- ICH GCP
- Реестр клинических исследований США
- Клиническое испытание 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
Обзор исследования
Статус
Условия
Подробное описание
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.
Тип исследования
Регистрация (Действительный)
Контакты и местонахождение
Места учебы
-
-
Región Metropolitana
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Santiago, Región Metropolitana, Чили
- Hospital Clínico de la Universidad de Chile
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-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
Принимает здоровых добровольцев
Полы, имеющие право на обучение
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
- Наблюдательные модели: Когорта
- Временные перспективы: Перспективный
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
In hospital Mortality
Временное ограничение: March 13th to July 10th 2020
|
Death while hospitalized
|
March 13th to July 10th 2020
|
Вторичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Admission to an intensive care unit (ICU)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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)
Временное ограничение: 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).
Временное ограничение: March 13th to July 10th 2020
|
Days from admission and length of RRT
|
March 13th to July 10th 2020
|
Соавторы и исследователи
Спонсор
Следователи
- Главный следователь: Francisco J Gonzalez, MD, University of Chile
Даты записи исследования
Изучение основных дат
Начало исследования (Действительный)
Первичное завершение (Действительный)
Завершение исследования (Действительный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
- COVID-19
- ВФНК
- Коронавирус инфекция
- SARS-CoV-2
- Clinical Scenarios
- Hospitalism
- Hospitalist
- Teaching Hospital
- Позиционирование лежа в бодрствовании
- Ventilated Prone Positioning
- Назальная канюля с высоким потоком
- Инвазивная механическая вентиляция
- Modified Charlson Comorbidity Index
- Индекс сопутствующих заболеваний Чарлсона
- Внутрибольничная смертность
Дополнительные соответствующие термины MeSH
Другие идентификационные номера исследования
- OAIC N° 1119/20
Планирование данных отдельных участников (IPD)
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Описание плана IPD
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
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