- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo 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
Descripción general del estudio
Estado
Condiciones
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
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Región Metropolitana
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Santiago, Región Metropolitana, Chile
- Hospital Clinico de la Universidad de Chile
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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
¿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
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Death while hospitalized
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March 13th to July 10th 2020
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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
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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)
Periodo de tiempo: 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)
Periodo de tiempo: 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)
Periodo de tiempo: 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).
Periodo de tiempo: 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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
- COVID-19
- HFNC
- Infección de coronavirus
- SARS-CoV-2
- Clinical Scenarios
- Hospitalism
- Hospitalist
- Teaching Hospital
- Awake Prone Positioning
- Ventilated Prone Positioning
- Cánula nasal de alto flujo
- Ventilación Mecánica Invasiva
- Modified Charlson Comorbidity Index
- Índice de comorbilidad de Charlson
- Mortalidad intrahospitalaria
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- OAIC N° 1119/20
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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