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.

Last updated: June 21, 2024
Sponsor: Centre Hospitalier de Lens
Overall Status: Active - Recruiting

Phase

N/A

Condition

Low Blood Pressure (Hypotension)

Sepsis And Septicemia

Treatment

N/A

Clinical Study ID

NCT05928767
2023-02
  • Ages 18-65
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

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

Exclusion Criteria:

  • Patient moribund on admission

  • Patients with severe pre-existing dementia and/or cognitive decline, suffering fromsevere neurodegenerative diseases that prevent the patient from living independentlyat baseline, including mental illness requiring institutionalisation, includingacquired 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 Design

Total Participants: 200
Study Start date:
August 21, 2023
Estimated Completion Date:
December 01, 2025

Study 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.

Connect with a study center

  • CH Boulogne sur Mer

    Boulogne-sur-Mer, 62321
    France

    Site Not Available

  • Ch Germon Et Gauthier

    Béthune, 62408
    France

    Active - Recruiting

  • CHU de Dijon

    Dijon, 21079
    France

    Active - Recruiting

  • CHU Lille

    Lille, 59037
    France

    Active - Recruiting

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