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ClinicalTrials.gov ID

NCT06100978

Lead Sponsor

Versailles HospitalOTHER

Overall Status

Recruiting

Study Type

Observational

Enrollment

145Estimated

Last Update Posted

Jul 7, 2026Actual

Start Date

May 25, 2024Actual

Primary Completion Date

Mar 25, 2027Estimated

Completion Date

Mar 25, 2027Estimated

Official Title

Patient-reported Outcomes in Status Epilepticus Requiring Intensive Care Unit Management. A Multicenter Longitudinal Cohort Study

Brief 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. 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.

• Patient Reported Outcomes
• Patient Satisfaction
• Long Term Outcomes
• Status Epilepticus
• Intensive Care Unit
• Burden
• Relatives

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

No

Eligibility Criteria

Inclusion Criteria:

• 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

Exclusion Criteria:

• Legal guardianship
• Opposition to participate
• Unread and unwritten French language
• Patient not affiliated to a Social Security system

Observational Model

Cohort

Time Perspective

Prospective

Lead Sponsor

Versailles HospitalOTHER

mehdi.marzouk@ch-artoisternois.fr

gsboui@ch-bethune.fr

pierre.bailly@chu-brest.fr

PM.BERTRAND@ch-cannes.fr

laurent.argaud@chu-lyon.fr

jeanbaptiste.lascarrou@chu-nantes.fr

pascal.beuret@ch-roanne.fr

n.mayenco-cardenal@hopital-foch.com

jonathan.chelly@ch-toulon.fr