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临床试验/NCT04896944
NCT04896944已完成不适用

Is Precariousness a Risk Factor for COVID-19 Mortality in Intensive Care?

Centre Hospitalier de Saint-Denis1 个研究点 分布在 1 个国家目标入组 200 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
200
试验地点
1
主要终点
Death

研究概览

简要总结

Is precariousness a risk factor for COVID-19 mortality in intensive care units ?

Abstract

Background: During the SARS-CoV-2 pandemic, the first wave overwhelmed hospitals in Paris area (Ile-de-France) with a variable impact depending on the territory. Several studies highlighted variable ICU mortality rates during COVID-19 surges across territories (10 to 60%) with higher rates in those most affected by poverty. We assessed the impact of precariousness, as an independent risk factor, on mortality linked to Covid-19 between ICUs at Delafontaine hospital and Ambroise Paré hospital.

Method: Investigators carry out a retrospective observational cohort study of consecutive ICU patients aged ≥ 18 years admitted at Delafontaine and Ambroise Paré hospitals during the first wave of the Covid-19 outbreak in order to compare mortality rates according to predefined risk factors (age, diabetes, arterial hypertension, BMI, active solid or haematological cancer, IGS2, poverty rate at the threshold of 60% (%) according to the island grouped for statistical information (IRIS)37 of the patient, invasive ventilation or not) that include precariousness.

Results:

Conclusion:

详细描述

Introduction:

During the SARS-CoV-2 pandemic, the first health crisis overwhelmed hospitals in Ile de France with a different impact depending on the territory . According to data on deaths registered in the civil registry published by the National Institute of Statistics and Economic Studies (INSEE), Seine-Saint-Denis has recorded the highest excess mortality rate in Ile-de-France, over the period from 1st March to 19th April. Seine-Saint-Denis has an excess mortality of over 130%, compared to over 74% in Paris and over 122% in Hauts-de-Seine. By considering the mortality rates according to the place of residence rather than the place of death, excess mortality has reached 134% in Seine-Saint-Denis, over 114% in Hauts-de-Seine, and over 99 % regarding Paris.

Seine-Saint-Denis is one of the French department most affected by poverty, which is a factor of vulnerability, and constitutes a risk factor for mortality after hospitalization in the context of traumatic, cardiovascular or cancer pathologies. In addition, precarious people have a reduced life expectancy, but it is not a risk factor for ICU mortality when considering severity on admission.

In Ile-de-France, the mortality rate in intensive care could significantly vary depending on the territory (10 to 60%), reflecting thus the disparities noticed in mortality from Covid-19. The opensafely study enumerates some of the primary mortality risk factors from Covid-19 such as age, sex, obesity, smoking, ethnicity, diabetes, solid and hematological cancers, kidney failure, chronic cardiorespiratory diseases but also precariousness independently and with a dose-response effect, whereas these risk factors could result from precariousness itself.

Knowing these risk factors for severe infection with Covid-19, investigators assume a link between precariousness and mortality in intensive care with Covid-19 pneumonia.

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

入选标准

  • •all patients hospitalized in intensive care at Delafontaine hospital (12 intensive care beds and 6 CCU beds) and Ambroise Paré hospital (12 intensive care beds and 6 CCU beds) that has developed a Covid-19 pneumonitis confirmed biologically by nasopharyngeal PCR or on deep respiratory samples (bronchial, tracheal aspiration or bronchoalveolar lavage) or strongly suspected with a compatible CT27 and a very evocative clinical history depending on the practitioner in charge would be included into the study.

排除标准

  • •all minor patients under the age of 18 and patients transferred after less than 24 hours of care in the service would be excluded.

结局指标

主要结局

Death

时间窗: 90 days

次要结局

  • Death in ICU(90 days)
  • ICU length of stay(6 months)
  • Hospital length of stay(6 months)

研究者

发起方
Centre Hospitalier de Saint-Denis
申办方类型
Other
责任方
Sponsor

研究点 (1)

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