Post Intensive Care Syndrome (PICS)SOPICSNCT06697236
SOcioeconomics Status and Post-Intensive Care Syndrome
An observational study of Post Intensive Care Syndrome (PICS), run by Centre Hospitalier Universitaire Dijon at 1 site in France.
Trial summary
Intensive care units provide care for patients with multiple organ failure, with the aim (over and above survival) of guaranteeing an acceptable quality of life after resuscitation and proportionate care in accordance with the therapeutic plan and the wishes of the patient and his family. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Post Intensive Care Syndrome (PICS)
- What is being tested?
- EPICES score, PICS evaluation and PICS-F evaluation
- How many people
- 180 participants
- Where
- 1 siteFrance
- Study dates
- 26 Sep 2025to Sep 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Eligible patients will be identified on leaving intensive care.
Who may be able to join
- Patients :
- Patients hospitalised in intensive care for septic shock or acute respiratory distress syndrome or with a duration of mechanical ventilation and/or treatment with catecholamines ≥ 3 days (population targeted by the HAS 2023 recommendations for the risk of developing a PICS).
- Patients who have given their oral consent after having been informed about the conduct of this study.
- Patient's relatives :
- Person identified by the patient as the reference person or the person to be informed
- Person who has given oral consent after having been informed about the conduct of this study
- Person able to complete a questionnaire
- Limited to 1 relative per patient
Who cannot join
- Patients :
- Patient not affiliated to or not benefiting from a social security scheme
- Patients who are minors
- Person subject to a legal protection measure (curatorship, guardianship)
- Person subject to a legal protection measure
- Patient unable to understand the French language and to consent to the research protocol
Show all 13Show fewer
- Major incapable or unable to express consent
- A bedridden or demented patient
- Patient's relatives :
- Minor
- Relative unable to be interviewed due to state of health
- Relative under guardianship, curatorship or safeguard of justice
- Relative unable to understand the French language and to consent to the research protocol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Dijon Bourgogne
Dijon, 21000
Jean-Pierre QUENOT, 0380293685 ext. +33, jean-pierre.quenot@chu-dijon.fr
About this study
Intensive care units provide care for patients with multiple organ failure, with the aim (over and above survival) of guaranteeing an acceptable quality of life after resuscitation and proportionate care in accordance with the therapeutic plan and the wishes of the patient and his family. In addition to the independent prognostic factors for mortality that are well known in intensive care (reason for admission, initial severity, etc.) and after intensive care (age, co-morbidities, life trajectory, etc.), patients who survive are more likely to have a good quality of life. ), patients who survive are likely to present complications with variable repercussions, depending in part on their demographic characteristics (age, comorbidities, presence or absence of a chronic pathology, etc.), their frailty, social determinants of health and, logically enough, the reason for admission and the occurrence of complications during hospitalisation.
Thus, the potential consequences of a stay in intensive care may take several forms: 1) quality of life on leaving intensive care, 2) the occurrence or persistence of physical, psychological/psychiatric and/or cognitive symptoms grouped together under the term Post Intensive Care Syndrome (PICS) and PICS-F when these manifestations concern the patient's relatives (F for Family) and 3) socio-economic status (SE) prior to admission with risks of a drop in income, social isolation and withdrawal, and the development of feelings of uselessness or of being a burden on family and friends. This last point is particularly important because social inequalities in health (SIH), which are a true reflection of the link between health and social determinants (income and social status, employment and working conditions, education/literacy, healthy environment and support, behaviours, access to health services), represent a higher risk of being admitted to intensive care with greater severity and a more serious short-term prognosis in intensive care and post-resuscitation. The concept of PICS and PICS-F makes it possible to highlight the importance of each of these physical, psychological and cognitive dimensions in the main spheres of the daily life of patients and their relatives after resuscitation: family and social life, professional and private activity, economic resources. In addition to the manifestations of PICS, we must therefore add the impact that SE status can have on the pre- and post-resuscitation phases of a stay in intensive care. In this way, SE status and SIH reveal the weaknesses of a healthcare system and the social gradient associated with precariousness. As was shown during the Covid-19 pandemic, SIHs are probably factors that can add up and/or potentiate each other and have a significant influence on the outcome of patients leaving the intensive care unit and beyond.
" Post Intensive Care Syndrome " (PICS) The frequency and intensity of disabling symptoms in the ICU and in the aftermath of an ICU stay vary widely. These may be physical (e.g. extreme muscle weakness in around 40% of patients), psychological (anxiety, depression, post-traumatic stress disorder in 20 to 35% of patients) or cognitive (memory loss, loss of verbal fluency, problems with attention, executive functions and visio-spatial perception in 20 to 40% of patients). Cognitive impairment occurs most often in the aftermath of an acute confusional state ("delirium"), which develops in intensive care and whose causes are multifactorial, but linked in particular to the underlying disease and the treatments administered in intensive care. The aim, after the stay in intensive care and on return home, is to be able to detect one or other of the components of the PICS using easy-to-use tools as part of personalised monitoring by telephone, during a consultation in a GP's surgery or hospital, or during a medical visit to the patient's home, in order to adapt physical, cognitive, psychological and speech rehabilitation and the return to an acceptable quality of life for patients and their families. Patient follow-up, particularly in the context of the PICS, could be monitored by a resuscitation doctor as part of a post-resuscitation consultation, as proposed by the Haute Autorité de Santé in France in June 2023.
- Conditions
- Post Intensive Care Syndrome (PICS)
- Being tested
- EPICES score, PICS evaluation, PICS-F evaluation
- Medical subject headings
- postintensive care syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EPICES scoreOther
EPICES score used to group participants as "precarious" and "non precarious".
PICS evaluationOther
- Assessment of physical symptoms using the Timed up and go test (TUG)
- Assessment of depressive symptoms using the PHQ-8 and anxiety symptoms using the GAD-7 and screening for post-traumatic stress disorder using the IES-R
- Assessment of cognitive disorders using the MoCA
PICS-F evaluationOther
- Assessment of depressive symptoms using the PHQ-8 and anxiety symptoms using the GAD-7
- Screening for post-traumatic stress disorder using the IES-R
| Study group | Role | What they receive |
|---|---|---|
| patient | 90 intensive care patients Receives: Other: EPICES score; Other: PICS evaluation | |
| patient's relatives | a maximum of 90 of the patient's relatives Receives: Other: EPICES score; Other: PICS-F evaluation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of PICS
Measured: Up to 12 months after leaving intensive care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start26 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (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 Syndrome (PICS)Studies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire DijonThe 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire Dijon
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06697236
- Sponsor's protocol ID
- LABRUYERE AOI 2023
- Acronym
- SOPICS
- Status last verified
- Sep 2025
- First submitted
- 18 Nov 2024
- Last updated
- 2 Oct 2025
- 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 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- SOcioeconomics Status and Post-Intensive Care Syndrome
- ClinicalTrials.gov ID
- NCT06697236
- Acronym / sponsor ID
- SOPICS / LABRUYERE AOI 2023
- Conditions
- Post Intensive Care Syndrome (PICS)
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire DijonUniversity, hospital or other
- Study start
- 26 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 20 Nov 2024 (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.
Intensive care units provide care for patients with multiple organ failure, with the aim (over and above survival) of guaranteeing an acceptable quality of life after resuscitation and proportionate care in accordance with the therapeutic plan and the wishes of the patient and his family. In addition to the independent prognostic factors for mortality that are well known in intensive care (reason for admission, initial severity, etc.) and after intensive care (age, co-morbidities, life trajectory, etc.), patients who survive are more likely to have a good quality of life. ), patients who survive are likely to present complications with variable repercussions, depending in part on their demographic characteristics (age, comorbidities, presence or absence of a chronic pathology, etc.), their frailty, social determinants of health and, logically enough, the reason for admission and the occurrence of complications during hospitalisation.
Thus, the potential consequences of a stay in intensive care may take several forms: 1) quality of life on leaving intensive care, 2) the occurrence or persistence of physical, psychological/psychiatric and/or cognitive symptoms grouped together under the term Post Intensive Care Syndrome (PICS) and PICS-F when these manifestations concern the patient's relatives (F for Family) and 3) socio-economic status (SE) prior to admission with risks of a drop in income, social isolation and withdrawal, and the development of feelings of uselessness or of being a burden on family and friends. This last point is particularly important because social inequalities in health (SIH), which are a true reflection of the link between health and social determinants (income and social status, employment and working conditions, education/literacy, healthy environment and support, behaviours, access to health services), represent a higher risk of being admitted to intensive care with greater severity and a more serious short-term prognosis in intensive care and post-resuscitation. The concept of PICS and PICS-F makes it possible to highlight the importance of each of these physical, psychological and cognitive dimensions in the main spheres of the daily life of patients and their relatives after resuscitation: family and social life, professional and private activity, economic resources. In addition to the manifestations of PICS, we must therefore add the impact that SE status can have on the pre- and post-resuscitation phases of a stay in intensive care. In this way, SE status and SIH reveal the weaknesses of a healthcare system and the social gradient associated with precariousness. As was shown during the Covid-19 pandemic, SIHs are probably factors that can add up and/or potentiate each other and have a significant influence on the outcome of patients leaving the intensive care unit and beyond.
" Post Intensive Care Syndrome " (PICS) The frequency and intensity of disabling symptoms in the ICU and in the aftermath of an ICU stay vary widely. These may be physical (e.g. extreme muscle weakness in around 40% of patients), psychological (anxiety, depression, post-traumatic stress disorder in 20 to 35% of patients) or cognitive (memory loss, loss of verbal fluency, problems with attention, executive functions and visio-spatial perception in 20 to 40% of patients). Cognitive impairment occurs most often in the aftermath of an acute confusional state ("delirium"), which develops in intensive care and whose causes are multifactorial, but linked in particular to the underlying disease and the treatments administered in intensive care. The aim, after the stay in intensive care and on return home, is to be able to detect one or other of the components of the PICS using easy-to-use tools as part of personalised monitoring by telephone, during a consultation in a GP's surgery or hospital, or during a medical visit to the patient's home, in order to adapt physical, cognitive, psychological and speech rehabilitation and the return to an acceptable quality of life for patients and their families. Patient follow-up, particularly in the context of the PICS, could be monitored by a resuscitation doctor as part of a post-resuscitation consultation, as proposed by the Haute Autorité de Santé in France in June 2023.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patient | – | Other: EPICES score, Other: PICS evaluation90 intensive care patients |
| patient's relatives | – | Other: EPICES score, Other: PICS-F evaluationa maximum of 90 of the patient's relatives |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Eligible patients will be identified on leaving intensive care.
Key inclusion criteria (8 listed)
- Patients hospitalised in intensive care for septic shock or acute respiratory distress syndrome or with a duration of mechanical ventilation and/or treatment with catecholamines ≥ 3 days (population targeted by the HAS 2023 recommendations for the risk of developing a PICS).
- Patients who have given their oral consent after having been informed about the conduct of this study.
- Person identified by the patient as the reference person or the person to be informed
- Person who has given oral consent after having been informed about the conduct of this study
- Person able to complete a questionnaire
Key exclusion criteria (13 listed)
- Patient not affiliated to or not benefiting from a social security scheme
- Patients who are minors
- Person subject to a legal protection measure (curatorship, guardianship)
- Person subject to a legal protection measure
- Patient unable to understand the French language and to consent to the research protocol
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 |
|---|---|---|
| EPICES scoreEPICES score used to group participants as "precarious" and "non precarious". | Other | patient, patient's relatives |
| PICS evaluation* Assessment of physical symptoms using the Timed up and go test (TUG) * Assessment of depressive symptoms using the PHQ-8 and anxiety symptoms using the GAD-7 and screening for post-traumatic stress disorder using the IES-R * Assessment of cognitive disorders using the MoCA | Other | patient |
| PICS-F evaluation* Assessment of depressive symptoms using the PHQ-8 and anxiety symptoms using the GAD-7 * Screening for post-traumatic stress disorder using the IES-R | Other | patient's relatives |
Primary outcome
Number of PICS
Time frame: Up to 12 months after leaving intensive care
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 2 Oct 2025.
Related trials for Post Intensive Care Syndrome (PICS)
Not yet recruiting
Feasibility Study on the Use of a Walking Exoskeleton in the Intensive Care Unit
Neuromuscular Disease in Post-Intensive Care Syndrome
Not yet recruitingObservational study
PICS-p Longitudinal Cohort Study
Physical Functional Impairment, Cognitive Impairment
RecruitingObservational study
Post-ICU Syndrome and Social Determinants of Healths
Post-Intensive Care Syndrome (PICS)
RecruitingObservational study
Post Intensive Care Accelerometery to Study and Support Recovery Outcomes
Post Intensive Care Syndrome (PICS)
RecruitingObservational study
Post-Intensive Care Syndrome - Multicentre Prospective Registry Database of the DACH Region
PICS, PICS-F
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.
1 site 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 (PICS), run by Centre Hospitalier Universitaire Dijon at 1 site 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 8 inclusion and 13 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 Jean-Pierre QUENOT (03 80 29 36 85 ext. +33, jean-pierre.quenot@chu-dijon.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of PICS (time frame: Up to 12 months after leaving intensive care). 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 2 Oct 2025.