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- Ensaio Clínico NCT04758039
Clinical Characteristics and In-hospital Death of a Chilean COVID-19 Prospective Cohort
Clinical Characteristics and In-hospital Death During the First 100 Days of the COVID-19 Pandemic in Chile: A Prospective Cohort Study From a University Hospital
Visão geral do estudo
Status
Condições
Descrição detalhada
This is a prospective cohort study of adult inpatients at University of Chile Clinical Hospital, located in Santiago, Chile. We enrolled all patients aged over 18 years detected with COVID-19 admitted to the emergency department between March 1-June 11, 2020 through prospective identification using daily admission records. Briefly, COVID-19 diagnosis was made when patients had clinical findings of acute respiratory illness together with i) a positive result on reverse transcriptase chain reaction polymerase (RT-PCR) assay performed on a nasopharyngeal swab; and/or ii) chest computed tomography (CT) with typical findings of COVID-19 and absence of an alternative diagnosis. We intended to include all admitted patients during the first 100 days of the pandemic; therefore, no sample size calculation was performed. We excluded patients with length of stay less than 24 hours, nosocomial SARS-CoV-2 infection, and asymptomatic patients admitted for causes unrelated to SARS-CoV-2 infection regardless of their admission RT-PCR result.
All data were prospectively recorded for each included patient at admission and then daily until the end of the follow-up. Records were consulted by trained physicians, using a standardized data collection form, and then checked by a team of four physicians. Data discrepancy was agreed between the same clinicians.
Recorded data included demographic characteristics, comorbidities, disease onset time, associated symptoms, vital signs at the emergency department, laboratory test performed within 24 hours after admission, characteristics of the first chest CT, medication and supportive care provided, and length of stay at the hospital.
The use of antibiotics, antiviral therapy, corticosteroids, advanced oxygen delivery techniques, need for invasive mechanical ventilation (IMV), awake and ventilated prone position, use of vasopressor drugs, and need for renal replacement therapy (RRT) were explicitly recorded. Clinical management and use of these therapies were based on national recommendations from scientific societies and local protocols. Outcome collection and assignment are explained below.
Laboratory confirmation of SARS-CoV-2 infection was made using RT-PCR of nasopharyngeal swabs. All laboratory, microbiologic, and radiologic assessments were performed at the discretion of the treating physicians who were encouraged to follow local clinical guidelines. Film-array on the nasopharyngeal swab was performed for viral co-infection assessment, and urinary antigens. (pneumococcal and legionella) and blood cultures were performed for bacterial co-infection assessment. Chest radiographs and CT were also performed for all inpatients by experienced radiologists and classified as COVID-19-unrelated, typical or atypical pattern, and unspecified.
Tipo de estudo
Inscrição (Real)
Contactos e Locais
Locais de estudo
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Región Metropolitana
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Santiago, Región Metropolitana, Chile
- Hospital Clínico de la Universidad de Chile
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Método de amostragem
População do estudo
Descrição
Inclusion Criteria:
- Patients over 18 years
- Diagnosis of COVID-19 defined by clinical findings of acute respiratory illness (as per WHO guidelines) together with i) a positive result on reverse transcriptase chain reaction polymerase (RT-PCR) assay performed on a nasopharyngeal swab; and/or ii) chest computed tomography (CT) with typical findings of COVID-19 and absence of an alternative diagnosis
Exclusion Criteria:
- Length of hospital stay less than 24 hours
- Nosocomial SARS-CoV-2 infection
- Asymptomatic patients admitted for causes not related to coronavirus infection regardless their admission RT-PCR result
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Coorte
- Perspectivas de Tempo: Prospectivo
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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In hospital Mortality
Prazo: March 13th to July 10th 2020
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Death while hospitalized
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March 13th to July 10th 2020
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Admission to an intensive care unit (ICU)
Prazo: March 13th to July 10th 2020
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Admission to an intensive care unit (ICU)
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March 13th to July 10th 2020
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Use of invasive mechanical ventilation (IMV)
Prazo: March 13th to July 10th 2020
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Days from admission and length of IMV
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March 13th to July 10th 2020
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Presence of thromboembolic disease (deep vein thrombosis, pulmonary embolism or both)
Prazo: March 13th to July 10th 2020
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Described as a positive US exploration of the arms or legs, and a positive CT Scan
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March 13th to July 10th 2020
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Acute kidney injury (AKI)
Prazo: March 13th to July 10th 2020
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AKI, as per defined by the Kidney Disease Improving Global Outcomes (KDIGO) initiative
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March 13th to July 10th 2020
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Renal replacement therapy (RRT).
Prazo: March 13th to July 10th 2020
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Days from admission and length of RRT
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March 13th to July 10th 2020
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Investigador principal: Francisco J Gonzalez, MD, University of Chile
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
- COVID-19
- CNAF
- Contágio do coronavírus
- SARS-CoV-2
- Clinical Scenarios
- Hospitalism
- Hospitalist
- Teaching Hospital
- Posicionamento de bruços acordado
- Ventilated Prone Positioning
- Cânula Nasal de Alto Fluxo
- Ventilação Mecânica Invasiva
- Modified Charlson Comorbidity Index
- Índice de comorbidade de Charlson
- Mortalidade Hospitalar
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- OAIC N° 1119/20
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano IPD
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