Epidemiological Analysis of the Mortality of Critically Ill Patients With the COVID-19 Admitted to the Intensive Care Unit: An Observational, Prospective and Multicenter Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 868
- 试验地点
- 1
- 主要终点
- ICU mortality
研究概览
简要总结
The recent pandemic of the COVID-19 disease has caused a national health emergency due to its severity and the clinical and social consequences of the disease. Crude mortality in Spain is 9.2%. However, the causes of death of critically ill patients with COVID-19 are unknown. To date, no treatment has been shown to be effective for the 2019-SARS-CoV-2 infection is recommended. Supportive care and isolation are recommended for infected individuals. Currently, observational studies on critically ill patients with COVID-19 have small samples. The objective is to evaluate the incidence of mortality and morbidity in COVID-19 disease in this group of critically ill patients, as well as the risk factors associated with mortality and the effectiveness of the treatments used compassionately.
详细描述
Introduction The World Health Organization (WHO) has recently declared SARS-CoV-2 (COVID-19) disease as an international alarm public health emergency. This ongoing pandemic of COVID-19 disease is devastating, despite widespread implementation of control measures, which is creating a challenge for national healthcare. Since the beginning of the epidemic until the date of this project, more than 800,000 cases have been detected in the world, of which almost 214,000 have been detected in Spain.
The results of the recent analysis of clinical characteristics in a selected cohort of 1,099 COVID-19 patients throughout China have shown that up to 15% (173 / 1,099) developed severe disease according to the American Thoracic clinical criteria for severe community pneumonia. Society, and of these seriously ill patients, 20.6% presented as admission to Intensive Care Units (ICU) (33/173, 19%), or the use of mechanical ventilation, both invasive and non-invasive. invasive (81/173, 46%) or death (14/173, 8%).
In a retrospective study that included 52 critically ill patients with COVID-19 admitted to the Intensive Care Unit (ICU) from the Wuhan Jin Yin-tan Hospital (Wuhan, China), a 28-day mortality rate of 61% was found, although the causes of death of the patients included were not reported.
Nowaday, the crude mortality in Europe is 5.4% of reported cases, although it is important to be noted that this calculation is subject to multiple notification biases and due to the different diagnostic test policies in the countries, and probable differences in healthcare and demographic models between countries. Similarly, in Spain, mortality with 213,024 cases notified to the National Surveillance Network is 10.4%. Using modeling, a mortality has been estimated among hospitalized cases that could reach 14% (95% confidence interval [CI] 3.9% -32%). However, the mortality and causes of death of critically ill patients with COVID-19 in Spain are still unknown.
To date, no specific antiviral treatment that has been shown to be effective for the 2019-SARS-CoV-2 infection is recommended. Symptomatic and supportive care, along with respiratory and contact isolation, are recommended for infected individuals.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients over 18 years of age who are admitted to the ICU with the confirmed diagnosis of COVID-19.
排除标准
- 未提供
结局指标
主要结局
ICU mortality
时间窗: events during the ICU stay, up to 3 months
rate (%)
次要结局
- ventilator-associated pneumonia(through duration of invasive ventilatory support period (from intubation date until date of successful extubation) through study completion up to 3 months)
- length of hospital stay(through study completion during ICU stay considered from ICU admission until ICU discharge as date of inclusion until the date of first documented hospital discharge or date of death from any cause, whichever came first, assessed up to 5 months)
- length of ICU stay(through study completion during ICU stay considered from ICU admission until ICU discharge as date of inclusion until the date of first documented discharge or date of death from any cause, whichever came first, assessed up to 3 months)
- duration of mechanical ventilation(period of invasive controlled ventilatory support from date of orotraqueal intubation until date of successful extubation or assessed up to 3 months whichever came first)
- hospital mortality(events through study completion during the hospital stay, up to 5 months)
- 28-day mortality(events through study completion considered from ICU admission up to 28 days)
- barotrauma(through study completion, up to 28-days)
- effectiveness of treatment(through study completion considered from ICU admission until ICU discharge, up to 3 months)
- bacteriemia(through study completion, up to 28-days)