Patient Reported OutcomesPOSEIDON2NCT06100978
Patient-reported Outcome and Patient-reported Experience After Status Epilepticus
An observational study of Patient Reported Outcomes and Patient Satisfaction, run by Versailles Hospital at 19 sites in France.
Trial summary
Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Patient Reported Outcomes, Patient Satisfaction, Long Term Outcomes
- How many people
- 145 participants
- Where
- 19 sitesFrance
- Study dates
- 25 May 2024to 25 Mar 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
- No healthy volunteers
- Adult, Older adult
Study population: All patients who meet the eligibility criteria will be offered participation in the study.
Who may be able to join
- Adults 18 years old or older
- Patients previously included in the ICTAL registry (Status Epilepticus cohort NCT03457831)
- Survivors after ICU management for Status Epilepticus More than 3 months and less than 5 years after ICU discharge
Who cannot join
- Legal guardianship
- Opposition to participate
- Unread and unwritten French language
- Patient not affiliated to a Social Security system
Trial locations and contacts
19 sites in 1 country. Contact the study team or a site near you to ask about taking part.
19 sites in 1 country
France19 sites, 16 recruiting
- Recruiting
CH d'Angoulême
Angoulême
David SCHNELL, MD, david.schnell@ch-angouleme.fr
- Not yet recruiting
CH d'Arras
Arras
Mehdi MARZOUK, MD, mehdi.marzouk@ch-artoisternois.fr
- Active, not recruiting
CHU de Besançon
Besançon
- Recruiting
CH de Béthune
Béthune
Ghada SBOUI, MD, gsboui@ch-bethune.fr
- Recruiting
CHU de Brest
Brest
Pierre BAILLY, MD, pierre.bailly@chu-brest.fr
- Recruiting
CH de Cannes
Cannes
Pierre-Marie BERTRAND, MD, PM.BERTRAND@ch-cannes.fr
- Recruiting
Hôpital Beaujon
Clichy
Charles BERNARD, MD
- Recruiting
Hôpital Henri Mondor
Créteil
Nicolas MONGARDON, MD, nicolas.mongardon@aphp.fr
- Active, not recruiting
CHU de Dijon
Dijon
- Recruiting
CHU de Grenoble
Grenoble
Florian SIGAUD, MD, fsigaud@chu-grenoble.fr
- Recruiting
CH de La Rochelle
La Rochelle, 17019
Olivier LESIEUR, MD, olivier.lesueur@ght-atlantique.fr
- Recruiting
CH Versailles
Le Chesnay
Gwenaëlle JACQ, RN,MSc,PhDc
Stéphane LEGRIEL, MD, PhD
- Recruiting
CHU de Lyon
Lyon
Laurent ARGAUD, MD, laurent.argaud@chu-lyon.fr
- Recruiting
CHU de Nantes
Nantes
Jean-Baptiste LASCARROU, MD, jeanbaptiste.lascarrou@chu-nantes.fr
- Recruiting
Hôpital Paris Saint Joseph
Paris
Cedric BRUEL, MD, cbruel@ghpsj.fr
- Recruiting
CH de Roanne
Roanne
Pascal BEURET, MD, pascal.beuret@ch-roanne.fr
- Recruiting
Hôpital Foch
Suresnes
Nicolas MAYENCO-CARDENAL, MD, n.mayenco-cardenal@hopital-foch.com
- Recruiting
CH de Toulon
Toulon
Jonathan CHELLY, MD, jonathan.chelly@ch-toulon.fr
- Active, not recruiting
CHU Tours
Tours
About this study
Official title: Patient-reported Outcomes in Status Epilepticus Requiring Intensive Care Unit Management. A Multicenter Longitudinal Cohort Study
Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. The proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory SE. Morbidity is more difficult to evaluate, as adverse effects of SE are often difficult to differentiate from those attributed to the cause of SE. Our experience suggests that nearly 50% of patients may experience long-term functional impairments. The precise description of the consequences of these functional impairments and their impact on quality of life after SE requiring intensive care management has been little studied. Indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term postresuscitation syndrome (PICS), neuronal lesions consecutive to the SE itselfor to its cause could be responsible for these different functional alterations.
Thus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress.
Assessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. The POSEIDON study was a cross-sectional collection of PROs and HR-QOL components, and associated with patient functional outcomes, in those who required ICU management for status epilepticus. We propose here to continue the description of potential alterations after a subsequent ME, namely a longitudinal study (POSEIDON 2) which will also include the evaluation of patient-reported experience (PREMS) and the measurement of family burden.
- Conditions
- Patient Reported Outcomes, Patient Satisfaction, Long Term Outcomes, Status Epilepticus, Intensive Care Unit, Burden
- Medical subject headings
- Patient Satisfaction, Status Epilepticus
What is being measured
The primary outcome is the main question the study is designed to answer.
percentage of global impairment of HRQoL
percentage of global impairment of HRQoL defined by one and/or other of the physical and mental impairments (after dichotomization of the SF 36 summary scores compared to the general population) in patients managed in the ICU for or with SE. 36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score[0-100], a high score indicate better health status.
Measured: at 3 month and 12 month
Secondary outcomes (9)
percentage of cognitive impairment in patients managed in the ICU for or with SE
i)The cognitive complaints questionnaire (Questionnaire de Plainte Cognitive (QPC)(Cognition)- a score=3 or more indicate cognitive complaints
Measured: at 3 month and 12 month
percentage of disability in patients managed in the ICU for or with SE
The Glasgow Outcome Scale extended (Handicap)-Ranging score[1-8] a hight score indicate no handicap A score of 5 to 8 on the GOSE indicate a favorable outcome
Measured: at 3 month and 12 month
percentage of physical dependency in patients managed in the ICU for or with SE
The Lawton IADL (scale contains eight items, with a summary score from 0 (low function) to 8 (high function).and Barthel index (Dependency)-Ranging score[0-100], a high score indicate no dependency.
Measured: at 3 month and 12 month
percentage of anxiety and depression in patients managed in the ICU for or with SE
The Hospital anxiety and depression (Anxiety,Depression)-Ranging score[0-21] a score > 8 indicate in each subscale a depresion or/and anxiety
Measured: at 3 month and 12 month
percentage of post traumatic syndrome disorder in patients managed in the ICU for or with SE
The Impact of Event Scale -Revised(post traumatic syndrome disorder)-Ranging score[0-88],scores higher than 24 are of concern; the higher scores indicate the severity of PTSD
Measured: at 3 month and 12 month
score of perceived social support by the SSQ6 scale in its 2 dimensions, satisfaction and availability.
The Social Support Questionnaire- Short Form-SSQ6 / 6 item measure of social support, with scores ranging from 0 (no social support) to 6 (very high social) and 1 (very dissatisfied) to 6 (very satisfied) for the area of satisfaction in each item or area. From these scores in the 6 domains, an average score with the support given in each of the areas.
Measured: at 3 month and 12 month
Presence or absence Post-ICU factors associated of return to work ability in patients managed in the ICU for or with SE.
A return to work will be interpreted by measured by the Work Productivity and Activity Impairment Questionnaire: General Health (WPAI-GH scale)
The WPAI-GH consists of six questions: 1 = currently employed; 2 = hours missed due to health problems; 3 = hours missed other reasons; 4 = hours actually worked; 5 = degree health affected productivity while working (using a 0 to 10 Visual Analogue Scale (VAS)); 6 = degree health affected productivity in regular unpaid activities (VAS).. Four main outcomes can be generated from the WPAI-GH and expressed in percentages by multiplying the following scores by 100:
Measured: at 3 month and 12 month
patient's experience of the care system.
Score measured by the PPE 15 (Picker Patient Experience Questionnaire) of the patient's experience of the healthcare system.
It consists of 15 questions distributed to seven dimensions of care: respect, coordination, information/communication/education, physical comfort, emotional support, involvement of relatives, and transitions and continuity The questions have two ("yes" or "no") to four response options ("yes"," no", "I did not need to", or "yes, to some extent"). Neutral answers, such as "I did not need to", and the most positive answer are coded as a "non-problem" (score = 0). The remaining responses are coded as "problems" (score = 1).
Measured: at 3 month and 12 month
experience of the patient's relative at M3 and M12 of discharge from intensive care following management with or for a patient's ME.
Score measured by ZARIT scale Zarit Burden Interview: Revised (22-items) Total score range: 0 to 88 0-21: no to mild burden 21-40: mild to moderate burden 41-60: moderate to severe burden ≥ 61: severe burden
Measured: at 3 month and 12 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2023
- Study start25 May 2024
- Primary completion25 Mar 2027 (estimated)
- Study completion25 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Patient Reported OutcomesStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 145 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Versailles Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacq Gwenaelle, Versailles Hospital
- Investigators
- Gwenaelle Jacq, RN,MSc,PhDc, Study director, CH VersaillesStephane Legriel, MD,PhD, Study director, CH Versailles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06100978
- Sponsor's protocol ID
- P22/08 - POSEIDON 2
- Acronym
- POSEIDON2
- Status last verified
- Jul 2026
- First submitted
- 15 Oct 2023
- Last updated
- 7 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Legriel S, Bernard C, Sboui G, Sigaud F, Lascarrou JB, Mayenco-Cardenal N, Chelly J, Bruel C, Mongardon N, Marzouk M, Quenot JP, Hugues R, Schnell D, Beuret P, Bailly P, Lesieur O, Argaud L, Chambon R, Jacq G. Assessment of health-related quality of life, cognitive, physical and psychological impairments in critically ill adults after status epilepticus (POSEIDON 2): protocol for a multicentre longitudinal study. BMJ Open. 2026 Mar 3;16(3):e112563. doi: 10.1136/bmjopen-2025-112563.
PubMed 41775483
Study at a glance
From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Patient-reported Outcomes in Status Epilepticus Requiring Intensive Care Unit Management. A Multicenter Longitudinal Cohort Study
- ClinicalTrials.gov ID
- NCT06100978
- Acronym / sponsor ID
- POSEIDON2 / P22/08 - POSEIDON 2
- Conditions
- Patient Reported Outcomes, Patient Satisfaction, Long Term Outcomes, Status Epilepticus, Intensive Care Unit, Burden
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 145 participants (estimated)
- Lead sponsor
- Versailles HospitalUniversity, hospital or other
- Study start
- 25 May 2024 (actual)
- Primary completion
- 25 Mar 2027 (estimated)
- Study completion
- 25 Mar 2027 (estimated)
- First posted
- 25 Oct 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.
Status epilepticus (SE) is a common life-threatening neurological emergency in which prolonged or multiple closely spaced seizures can result in long-term impairments. SE remains associated with considerable mortality and morbidity, with little progress over the last three decades. The proportion of patients who die in the hospital is about 20% overall and 40% in patients with refractory SE. Morbidity is more difficult to evaluate, as adverse effects of SE are often difficult to differentiate from those attributed to the cause of SE. Our experience suggests that nearly 50% of patients may experience long-term functional impairments. The precise description of the consequences of these functional impairments and their impact on quality of life after SE requiring intensive care management has been little studied. Indeed, if cognitive, physical and mental impairments are now identified in the populations of patients who required intensive care under the term postresuscitation syndrome (PICS), neuronal lesions consecutive to the SE itselfor to its cause could be responsible for these different functional alterations.
Thus, the following have been described: (i) cognitive disorders in the areas of attention, executive functions and verbal fluency, visual and working memory disorders, but also spatio-temporal disorders; (ii) physical disorders such as the so-called post-resuscitation polyneuromyopathy; and (iii) mental disorders such as anxiety disorders, depressive states or those related to post-traumatic stress.
Assessment and characterization of patient-reported outcomes is essential to complement the holistic assessment of clinically relevant outcomes from the patient's perspective. The POSEIDON study was a cross-sectional collection of PROs and HR-QOL components, and associated with patient functional outcomes, in those who required ICU management for status epilepticus. We propose here to continue the description of potential alterations after a subsequent ME, namely a longitudinal study (POSEIDON 2) which will also include the evaluation of patient-reported experience (PREMS) and the measurement of family burden.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients who meet the eligibility criteria will be offered participation in the study.
Key inclusion criteria (3 listed)
- Adults 18 years old or older
- Patients previously included in the ICTAL registry (Status Epilepticus cohort NCT03457831)
- Survivors after ICU management for Status Epilepticus More than 3 months and less than 5 years after ICU discharge
Key exclusion criteria (4 listed)
- Legal guardianship
- Opposition to participate
- Unread and unwritten French language
- Patient not affiliated to a Social Security system
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
percentage of global impairment of HRQoL
Time frame: at 3 month and 12 month
percentage of global impairment of HRQoL defined by one and/or other of the physical and mental impairments (after dichotomization of the SF 36 summary scores compared to the general population) in patients managed in the ICU for or with SE. 36-Item Short Form Survey (SF-36) (HRQoL)-Ranging score[0-100], a high score indicate better health status.
9 secondary outcomes
percentage of cognitive impairment in patients managed in the ICU for or with SE
Time frame: at 3 month and 12 month
percentage of disability in patients managed in the ICU for or with SE
Time frame: at 3 month and 12 month
percentage of physical dependency in patients managed in the ICU for or with SE
Time frame: at 3 month and 12 month
percentage of anxiety and depression in patients managed in the ICU for or with SE
Time frame: at 3 month and 12 month
percentage of post traumatic syndrome disorder in patients managed in the ICU for or with SE
Time frame: at 3 month and 12 month
score of perceived social support by the SSQ6 scale in its 2 dimensions, satisfaction and availability.
Time frame: at 3 month and 12 month
Presence or absence Post-ICU factors associated of return to work ability in patients managed in the ICU for or with SE.
Time frame: at 3 month and 12 month
patient's experience of the care system.
Time frame: at 3 month and 12 month
experience of the patient's relative at M3 and M12 of discharge from intensive care following management with or for a patient's ME.
Time frame: at 3 month and 12 month
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 7 Jul 2026.
- Derived from this study: PubMed 41775483Legriel S, Bernard C, Sboui G, Sigaud F, Lascarrou JB, Mayenco-Cardenal N, Chelly J, Bruel C, Mongardon N, Marzouk M, Quenot JP, Hugues R, Schnell D, Beuret P, Bailly P, Lesieur O, Argaud L, Chambon R, Jacq G. Assessment of health-related quality of life, cognitive, physical and psychological impairments in critically ill adults after status epilepticus (POSEIDON 2): protocol for a multicentre longitudinal study. BMJ Open. 2026 Mar 3;16(3):e112563. doi: 10.1136/bmjopen-2025-112563.
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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.
Gwenaelle Jacq, RN,MSc,PhDc study director
CH Versailles
Stephane Legriel, MD,PhD study director
CH Versailles
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Reported Outcomes and Patient Satisfaction, run by Versailles Hospital at 19 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 3 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: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 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 Gwenaelle Jacq, RN,MSc,PhDc (33139638356, gjacq@ght78sud.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
percentage of global impairment of HRQoL (time frame: at 3 month and 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06100978, which also lists 1 linked publication.
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 7 Jul 2026.