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
1 other identifier
observational
200
1 country
5
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Aug 2023
Typical duration for all trials
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 26, 2023
CompletedFirst Posted
Study publicly available on registry
July 3, 2023
CompletedStudy Start
First participant enrolled
August 21, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 29, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2026
May 8, 2026
May 1, 2026
3.1 years
June 26, 2023
May 5, 2026
Conditions
Outcome Measures
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
28 days after inclusion
Secondary Outcomes (6)
To study the association, independently of known risk factors, between the frailty score on admission and mortality at day 90.
90 days after inclusion
To study the association, independently of known risk factors, between the frailty score on admission and length of hospital stay
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
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.
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.
90 days after inclusion
- +1 more secondary outcomes
Eligibility Criteria
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.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Centre Hospitalier de Lenslead
- University Hospital, Lillecollaborator
Study Sites (5)
Ch Germon Et Gauthier
Béthune, 62408, France
CH Boulogne sur Mer
Boulogne-sur-Mer, 62321, France
CHU de Dijon
Dijon, 21079, France
CH de Lens
Lens, France
CHU Lille
Lille, 59037, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2023
First Posted
July 3, 2023
Study Start
August 21, 2023
Primary Completion (Estimated)
September 29, 2026
Study Completion (Estimated)
November 1, 2026
Last Updated
May 8, 2026
Record last verified: 2026-05