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临床试验/NCT04758039
NCT04758039已完成不适用

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

University of Chile1 个研究点 分布在 1 个国家目标入组 395 人开始时间: 2020年3月13日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
395
试验地点
1
主要终点
In hospital Mortality

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

In hospital Mortality

时间窗: March 13th to July 10th 2020

Death while hospitalized

次要结局

  • Admission to an intensive care unit (ICU)(March 13th to July 10th 2020)
  • Presence of thromboembolic disease (deep vein thrombosis, pulmonary embolism or both)(March 13th to July 10th 2020)
  • Renal replacement therapy (RRT).(March 13th to July 10th 2020)
  • Use of invasive mechanical ventilation (IMV)(March 13th to July 10th 2020)
  • Acute kidney injury (AKI)(March 13th to July 10th 2020)

研究者

发起方
University of Chile
申办方类型
Other
责任方
Principal Investigator
主要研究者

Francisco Gonzalez

Assistant Professor

University of Chile

研究点 (1)

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