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.
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Frailty, Septic Shock. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- France
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
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.
Primary outcome measures
- 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. [Time frame: 28 days after inclusion]
Secondary outcome measures (6)
- To study the association, independently of known risk factors, between the frailty score on admission and mortality at day 90. [Time frame: 90 days after inclusion]
- To study the association, independently of known risk factors, between the frailty score on admission and length of hospital stay [Time frame: 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 [Time frame: 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. [Time frame: 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. [Time frame: 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. [Time frame: 90 days after inclusion]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
France · 5 centers
- Ch Germon Et Gauthier — Béthune
- CH Boulogne sur Mer — Boulogne-sur-Mer
- CHU de Dijon — Dijon
- CH de Lens — Lens
- CHU Lille — Lille
Identifiers
NCT: NCT05928767 · 2023-02