Post Intensive Care SyndromeSTRESSréaNCT06308835
Prevalence and Risk Factor of Post-intensive Care Syndrome in Neuro-ICU
An observational study of Post Intensive Care Syndrome, run by Assistance Publique - Hôpitaux de Paris at 2 sites in France.
Trial summary
Post-intensive care syndrome (PICS) is the set of disabling symptoms that can appear or worsen following a stay in intensive care. These symptoms are physical, cognitive, or psychiatric. 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?
- questionnaires
- How many people
- 100 participants
- Where
- 2 sitesFrance
- Study dates
- May 2024to Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: patients hospitalized in a medical intensive care unit with a neurological disease affecting the central or peripheral nervous system, which is the reason for their hospitalization in an intensive care unit,
Who may be able to join
- 1. Patient with > 24h stay in intensive care unit
- 2.Patients with a neurological disease affecting the central or peripheral nervous system, which is the reason for their hospitalization in intensive care.
- 3. Patients who have received organ replacement or invasive therapy in the ICU (invasive or non-invasive ventilation, extra-renal purification, plasmapheresis, ventricular bypass, catecholamines).
- 4. Non-opposition of the patient or of the trusted support person, or of a family member or close friend if the patient is unable to express non-opposition.
Who cannot join
- 1. Minors, protected adults and pregnant women
- 2. Advanced neurodegenerative disease pre-existing prior to ICU admission
- 3. Severe psychotic disorders pre-existing before admission to intensive care
- 4. Patients whose neurological and psychiatric history is unknown prior to resuscitation
Trial locations and contacts
2 sites in 1 country.
France2 sites
GH Pitié Salpêtrière
Paris, 75013
Clémence Marois, MD, MSc, 0142161858 ext. 33, clemence.marois@aphp.fr
CH Saint Anne
Paris, 75014
Camille Legouy, MD, 0145656200 ext. 33, c.legouy@ghu-paris.fr
About this study
Official title: Prevalence and Risk Factors of Post Intensive Care Syndrome at 3 Months of an Intensive Care Unit Stay for a Neurological Disease
Post-intensive care syndrome (PICS) is the set of disabling symptoms that can appear or worsen following a stay in intensive care. These symptoms are physical, cognitive, or psychiatric. The onset and persistence of these symptoms have a major impact on patients' quality of life, their autonomy, and their social and professional reintegration. patients with neurological diseases are frequently excluded from studies due to difficulties for the non-specialist resuscitator to perform the neurological examination and assess whether the symptoms of RPS are secondary to brain damage or complications inherent in resuscitation.The aim of this study is to evaluate the incidence and characteristics of PICS in patients with neurological diseases, at ICU discharge and 3 months after, and to identify the risk factors for developing it.
Read the detailed description
"Post-intensive care syndrome (PICS) is defined as a new or worsening impairment in physical, cognitive or mental health status arising and persisting after a stay in intensive care unit (ICU) . The onset and persistence of these symptoms have a major impact on patients' quality of life, their autonomy, and their social and professional reintegration. PICS is very common, and more than half of ICU adult patients experience such impairments.
Recent French guidelines about PICS have been published and implemented to raise awareness among clinicians and patients about diagnosis and management of PICS .
A systematic ICU follow-up consultation by trained practitioners allows the diagnosis of PICS, and the implementation of appropriate curative measures to minimize sequelae and improve outcomes . This consultation is increasingly recommended by learned societies.
Incidence and risk factors of PICS is poorly known in patients with neurological diseases, because they are frequently excluded from PICS studies due to difficulties to assess whether the symptoms are disease-related or directly associated with the experience of a critical illness. A better knowledge of follow up of these patients is necessary to identify if some neurocognitive sequelae may be preventable or treatable.
The aim of this study is to evaluate the incidence and characteristics of PICS in patients with neurological diseases, at ICU discharge and 3 months after, and to identify the risk factors for developing it.
The investigators wish to conduct a bi-centric prospective study, in two neurological ICU in Paris (AP-HP Sorbonne université - Pitié Salpetrière hospital and Paris Cité -Saint Anne Hospital). The study will last one year.
It will included adults patients hospitalized >24h in neuro-ICU for a neurological disease affecting the central nervous system (status epilepticus, encephalitis, subarachnoid haemorrhage…) or the peripheral nervous system (myasthenia gravis crisis, Guillain-Barre syndrome…) ; and having received ICU lifesaving treatments (mechanical ventilation; sedation; plasmapheresis, renal replacement therapy, catecholamine).
Were excluded pregnant women, patients with pre-existing neurodegenerative disease or pre-existing severe psychiatric illness, and patients whose neurological or psychiatric history were not known prior to ICU. Patients with blindness, deafness, inability to speak French, active substance abuse, homelessness, or who lived > 100 kilometers from the enrolling center.
Patients will be recruited at the end of the ICU stay, patient's non-opposition will be collected. If the patient is unable to consent, the non-opposition of the person of trust will be collected.
As close as possible to the ICU discharge, a neurological examination, a MRC score, a MOCA scale, and a HADS scale will be performed.
The ICU-follow up visit will be planned 3 months +- 30 days from the ICU discharge and will include:
- An interview conducted by a trained neuro-intensivist with assessment of neurological symptoms and autonomy assessed by the Glasgow Outcome Scale extended (GOS-e), and the modified Rankin Scale (mRS), of psychiatric symptoms with self-reported questionnaires: Hospital Anxiety and Depression Scale (HADS) and the impact of event scale (IES-R).
- A physical assessement by a physiotherapist including a Medical research coucil score (MRC)
- A neuropsychological assessement by a neuropsychologist including a Montreal Cognitive Assessment (MOCA), batterie d'efficience frontale (BREF), Symbol Digit Modalities Test (SDMT), Trail Making Test (TMT), Empans verbaux, Boston naming Test (BNT)
- Conditions
- Post Intensive Care Syndrome
- Being tested
- questionnaires
- 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.
questionnairesOther
BREF(Batterie d'efficience Frontale), SDMT (Symbol Digit Modalities Test), TMT (Trail making test), Empans verbaux et BNT (Boston naming Test)
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a physical symptom
defined by the presence of an MRC (Medical Research Council) score <48/60 (higher score mean better outcome)
Measured: 3 months
Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a cognitive symptom
defined by a MOCA (Montreal Cognitive Assessment) <26/30 (higher score mean better outcome)
Measured: 3 months
Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a psychological symptom
defined by a Hospital Anxiety and Depression Scale (HADS) score A or D > 8 (ranging frome 0 to 21, lower score mean better outcome)
Measured: 3 months
Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a psychological symptom.
defined by an Impact of Events Scale (IESR) > 22 (ranging from 0 to 88, lower score mean better outcome)
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2024
- Study startMay 2024 (estimated)
- Primary completionAug 2025 (estimated)
- Study completionAug 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 Assistance Publique - Hôpitaux de ParisThe 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Clémence Marois, MD, MSc, Principal investigator, Assisitance Publique des Hôpitaux de Paris
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06308835
- Sponsor's protocol ID
- APHP231652
- Acronym
- STRESSréa
- Status last verified
- Mar 2024
- First submitted
- 5 Mar 2024
- Last updated
- 18 Mar 2024
- 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 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence and Risk Factors of Post Intensive Care Syndrome at 3 Months of an Intensive Care Unit Stay for a Neurological Disease
- ClinicalTrials.gov ID
- NCT06308835
- Acronym / sponsor ID
- STRESSréa / APHP231652
- Conditions
- Post Intensive Care Syndrome
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- May 2024 (estimated)
- Primary completion
- Aug 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 13 Mar 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.
Post-intensive care syndrome (PICS) is the set of disabling symptoms that can appear or worsen following a stay in intensive care. These symptoms are physical, cognitive, or psychiatric. The onset and persistence of these symptoms have a major impact on patients' quality of life, their autonomy, and their social and professional reintegration. patients with neurological diseases are frequently excluded from studies due to difficulties for the non-specialist resuscitator to perform the neurological examination and assess whether the symptoms of RPS are secondary to brain damage or complications inherent in resuscitation.The aim of this study is to evaluate the incidence and characteristics of PICS in patients with neurological diseases, at ICU discharge and 3 months after, and to identify the risk factors for developing it.
Detailed description
"Post-intensive care syndrome (PICS) is defined as a new or worsening impairment in physical, cognitive or mental health status arising and persisting after a stay in intensive care unit (ICU) . The onset and persistence of these symptoms have a major impact on patients' quality of life, their autonomy, and their social and professional reintegration. PICS is very common, and more than half of ICU adult patients experience such impairments.
Recent French guidelines about PICS have been published and implemented to raise awareness among clinicians and patients about diagnosis and management of PICS .
A systematic ICU follow-up consultation by trained practitioners allows the diagnosis of PICS, and the implementation of appropriate curative measures to minimize sequelae and improve outcomes . This consultation is increasingly recommended by learned societies.
Incidence and risk factors of PICS is poorly known in patients with neurological diseases, because they are frequently excluded from PICS studies due to difficulties to assess whether the symptoms are disease-related or directly associated with the experience of a critical illness. A better knowledge of follow up of these patients is necessary to identify if some neurocognitive sequelae may be preventable or treatable.
The aim of this study is to evaluate the incidence and characteristics of PICS in patients with neurological diseases, at ICU discharge and 3 months after, and to identify the risk factors for developing it.
The investigators wish to conduct a bi-centric prospective study, in two neurological ICU in Paris (AP-HP Sorbonne université - Pitié Salpetrière hospital and Paris Cité -Saint Anne Hospital). The study will last one year.
It will included adults patients hospitalized >24h in neuro-ICU for a neurological disease affecting the central nervous system (status epilepticus, encephalitis, subarachnoid haemorrhage…) or the peripheral nervous system (myasthenia gravis crisis, Guillain-Barre syndrome…) ; and having received ICU lifesaving treatments (mechanical ventilation; sedation; plasmapheresis, renal replacement therapy, catecholamine).
Were excluded pregnant women, patients with pre-existing neurodegenerative disease or pre-existing severe psychiatric illness, and patients whose neurological or psychiatric history were not known prior to ICU. Patients with blindness, deafness, inability to speak French, active substance abuse, homelessness, or who lived > 100 kilometers from the enrolling center.
Patients will be recruited at the end of the ICU stay, patient's non-opposition will be collected. If the patient is unable to consent, the non-opposition of the person of trust will be collected.
As close as possible to the ICU discharge, a neurological examination, a MRC score, a MOCA scale, and a HADS scale will be performed.
The ICU-follow up visit will be planned 3 months +- 30 days from the ICU discharge and will include:
- An interview conducted by a trained neuro-intensivist with assessment of neurological symptoms and autonomy assessed by the Glasgow Outcome Scale extended (GOS-e), and the modified Rankin Scale (mRS), of psychiatric symptoms with self-reported questionnaires: Hospital Anxiety and Depression Scale (HADS) and the impact of event scale (IES-R).
- A physical assessement by a physiotherapist including a Medical research coucil score (MRC)
- A neuropsychological assessement by a neuropsychologist including a Montreal Cognitive Assessment (MOCA), batterie d'efficience frontale (BREF), Symbol Digit Modalities Test (SDMT), Trail Making Test (TMT), Empans verbaux, Boston naming Test (BNT)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- patients hospitalized in a medical intensive care unit with a neurological disease affecting the central or peripheral nervous system, which is the reason for their hospitalization in an intensive care unit,
Key inclusion criteria (4 listed)
- 1. Patient with > 24h stay in intensive care unit
- 2.Patients with a neurological disease affecting the central or peripheral nervous system, which is the reason for their hospitalization in intensive care.
- 3. Patients who have received organ replacement or invasive therapy in the ICU (invasive or non-invasive ventilation, extra-renal purification, plasmapheresis, ventricular bypass, catecholamines).
- 4. Non-opposition of the patient or of the trusted support person, or of a family member or close friend if the patient is unable to express non-opposition.
Key exclusion criteria (4 listed)
- 1. Minors, protected adults and pregnant women
- 2. Advanced neurodegenerative disease pre-existing prior to ICU admission
- 3. Severe psychotic disorders pre-existing before admission to intensive care
- 4. Patients whose neurological and psychiatric history is unknown prior to resuscitation
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 |
|---|---|---|
| questionnairesBREF(Batterie d'efficience Frontale), SDMT (Symbol Digit Modalities Test), TMT (Trail making test), Empans verbaux et BNT (Boston naming Test) | Other | – |
Primary outcome
Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a physical symptom
Time frame: 3 months
defined by the presence of an MRC (Medical Research Council) score <48/60 (higher score mean better outcome)
Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a cognitive symptom
Time frame: 3 months
defined by a MOCA (Montreal Cognitive Assessment) <26/30 (higher score mean better outcome)
Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a psychological symptom
Time frame: 3 months
defined by a Hospital Anxiety and Depression Scale (HADS) score A or D > 8 (ranging frome 0 to 21, lower score mean better outcome)
Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a psychological symptom.
Time frame: 3 months
defined by an Impact of Events Scale (IESR) > 22 (ranging from 0 to 88, lower score mean better outcome)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2024.
- 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. This study is not recruiting at the moment.
Clémence Marois, MD, MSc principal investigator
Assisitance Publique des Hôpitaux de Paris
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 Assistance Publique - Hôpitaux de Paris 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 4 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 18 Mar 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marois Clémence, MD, MSc (0142161858 ext. +33, clemence.marois@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluate the presence at 3 months of discharge from an ICU stay for neurological disease of a post intensive care syndrome defined as a physical symptom (time frame: 3 months). The study lists 4 primary outcomes in all. 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 2024.