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.

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-65
SponsorCentre Hospitalier de Lens

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial 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.

Trial design

Design model

Other

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

No trial groups listed

Trial outcomes

Primary outcomes

1

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

Time frame
28 days after inclusion

Secondary outcomes

1

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

Time frame
90 days after inclusion
2

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

Time frame
90 days after inclusion
3

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.

Time frame
90 days after inclusion
4

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.

Time frame
90 days after inclusion

Other outcomes

Sponsors and contacts

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Centre Hospitalier de Lens

Lead sponsor

University Hospital, Lille

Collaborator