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临床试验/NCT04371471
NCT04371471已完成不适用

On-admission Multifactorial Evaluation of Inflammation as Prognostic Marker of Death in Patients Diagnosed With Coronavirus Infectious Disease (COVID-19) Syndrome

Groupe Hospitalier de la Rochelle Ré Aunis1 个研究点 分布在 1 个国家目标入组 91 人开始时间: 2020年3月1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
91
试验地点
1
主要终点
Number of Participants With Normal and Above Triage (STC-19) Score

研究概览

简要总结

During this pandemic period, the goal of the health care system is to optimize the use of intensive care services for patients infected with SARS-CoV-2, given the frequency of complications that can lead to high mortality.

When patients with suspected or confirmed COVID-19 are admitted to hospital, whether or not they are symptomatic, there is currently no method to predict who will progress to complications requiring the use of intensive measures in 24-48 hours.

详细描述

The body undergoes a systemic adaptation response to severe illness. Elevated cortisol and systemic inflammation are two key responses. Along with hypotension, this triad can lead to end-organ failure and death in critical illness. In critical illness, serum cortisol is dissociated from its tissular activity. We have developed a formula that calculates tissular action of cortisol called the cortisol index. It correlates in chronic ambulatory illness, and acute illness such as myocardial infarction (manuscript pending). Elevated neutrophil to lymphocyte ration (NLR) is a marker of systemic inflammation and predictor of mortality on admission to the emergency department. We have confirmed this in a retrospective and prospective study (manuscript pending, data available upon request).

The purpose of this study is to evaluate a triage score (STC-19) based on patients' biological state at the time of diagnosis, to objectively determine which patients are most likely to require intensive medical services within 24-48 hours of presentation of the emergency department.

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

入选标准

  • Patient with clinical signs of CoV-2-SARS infection
  • Complete blood count test and systolic blood pressure available at the time of diagnosis
  • Informed of the study.

排除标准

  • Women beyond the 1st trimester of pregnancy
  • Persons under-the-age-of or legally-denied medical decision-making capacity by a judicial or administrative decision,
  • Persons of full age who are subject to a legal protection measure,
  • Persons unable to consent,
  • Persons who are not members of or beneficiaries of a social welfare program administered by the Republic of France
  • Patient's refusal to participate in the study.

结局指标

主要结局

Number of Participants With Normal and Above Triage (STC-19) Score

时间窗: Day 0

Correlation between the STC-19 score based on biological measures at the time of diagnosis and patient outcome (deceased or alive within 29 days of hospitalization) The STC-19 score is based on the genito-thyroid index (GTi) calculated from the neutrophil-to-lymphocyte ratio (NLR) and the cortisol index : Normal value for cortisol range from 3 to 7 Normal value for GTi range from 1.5 to 2.5

次要结局

  • Number of Participants With Normal and Above Genito-thyroid Index (GTi) Value(Day 5)

研究者

发起方
Groupe Hospitalier de la Rochelle Ré Aunis
申办方类型
Other
责任方
Sponsor

研究点 (1)

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