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Clinical Characteristics and In-hospital Death of a Chilean COVID-19 Prospective Cohort

16 de febrero de 2021 actualizado por: Francisco Gonzalez, University of Chile

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

The investigators planned to examine a cohort of admitted patients at University of Chile Clinical Hospital with COVID-19 diagnosis. Authors report data on mortality, ICU admission, need of invasive mechanical ventilation, awake and ventilated prone positioning, use of High Flow Nasal Cannula, Thromboembolic disease, Acute Kidney Injury (AKI) and Renal Replacement Therapy. Additionally, the risk of in-hospital death according to chronic disease burden and severity of illness at admission was assessed.

Descripción general del estudio

Estado

Terminado

Descripción detallada

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 estudio

De observación

Inscripción (Actual)

395

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Región Metropolitana
      • Santiago, Región Metropolitana, Chile
        • Hospital Clinico de la Universidad de Chile

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Método de muestreo

Muestra no probabilística

Población de estudio

Adults with confirmed infection by SARS-CoV 2 Since the purpose of this study was to include all the patients admitted during the first 100 days of the pandemic, no sample size calculation was performed.

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Modelos observacionales: Grupo
  • Perspectivas temporales: Futuro

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
In hospital Mortality
Periodo de tiempo: March 13th to July 10th 2020
Death while hospitalized
March 13th to July 10th 2020

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Admission to an intensive care unit (ICU)
Periodo de tiempo: March 13th to July 10th 2020
Admission to an intensive care unit (ICU)
March 13th to July 10th 2020
Use of invasive mechanical ventilation (IMV)
Periodo de tiempo: March 13th to July 10th 2020
Days from admission and length of IMV
March 13th to July 10th 2020
Presence of thromboembolic disease (deep vein thrombosis, pulmonary embolism or both)
Periodo de tiempo: March 13th to July 10th 2020
Described as a positive US exploration of the arms or legs, and a positive CT Scan
March 13th to July 10th 2020
Acute kidney injury (AKI)
Periodo de tiempo: March 13th to July 10th 2020
AKI, as per defined by the Kidney Disease Improving Global Outcomes (KDIGO) initiative
March 13th to July 10th 2020
Renal replacement therapy (RRT).
Periodo de tiempo: March 13th to July 10th 2020
Days from admission and length of RRT
March 13th to July 10th 2020

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Investigadores

  • Investigador principal: Francisco J Gonzalez, MD, University of Chile

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

13 de marzo de 2020

Finalización primaria (Actual)

10 de julio de 2020

Finalización del estudio (Actual)

10 de julio de 2020

Fechas de registro del estudio

Enviado por primera vez

15 de febrero de 2021

Primero enviado que cumplió con los criterios de control de calidad

15 de febrero de 2021

Publicado por primera vez (Actual)

17 de febrero de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

18 de febrero de 2021

Última actualización enviada que cumplió con los criterios de control de calidad

16 de febrero de 2021

Última verificación

1 de febrero de 2021

Más información

Términos relacionados con este estudio

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

Indeciso

Descripción del plan IPD

Anonymized data will be shared upon request

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

producto fabricado y exportado desde los EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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