FrailtyWoodstockNCT05928767
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.
An observational study of Frailty and Septic Shock, run by Centre Hospitalier de Lens at 5 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Frailty, Septic Shock
- How many people
- 200 participants
- Where
- 5 sitesFrance
- Study dates
- 21 Aug 2023to Nov 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study 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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
5 sites in 1 country
France5 sites, 5 recruiting
- Recruiting
Ch Germon Et Gauthier
Béthune, 62408
Ghada SBOUI, Dr
- Recruiting
CH Boulogne sur Mer
Boulogne-sur-Mer, 62321
Charles DETOLLENAERE, Dr
- Recruiting
CHU de Dijon
Dijon, 21079
Jean-Pierre QUENOT, Pr
- Recruiting
CH de Lens
Lens
Guillaume DEGOUY, Doctor
- Recruiting
CHU Lille
Lille, 59037
Alexandre GAUDET, Dr
About this study
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.
Read more
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.
Read the 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.
- Conditions
- Frailty, Septic Shock
- Medical subject headings
- Frailty, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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.
Time from admission to death or last news, censored at D90
Measured: 90 days after inclusion
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
Measured: 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
Number of days with mechanical ventilation, with amines, with recourse to extra-renal purification (EER) during the IS stay.
Measured: 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.
Readmission to critical care or hospitalisation before D90, among patients discharged alive from ICU before D90.
Measured: 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.
Change in frailty score defined by the CFS (continuous) between admission and D90 (in hospital or at home).
Measured: 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.
Quality of life measured by the EQ5D score at D90 (in hospital or at home).
Measured: 90 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2023
- Study start21 Aug 2023
- Primary completion18 Sep 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FrailtyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Lens
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Lille
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05928767
- Sponsor's protocol ID
- 2023-02
- Acronym
- Woodstock
- Status last verified
- May 2026
- First submitted
- 26 Jun 2023
- Last updated
- 28 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT05928767
- Acronym / sponsor ID
- Woodstock / 2023-02
- Conditions
- Frailty, Septic Shock
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Centre Hospitalier de LensUniversity, hospital or other
- Collaborators
- University Hospital, Lille
- Study start
- 21 Aug 2023 (actual)
- Primary completion
- 18 Sep 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 3 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
The odds ratio of frail patients to non-frail patients for the risk of all-cause death at D28
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Frailty and Septic Shock, run by Centre Hospitalier de Lens at 5 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Guillaume DEGOUY, Dr (03.21.69.12.34, gdegouy@ch-lens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2026.