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敗血症性ショックのため集中治療室に入院した65歳以下の成人患者における死亡の危険因子としての臨床虚弱スケール(CFS)の評価。 (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.

調査の概要

状態

募集

条件

詳細な説明

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

研究の種類

観察的

入学 (推定)

200

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究連絡先

名前：MELANIE VERLAY
電話番号：03.21.69.10.28
メール：mverlay@ch-lens.fr

研究連絡先のバックアップ

名前：Guillaume DEGOUY, Dr
電話番号：03.21.69.12.34
メール：gdegouy@ch-lens.fr

研究場所

フランス
- - Boulogne-sur-Mer、フランス、62321
    - 募集
    - CH Boulogne sur Mer
    - 主任研究者：
      
      Charles DETOLLENAERE, Dr
  - Béthune、フランス、62408
    - 募集
    - Ch Germon Et Gauthier
    - 主任研究者：
      
      Ghada SBOUI, Dr
  - Dijon、フランス、21079
    - 募集
    - CHU de Dijon
    - 主任研究者：
      
      Jean-Pierre QUENOT, Pr
  - Lens、フランス
    - 募集
    - CH de Lens
    - 主任研究者：
      
      Guillaume DEGOUY, Doctor
  - Lille、フランス、59037
    - 募集
    - CHU Lille
    - 主任研究者：
      
      Alexandre GAUDET, Dr

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

18年～65年 (大人、高齢者)

健康ボランティアの受け入れ

いいえ

受講資格のある性別

全て

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

観測モデル：OTHER
時間の展望：PROSPECTIVE

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
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. 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
To study the association, independently of known risk factors, between the frailty score on admission and mortality at day 90. 時間枠：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 時間枠：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 時間枠：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. 時間枠：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. 時間枠：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. 時間枠：90 days after inclusion	Quality of life measured by the EQ5D score at D90 (in hospital or at home).	90 days after inclusion

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Centre Hospitalier de Lens

協力者

University Hospital, Lille

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2023年8月21日

一次修了 (推定)

2027年9月18日

研究の完了 (推定)

2027年11月1日

試験登録日

最初に提出

2023年6月26日

QC基準を満たした最初の提出物