Post Intensive Care SyndromeFICUFNCT05984069
Impact of Frailty and ICU-AW on Post-ICU Fatigue Self-reported
An observational study of Post Intensive Care Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 2 sites in France.
Trial summary
After a prolonged stay in Intensive Care Unit (ICU), fatigue is the most common symptom reported by patients in the Post Intensive Care Syndrome (PICS). Other complications have been described, including ICU-acquired weakness, leading to increased morbidity and mortality after discharge. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Post Intensive Care Syndrome
- What is being tested?
- observational prospective data collection
- How many people
- 150 participants
- Where
- 2 sitesFrance
- Study dates
- 1 Jul 2022to Dec 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients admitted to intensive care, all etiologies combined, excluding immediate post-operative scheduled surgery, with mechanical ventilation for more than 5 days or length of stay in ICU over 10 days.
Who may be able to join
- Patients with a length of stay in intensive care > or equal to 7 days, or mechanical ventilation > or equal to 5 days
Who cannot join
- Scheduled surgery with admission in ICU
- Pregnancy
- Guardianship
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
France2 sites, 2 recruiting
- Recruiting
Chu Saint-Etienne
Saint-Etienne, 42000
Jérôme MOREL, MD PhD, (0)4 77 82 85 53 ext. +33, jerome.morel@chu-st-etienne.fr
Jérôme MOREL, MD PhD
- Recruiting
Hôpital Privé de la Loire
Saint-Etienne
Laurent GERGELE, MD
Benoît CREMILLIEUX, MD
About this study
After a prolonged stay in Intensive Care Unit (ICU), fatigue is the most common symptom reported by patients in the Post Intensive Care Syndrome (PICS). Other complications have been described, including ICU-acquired weakness, leading to increased morbidity and mortality after discharge. Actually, risk factors associated with post-ICU fatigue self-reported are not really known.
Read the detailed description
Frailty, defined as a decrease in physiological reserves leading to an alteration in the mechanisms of adaptation to stress, increases the incidence of PICS and could therefore be a cause of post-ICU fatigue self-reported.
The aim of this study is to identify a relationship between markers of frailty, ICU-AW, ICU story and the post-ICU fatigue self-reported 6 months discharge in patients with prolonged ICU stays.
- Conditions
- Post Intensive Care Syndrome
- Being tested
- observational prospective data collection
- Keywords
- Intensive Care Unit, frailty, fatigue, ICU acquired-weakness, FACIT-F, physical activity
- Medical subject headings
- postintensive care syndrome, Frailty, Fatigue, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
observational prospective data collectionOther
Collection of data from medical records.
| Study group | Role | What they receive |
|---|---|---|
| Patients on etiologies | Patients over 18 admitted in ICU for all etiologies with mechanical ventilation over 5 days or length of stay in ICU over 10 days will be included Receives: Other: observational prospective data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frailty
Relationship between frailty markers (CFS, IADL, sarcopenia and myosteatosis), ICU-AW, ICU story and post-ICU fatigue self-reported
Measured: 1 year
Secondary outcomes (4)
Fatigue
Prevalence of post-ICU fatigue self-reported 6 months discharge in prospective cohort
Measured: 1 year
ICU-acquired weakness and fatigue
Correlation between post-ICU fatigue self-reported and muscular strength assessed by handgrip test
Measured: 1 year
Fatigue, quality of life, anxiety and depressive disorder
Correlation between fatigue, quality of life, anxiety and depressive disorder
Measured: 1 year
Kinetic of muscle mass loss and post-ICU fatigue self-reported
Correlation between the kinetic of muscle mass loss and post-ICU fatigue self-reported
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2023
- Study start1 Jul 2022
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Intensive Care SyndromeStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de Saint EtienneThe sponsor's other registered studies.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jérôme MOREL, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Saint Etienne
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05984069
- Sponsor's protocol ID
- IRBN962022/CHUSTE
- Acronym
- FICUF
- Status last verified
- Mar 2025
- First submitted
- 2 Aug 2023
- Last updated
- 18 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Frailty and ICU-AW on Post-ICU Fatigue Self-reported
- ClinicalTrials.gov ID
- NCT05984069
- Acronym / sponsor ID
- FICUF / IRBN962022/CHUSTE
- Conditions
- Post Intensive Care Syndrome
- Keywords
- Intensive Care Unit, frailty, fatigue, ICU acquired-weakness, FACIT-F, physical activity
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire de Saint EtienneUniversity, hospital or other
- Study start
- 1 Jul 2022 (actual)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 9 Aug 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.
After a prolonged stay in Intensive Care Unit (ICU), fatigue is the most common symptom reported by patients in the Post Intensive Care Syndrome (PICS). Other complications have been described, including ICU-acquired weakness, leading to increased morbidity and mortality after discharge. Actually, risk factors associated with post-ICU fatigue self-reported are not really known.
Detailed description
Frailty, defined as a decrease in physiological reserves leading to an alteration in the mechanisms of adaptation to stress, increases the incidence of PICS and could therefore be a cause of post-ICU fatigue self-reported.
The aim of this study is to identify a relationship between markers of frailty, ICU-AW, ICU story and the post-ICU fatigue self-reported 6 months discharge in patients with prolonged ICU stays.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients on etiologies | – | Other: observational prospective data collectionPatients over 18 admitted in ICU for all etiologies with mechanical ventilation over 5 days or length of stay in ICU over 10 days will be included |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients admitted to intensive care, all etiologies combined, excluding immediate post-operative scheduled surgery, with mechanical ventilation for more than 5 days or length of stay in ICU over 10 days.
Key inclusion criteria (1 listed)
- Patients with a length of stay in intensive care > or equal to 7 days, or mechanical ventilation > or equal to 5 days
Key exclusion criteria (3 listed)
- Scheduled surgery with admission in ICU
- Pregnancy
- Guardianship
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| observational prospective data collectionCollection of data from medical records. | Other | Patients on etiologies |
Primary outcome
Frailty
Time frame: 1 year
Relationship between frailty markers (CFS, IADL, sarcopenia and myosteatosis), ICU-AW, ICU story and post-ICU fatigue self-reported
4 secondary outcomes
Fatigue
Time frame: 1 year
ICU-acquired weakness and fatigue
Time frame: 1 year
Fatigue, quality of life, anxiety and depressive disorder
Time frame: 1 year
Kinetic of muscle mass loss and post-ICU fatigue self-reported
Time frame: 1 year
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 18 Mar 2025.
- Individual participant dataSharing planned: No
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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.
Jérôme MOREL, MD PhD principal investigator
Centre Hospitalier Universitaire de Saint Etienne
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Post Intensive Care Syndrome, run by Centre Hospitalier Universitaire de Saint Etienne at 2 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 1 inclusion and 3 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 18 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 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 Jérôme MOREL, MD PhD ((0)477828553 ext. +33, jerome.morel@chu-st-etienne.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Frailty (time frame: 1 year). 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 18 Mar 2025.