RecruitingNCT06100978

Patient-reported Outcome and Patient-reported Experience After Status Epilepticus

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


Sponsor

Versailles Hospital

Enrollment

145 participants

Start Date

May 25, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

  • 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 Criteria4

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

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Locations(13)

CH d'Angoulême

Angoulême, France

CH de Béthune

Béthune, France

Hôpital Beaujon

Clichy, France

Hôpital Henri Mondor

Créteil, France

CHU de Dijon

Dijon, France

CHU de Grenoble

Grenoble, France

CH de La Rochelle

La Rochelle, France

CH Versailles

Le Chesnay, France

CHU de Nantes

Nantes, France

Hôpital Paris Saint Joseph

Paris, France

CH de Roanne

Roanne, France

Hôpital Foch

Suresnes, France

CHU Tours

Tours, France

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NCT06100978


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