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
研究概览
地位
条件
详细说明
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.
研究类型
注册 (实际的)
联系人和位置
学习地点
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Región Metropolitana
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Santiago、Región Metropolitana、智利
- Hospital Clínico de la Universidad de Chile
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
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
学习计划
研究是如何设计的?
设计细节
- 观测模型:队列
- 时间观点:预期
研究衡量的是什么?
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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In hospital Mortality
大体时间: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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Admission to an intensive care unit (ICU)
大体时间: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)
大体时间: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)
大体时间: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)
大体时间: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).
大体时间: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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合作者和调查者
调查人员
- 首席研究员:Francisco J Gonzalez, MD、University of Chile
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
与本研究相关的术语
关键字
其他研究编号
- OAIC N° 1119/20
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)?
IPD 计划说明
药物和器械信息、研究文件
研究美国 FDA 监管的药品
研究美国 FDA 监管的设备产品
在美国制造并从美国出口的产品
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