational study, so there are no interventions. Investigators will collect data about demographics, comorbidities, and other risk factors such as severity of disease at admission, need for advanced life support, need for invasive mechanical ventilation and ventilator parameters on day1 of mechanical ventilation or ICU admission as potentially association with survival

COVID-19 suspected

Patients suspected COVID-19, as defined by clinical history and course, who have negative RT-PCR or serological test but where treated and cared for as COVID-19 patients

risk factors

Intervention Type: OTHER

This is an observational study, so there are no interventions. Investigators will collect data about demographics, comorbidities, and other risk factors such as severity of disease at admission, need for advanced life support, need for invasive mechanical ventilation and ventilator parameters on day1 of mechanical ventilation or ICU admission as potentially association with survival

Interventions

risk factors

This is an observational study, so there are no interventions. Investigators will collect data about demographics, comorbidities, and other risk factors such as severity of disease at admission, need for advanced life support, need for invasive mechanical ventilation and ventilator parameters on day1 of mechanical ventilation or ICU admission as potentially association with survival

Intervention Type: OTHER

Other Intervention Names

demographics; comorbidities; mechanical ventilation parameters; need for advanced life support

Eligibility Criteria

Inclusion Criteria

• Being admitted to one of the COVID-19 ICUs during the study period
• Suspected or confirmed COVID-19
• Expected ICU stay greater than 24 hours

Exclusion Criteria

• ICU Readmission during the same hospital stay (patients will be evaluated only during their first ICU stay)

• Minimum Eligible Age: 14 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Juliana Carvalho Ferreira

Assistant professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Juliana C Ferreira, MD

Role: PRINCIPAL_INVESTIGATOR

University of Sao Paulo - hospital das Clínicas da faculdade de medicina da USP (HCFMUSP)

Locations

Hospital das Clínicas -HCFMUSP

São Paulo, São Paulo, Brazil

Countries

Brazil

References

Taniguchi LU, Aliberti MJR, Dias MB, Jacob-Filho W, Avelino-Silva TJ. Calculating Route: Functional Trajectories and Long-Term Outcomes in Survivors of Severe COVID-19. J Nutr Health Aging. 2023;27(12):1168-1173. doi: 10.1007/s12603-023-2036-4.

Reference Type: DERIVED

PMID: 38151867 (View on PubMed)

Taniguchi LU, Avelino-Silva TJ, Dias MB, Jacob-Filho W, Aliberti MJR; COVID-19 and Frailty (CO-FRAIL) Study Group and EPIdemiology of Critical COVID-19 (EPICCoV) Study Group, for COVID Hospital das Clinicas, University of Sao Paulo Medical School (HCFMUSP) Study Group. Patient-Centered Outcomes Following COVID-19: Frailty and Disability Transitions in Critical Care Survivors. Crit Care Med. 2022 Jun 1;50(6):955-963. doi: 10.1097/CCM.0000000000005488. Epub 2022 Jan 26.

Reference Type: DERIVED

PMID: 35081061 (View on PubMed)

Ferreira JC, Ho YL, Besen BAMP, Malbuisson LMS, Taniguchi LU, Mendes PV, Costa ELV, Park M, Daltro-Oliveira R, Roepke RML, Silva JM Jr, Carmona MJC, Carvalho CRR; EPICCoV Study Group; Hirota A, Kanasiro AK, Crescenzi A, Fernandes AC, Miethke-Morais A, Bellintani AP, Canasiro AR, Carneiro BV, Zanbon BK, Batista BPSN, Nicolao BR, Besen BAMP, Biselli B, Macedo BR, Toledo CMG, Pompilio CE, Carvalho CRR, Mol CG, Stipanich C, Bueno CG, Garzillo C, Tanaka C, Forte DN, Joelsons D, Robira D, Costa ELV, Silva EM Junior, Regalio FA, Segura GC, Marcelino GB, Louro GS, Ho YL, Ferreira IA, Gois JO, Silva JM Junior, Reusing JO Junior, Ribeiro JF, Ferreira JC, Galleti KV, Silva KR, Isensee LP, Oliveira LS, Taniguchi LU, Letaif LS, Lima LT, Park LY, Chaves L Netto, Nobrega LC, Haddad L, Hajjar L, Malbouisson LM, Pandolfi MCA, Park M, Carmona MJC, Andrade MCPH, Santos MM, Bateloche MP, Suiama MA, Oliveira MF, Sousa ML, Louvaes M, Huemer N, Mendes P, Lins PRG, Santos PG, Moreira PFP, Guazzelli RM, Reis RB, Oliveira RD, Roepke RML, Pedro RAM, Kondo R, Rached SZ, Fonseca SRS, Borges TS, Ferreira T, Cobello V Junior, Sales VVT, Ferreira WSC. Characteristics and outcomes of patients with COVID-19 admitted to the ICU in a university hospital in Sao Paulo, Brazil - study protocol. Clinics (Sao Paulo). 2020;75:e2294. doi: 10.6061/clinics/2020/e2294. Epub 2020 Aug 26.

Reference Type: DERIVED

PMID: 32876113 (View on PubMed)

Other Identifiers

31382620.0.0000.0068

Identifier Type: -

Identifier Source: org_study_id