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

NCT ID: NCT06100978

Last Updated: 2024-11-05

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 145 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-05-25
• Study Completion Date: 2026-07-31

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.

Conditions

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Versailles Hospital

OTHER

Sponsor Role: lead

Responsible Party

Jacq Gwenaelle

Investigator Coordinator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gwenaelle Jacq, RN,MSc,PhDc

Role: STUDY_DIRECTOR

CH Versailles

Stephane Legriel, MD,PhD

Role: STUDY_DIRECTOR

CH Versailles

Locations

CH d'Angoulême

Angoulême, , France

Site Status: RECRUITING

CH de Béthune

Béthune, , France

Site Status: RECRUITING

Hôpital Beaujon

Clichy, , France

Site Status: RECRUITING

Hôpital Henri Mondor

Créteil, , France

Site Status: RECRUITING

CHU de Dijon

Dijon, , France

Site Status: RECRUITING

CHU de Grenoble

Grenoble, , France

Site Status: RECRUITING

CH de La Rochelle

La Rochelle, , France

Site Status: RECRUITING

CH Versailles

Le Chesnay, , France

Site Status: RECRUITING

CHU de Nantes

Nantes, , France

Site Status: RECRUITING

Hôpital Paris Saint Joseph

Paris, , France

Site Status: NOT_YET_RECRUITING

CH de Roanne

Roanne, , France

Site Status: RECRUITING

Hôpital Foch

Suresnes, , France

Site Status: NOT_YET_RECRUITING

CHU Tours

Tours, , France

Site Status: NOT_YET_RECRUITING

Countries

France

Central Contacts

Gwenaelle Jacq, RN,MSc,PhDc

Role: CONTACT

gjacq@ght78sud.fr

33139638356

Facility Contacts

David SCHNELL, MD

Role: primary

david.schnell@ch-angouleme.fr

Ghada SBOUI, MD

Role: primary

gsboui@ch-bethune.fr

Charles BERNARD, MD

Role: primary

Nicolas MONGARDON, MD

Role: primary

nicolas.mongardon@aphp.fr

Jean-Pierre QUENOT, MD

Role: primary

jean-pierre.quenot@chu-dijon.fr

Florian SIGAUD, MD

Role: primary

fsigaud@chu-grenoble.fr

Olivier LESUEUR, MD

Role: primary

olivier.lesueur@ght-atlantique.fr

Gwenaëlle JACQ, RN,MSc,PhDc

Role: primary

Stéphane LEGRIEL, MD, PhD

Role: backup

Jean-Baptiste LASCARROU, MD

Role: primary

jeanbaptiste.lascarrou@chu-nantes.fr

Cedric BRUEL, MD

Role: primary

cbruel@ghpsj.fr

Pascal BEURET, MD

Role: primary

pascal.beuret@ch-roanne.fr

Nicolas MAYENCO-CARDENAL, MD

Role: primary

n.mayenco-cardenal@hopital-foch.com

Paër-Sélim ABBACK, MD

Role: primary

p.abback@chu-tours.fr

Other Identifiers

P22/08 - POSEIDON 2

Identifier Type: -

Identifier Source: org_study_id