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

NCT04378582 | Completed

• 1 other identifier: 31382620.0.0000.0068
• Study Type: observational
• Target: 1,589
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Critical Care

Outcome Measures

Primary Outcomes (1)

• ICU survival at 28 days

  the proportion of patients who survive to ICU discharge or for 28 days in the ICU

  28 days

Secondary Outcomes (4)

• Hospital survival at 60 days

  60 days

• Duration of mechanical ventilation

  28 days

• Need for renal replacement therapy

  28 days

• Complications during the ICU stay

  28 days

Study Arms (2)

COVID-19 confirmed

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

Other: risk factors

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

Other: risk factors

Interventions

risk factors 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

Also known as: demographics, comorbidities, mechanical ventilation parameters, need for advanced life support

COVID-19 confirmed; COVID-19 suspected

Eligibility Criteria

• Age: 14 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with confirmed COVID-19 by RT-PCR or sorological test, or suspected COVID-19, as defined by clinical history and course, who have negative RT-PCR or sorological test but where treated and cared for as COVID-19 patients, who are admitted to the ICU during the study period. Data will be collected prospectively for patients admitted to the ICU after the the date of study approval and retrospectively for patients admitted to the ICU during the COVID-19 epidemic in sao paulo, but before the study was initiated. A sample size of 300 patients was inittialy anticipated. As the epidemic in Sao Paulo grew fast, the hospital opened new ICU beds and the investigators reviewed the anticipated sample size to 500 patients. Given that the study has no risks for participants, and that informed consent was waived by the IRB, investigators intend to collect data about all patients with COVID-19 admitted to the ICUs during the study period, possibly more than the anticipated sample size.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University of Sao Paulo General Hospital: lead

Study Sites (1)

Hospital das Clínicas -HCFMUSP

São Paulo, São Paulo, 05403010, Brazil

Location

Related Publications (3)

• 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.

  PMID: 38151867 DERIVED

• 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.

  PMID: 35081061 DERIVED

• 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.

  PMID: 32876113 DERIVED

MeSH Terms

Conditions

Respiratory Distress Syndrome; Coronavirus Infections; Critical Illness

Interventions

Risk Factors; Demography; Comorbidity; Health Services Needs and Demand

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases; Respiration Disorders; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Risk; Probability; Statistics as Topic; Epidemiologic Methods; Investigative Techniques; Causality; Epidemiologic Factors; Quality of Health Care; Health Care Quality, Access, and Evaluation; Health Care Evaluation Mechanisms; Public Health; Environment and Public Health; Population Characteristics; Epidemiologic Measurements; Health Services Research; Health Planning; Health Care Economics and Organizations; Delivery of Health Care

Study Officials

• Juliana C Ferreira, MD

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor

Study Record Dates

• First Submitted: May 5, 2020
• First Posted: May 7, 2020
• Study Start: May 7, 2020
• Primary Completion: July 28, 2020
• Study Completion: August 5, 2020
• Last Updated: August 26, 2020

Record last verified: 2020-08

Locations

BR (1)