Evaluation of the Clinical Frailty Scale (CFS) as a Risk Factor of Mortality in Adult Patients ≤65 Years of Age Admitted to Intensive Care for Septic Shock. (Woodstock)

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.

Study Overview

• Status: Recruiting
• Conditions: Septic Shock; Frailty

Detailed Description

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: MELANIE VERLAY; Phone Number: 03.21.69.10.28; Email: mverlay@ch-lens.fr
• Study Contact Backup: Name: Guillaume DEGOUY, Dr; Phone Number: 03.21.69.12.34; Email: gdegouy@ch-lens.fr

Study Locations

• France
  • Boulogne-sur-Mer, France, 62321
    • Recruiting
    • CH Boulogne sur Mer
    • Principal Investigator: Charles DETOLLENAERE, Dr
  • Béthune, France, 62408
    • Recruiting
    • Ch Germon Et Gauthier
    • Principal Investigator: Ghada SBOUI, Dr
  • Dijon, France, 21079
    • Recruiting
    • CHU de Dijon
    • Principal Investigator: Jean-Pierre QUENOT, Pr
  • Lens, France
    • Recruiting
    • CH de Lens
    • Principal Investigator: Guillaume DEGOUY, Doctor
  • Lille, France, 59037
    • Recruiting
    • CHU Lille
    • Principal Investigator: Alexandre GAUDET, Dr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	The odds ratio of frail patients to non-frail patients for the risk of all-cause death at D28	28 days after inclusion

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To study the association, independently of known risk factors, between the frailty score on admission and mortality at day 90.	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	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	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.	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.	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.	Quality of life measured by the EQ5D score at D90 (in hospital or at home).	90 days after inclusion

Collaborators and Investigators

• Sponsor: Centre Hospitalier de Lens
• Collaborators: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2023
• Primary Completion (Estimated): September 29, 2026
• Study Completion (Estimated): November 1, 2026

Study Registration Dates

• First Submitted: June 26, 2023
• First Submitted That Met QC Criteria: June 26, 2023
• First Posted (Actual): July 3, 2023

Study Record Updates

• Last Update Posted (Actual): May 8, 2026
• Last Update Submitted That Met QC Criteria: May 5, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Infections; Sepsis; Systemic Inflammatory Response Syndrome; Inflammation; Shock; Pathological Conditions, Signs and Symptoms; Frailty; Shock, Septic
• Other Study ID Numbers: 2023-02

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No