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Senior-COVID-Rea Multicentric Survey (SeniorCOVIDRea)

2020年7月28日更新者：Hospices Civils de Lyon

A Multicentric Survey on Patients Over 60 Admitted to Intensive Care for Severe Forms of COVID Infection: Search for Prognostic Criteria Associated With Survival

With the spread of COVID-19 epidemic since 2019 in Wuhan, China health plans have to be adapted continuously in response to the emergency. The first publications from the Chinese experience demonstrate an increase in the incidence of COVID-19 infections in patients over 60 years of age, a higher frequency of severe forms of the disease and therefore theoretical indications of orientation towards resuscitative care.

However, the first published data from Hubei province suggest a low benefit of resuscitation for patients between 70 and 80 years of age and null in patients over 80 years of age. These data question the individual benefit / risk balance of an orientation towards resuscitation for this category of patients, their quality of life and the concept of unreasonable obstinacy.

Among the covariates associated with resuscitation mortality described in the data published to date, cardiovascular comorbidities, certain biological covariates (LDH, creatinine, lymphocytes, neutrophils, TP, D-dimers, etc.), the time between the first symptoms and the entry into resuscitation have been identified.

The objective of this multicentric observational study is to determine the clinical and biological covariates predictive of mortality in the population of patients over 60 years of age admitted in intensive care unit, in particular by integrating functional and nutritional data from patients 1 month before COVID-19 infection.

研究概览

地位

未知

条件

COVID-19 Disease, Severe Form

干预/治疗

其他：Group1

研究类型

观察性的

注册 (预期的)

185

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

法国
- - Le Puy-en-Velay、法国
    - 招聘中
    - Resuscitation unit at Hospital Emile Roux
  - Lyon、法国
    - 招聘中
    - - Resuscitation unit of the Groupement Hospitalier Nord - Hospices Civils de Lyon
  - Lyon、法国
    - 招聘中
    - - Resuscitation unit of the Groupement Hospitalier Sud - Hospices Civils de Lyon
  - Lyon、法国
    - 招聘中
    - Resuscitation unit of the Groupement Hospitalier Centre - Hospices Civils de Lyon
  - Lyon、法国
    - 招聘中
    - Resuscitation unit of the Groupement Hospitalier Sud - Hospices Civils de Lyon
  - Villefranche-sur-Saône、法国
    - 招聘中
    - Service de Réanimation de l'Hôpital Nord Ouest
    - 接触：
      
      Max Haine, MD
  - Villeurbanne、法国、69603
    - 招聘中
    - Medipole Resuscitation unit
    - 接触：
      
      Vincent COLLANGE, MD

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

60年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

Patient over 60 in intensive care unit for severe COVID infection

描述

Inclusion Criteria:

Patient over 60
sent to the intensive care unit
whose COVID diagnosis has been established (RT-PCR and / or chest scanner)

Exclusion Criteria:

Refusal of the patient or his support person to participate in the study

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

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
Evaluation of the impact of age on mortality at 30 days after admission to intensive care 大体时间：30 days after resuscitation admission	First hypothesis: considering a single analysis variable (age), with expected mortality of 30% in patients under 70, and 70% in patients over 70 (with 40% of patients over 70), a total of 130 patients is necessary to show a statistically significant difference between these two groups with a power of 90% (bilateral alpha risk test of 5%). Since the multivariate analysis considers the integration of several factors, considering 15 factors, hoping for a coefficient of determination of 0.5 of the model, to achieve an optimism of less than 10%, it will be necessary to include 185 patients. After the publication of data on mortality in ICU in Lombardy region, Italy in April 2020, it was considered that a stopping of the trial at 185 patients would impair its statistical power and induce a potential risk of patients' selection bias. As a consequence the scientific committee decided that all the patients admitted to ICU until May 7th would be proposed the study.	30 days after resuscitation admission

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Hospices Civils de Lyon

调查人员

首席研究员：Claire FALANDRY, MD、Hospices Civils de Lyon

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2020年4月1日

初级完成 (预期的)

2020年8月15日

研究完成 (预期的)

2020年8月15日

研究注册日期

首次提交

2020年6月8日

首先提交符合 QC 标准的

2020年6月8日

首次发布 (实际的)

2020年6月9日

研究记录更新

最后更新发布 (实际的)

2020年7月30日

上次提交的符合 QC 标准的更新

2020年7月28日

最后验证

2020年7月1日