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.
- Frailty
- Septic Shock
At a glance
- Phase
- Phase not stated
- Study type
- Observational
- Sponsor
- Centre Hospitalier de Lens
- Enrolment target
- 200
- Started
- 21 August 2023
- Main results due
- 18 September 2027
- Study sites
- 5
- Registry updated
- 28 September 2026
Can you take part?
- Ages 18 years to 65 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.
What this study is about
In the sponsor’s own words, from the registry.
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 sites(5)
Ch Germon Et Gauthier
Béthune, France
Recruiting
CH Boulogne sur Mer
Boulogne-sur-Mer, France
Recruiting
CHU de Dijon
Dijon, France
Recruiting
CH de Lens
Lens, France
Recruiting
CHU Lille
Lille, France
Recruiting
Showing 5 of 5 sites. 5 of the 5 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05928767. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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