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临床衰弱量表 (CFS) 作为因感染性休克入住重症监护的 ≤65 岁成年患者死亡危险因素的评估。 (Woodstock)

2026年9月24日 更新者：Centre Hospitalier de Lens

The aim of the study is to demonstrate that "frail" patients, defined as having a CFS score greater than or equal to 5, and "severely" frail patients, defined as having a CFS score between [6-7] as defined by Bagshaw et al (14), constitute an independent risk factor (RF) for mortality.

In the same way, as an exploratory study, we will try to find out whether clinical frailty constitutes a risk factor for extending the length of hospital stay, the risk of short/medium-term readmission, as has already been demonstrated for patients admitted to intensive care from all causes (15), or for impaired quality of life.

The objective is to have a better understanding of the implications and outcomes associated with pre-hospital frailty in young critically ill patients.

This analysis will also help to clarify prognoses and contribute to better decision-making on the intensity and proportionality of care, as well as providing better information and helping to manage the expectations of patients and their families in terms of survival prognosis and subsequent quality of life.

研究概览

地位

招聘中

条件

详细说明

Recent studies show the impact of frailty in a middle-aged or even young population of patients admitted to critical care in terms of mortality (13), and the persistent risk of impairment of physical and mental capacities after resuscitation (14). To date, few studies have looked at clinical frailty as a risk factor for mortality in a middle-aged or young population, more specifically those suffering from septic shock, which is already known to be a major factor in morbidity and mortality (15,16), with repercussions on long-term quality of life.

The aim of the study is to demonstrate that "frail" patients, defined as having a CFS score greater than or equal to 5, and "severely" frail patients, defined as having a CFS score between [6-7] as defined by Bagshaw et al (14), constitute an independent risk factor (RF) for mortality.

In the same way, as an exploratory study, we will try to find out whether clinical frailty constitutes a risk factor for extending the length of hospital stay, the risk of short/medium-term readmission, as has already been demonstrated for patients admitted to intensive care from all causes (15), or for impaired quality of life.

The objective is to have a better understanding of the implications and outcomes associated with pre-hospital frailty in young critically ill patients.

This analysis will also help to clarify prognoses and contribute to better decision-making on the intensity and proportionality of care, as well as providing better information and helping to manage the expectations of patients and their families in terms of survival prognosis and subsequent quality of life.

研究类型

观察性的

注册 (估计的)

200

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。

学习联系方式

研究联系人备份

学习地点

  • 法国
      • Boulogne-sur-Mer、法国、62321
        • 招聘中
        • CH Boulogne sur Mer
        • 首席研究员：
          • Charles DETOLLENAERE, Dr
      • Béthune、法国、62408
        • 招聘中
        • Ch Germon Et Gauthier
        • 首席研究员：
          • Ghada SBOUI, Dr
      • Dijon、法国、21079
        • 招聘中
        • CHU de Dijon
        • 首席研究员：
          • Jean-Pierre QUENOT, Pr
      • Lens、法国
        • 招聘中
        • CH de Lens
        • 首席研究员：
          • Guillaume DEGOUY, Doctor
      • Lille、法国、59037
        • 招聘中
        • CHU Lille
        • 首席研究员：
          • Alexandre GAUDET, Dr

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

18年 至 65年 (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

All patients admitted to intensive care will be studied for this study. Patients meeting the inclusion criteria and with no non-inclusion criteria will be included in the study after obtaining the patient's or relative's, if applicable, non-objection.

描述

Inclusion Criteria:

  • Patients aged ≥18 years and ≤ 65 years
  • Patient admitted to intensive care - resuscitation
  • Patient admitted for suspected or documented type 3 sepsis
  • Presence of vasopressor amines to maintain MAP > 65mmHg despite filling
  • Lactatemia ≥ 2 mmol/L on admission.

Exclusion Criteria:

  • Patient moribund on admission
  • Patients with severe pre-existing dementia and/or cognitive decline, suffering from severe neurodegenerative diseases that prevent the patient from living independently at baseline, including mental illness requiring institutionalisation, including acquired or congenital mental retardation, etc.
  • Pregnant women or women in labour
  • Patients under guardianship or curatorship
  • Patients deprived of their liberty
  • Patient and/or family unable to speak or understand French.

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

  • 观测模型：OTHER
  • 时间观点：PROSPECTIVE

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
To show that the frailty score on admission is a risk factor for mortality at D28, independent of known risk factors, in young patients admitted to intensive care (ICU) for sepsis or septic shock.
大体时间：28 days after inclusion

The odds ratio of frail patients to non-frail patients for the risk of all-cause death at D28
28 days after inclusion

次要结果测量

结果测量
措施说明
大体时间
To study the association, independently of known risk factors, between the frailty score on admission and mortality at day 90.
大体时间：90 days after inclusion

Time from admission to death or last news, censored at D90
90 days after inclusion
To study the association, independently of known risk factors, between the frailty score on admission and length of hospital stay
大体时间：90 days after inclusion

The time between admission to IS and live discharge from hospital, death is considered a concurrent risk, the data are censored at 90 days
90 days after inclusion
To study the association, independently of known risk factors, between the frailty score on admission and the number of days with recourse to invasive therapies
大体时间：90 days after inclusion

Number of days with mechanical ventilation, with amines, with recourse to extra-renal purification (EER) during the IS stay.
90 days after inclusion
To study the association, independently of known risk factors, between the frailty score on admission and readmission to critical care or hospitalisation before D90, among patients discharged alive from ICU before D90.
大体时间：90 days after inclusion

Readmission to critical care or hospitalisation before D90, among patients discharged alive from ICU before D90.
90 days after inclusion
To study the association, independently of known risk factors, between the frailty score on admission and describe changes in frailty between ICU admission and D90 in patients alive at D90.
大体时间：90 days after inclusion

Change in frailty score defined by the CFS (continuous) between admission and D90 (in hospital or at home).
90 days after inclusion
To study the association, independently of known risk factors, between the frailty score on admission and describe quality of life at D90 in patients alive at D90.
大体时间：90 days after inclusion

Quality of life measured by the EQ5D score at D90 (in hospital or at home).
90 days after inclusion

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

Centre Hospitalier de Lens

合作者

University Hospital, Lille

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)

2023年8月21日

初级完成 (估计的)

2027年9月18日

研究完成 (估计的)

2027年11月1日

研究注册日期

首次提交

2023年6月26日

首先提交符合 QC 标准的

2023年6月26日

首次发布 (实际的)

2023年7月3日

研究记录更新

最后更新发布 (实际的)

2026年9月28日

上次提交的符合 QC 标准的更新

2026年9月24日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 2023-02

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

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