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临床试验/NCT04454372
NCT04454372已完成不适用

Clinical Characteristics and Outcomes of 187 Critically Ill Patients With COVID-19

Hospital Sao Domingos1 个研究点 分布在 1 个国家目标入组 187 人开始时间: 2020年7月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
187
试验地点
1
主要终点
Outcome 30 days after ICU admission

研究概览

简要总结

This case series describes the clinical characteristics, treatment and outcomes of patients with laboratory confirmed COVID-19 admitted to a 35 beds intensive care unit of a tertiary hospital in Northeast Brazil.

详细描述

This retrospective observational study will be carried out at Hospital São Domingos, state of Maranhao, Brasil. It is a tertiary hospital with 450 beds and six Intensive Care Units (ICU) with a total of 63 beds. With the admission of the first patients with Coronavirus Disease 2019 (COVID-19) as of March 20, we initially made available a 12 beds ICU exclusively for the treatment of patients with COVID-19. At the beginning of April, the number of beds was increased to 35 and, immediately afterwards, two semi-intensive units (16 and 21 beds) were created for patients in need of non-invasive respiratory support, with the 35 beds ICU 35 dedicated to receive only patients in need of high-level support (usually invasive mechanical ventilation) with or without other organ dysfunctions.

In the period from March 20 to June 15, 2020, 935 patients with confirmed diagnosis (RT-PCR) of COVID-19 were admitted to the hospital and 187 of them were treated in the ICU.

Data were obtained from the hospital's electronic medical record. Demographic and severity data included age, sex, Simplified Acute Physiology 3 (SAPS 3) and Sequential Organ Failure Assessment (SOFA) scores at admission, nutritional risk determined by Nutritional Risk Screening 2002 (NRS-2002) and commodities. Clinical and laboratory data on arrival at the ICU including Partial pressure of oxygen in arterial bood / Inspired fraction of oxygen (PaO2 / FIO2) complete blood count and PCR D-dimer, ferritin, fibrinogen and lactic acid dehydrogenasew (LDH). Drug interventions including use of hydroxychloroquine, corticosteroids, heparin, tocilizumab. Characteristics of invasive and non-invasive respiratory support, use of prone position, ECMO and vasoactive drugs. The main complications, acute kidney injury requiring hemodialysis, secondary infectious complications will be documented as well as the outcomes.

研究设计

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

入排标准

年龄范围
1 Year 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients admitted to the 35 beds ICU between March 20 and June 15, 2020 with laboratory confirmed diagnosis of COVID-19 (RT-PCR).

排除标准

  • Patients admitted to the ICU in which the RT-PCR was negative, and patients that did not require high level life support (RRT, Prone position, ECMO, hemodymnamic monitoring and support).

结局指标

主要结局

Outcome 30 days after ICU admission

时间窗: 30 days after admission

A seven-category ordinal scale consisting of: 1. Death; 2. hospitalized, on invasive mechanical ventilation; 3. hospitalized, on non-invasive ventilation; 4. hospitalized, requiring supplemental oxygen; 5. hospitalized not requiring supplemental oxygen; 6. hospitalized, not requiring supplemental oxygen - no longer requires ongoing medical care. 7 Not hospitalized

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

José Raimundo Araujo de Azevedo

Principal investigator

Hospital Sao Domingos

研究点 (1)

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