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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.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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
  • CHU Dijon Bourgogne

    Dijon, 21000

    Jean-Pierre QUENOT, 0380293685 ext. +33, jean-pierre.quenot@chu-dijon.fr

    Recruiting

Other trials in France

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.

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 groups in NCT06697236
Study groupRoleWhat they receive
patient90 intensive care patients
Receives: Other: EPICES score; Other: PICS evaluation
patient's relativesa 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.

  1. 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.

  1. First posted20 Nov 2024
  2. Study start26 Sep 2025
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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)
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

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.

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