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

Status: Recruiting
Location: See all (13) locations...
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
CH d'Angoulême
RECRUITING
Angoulême
CH de Béthune
RECRUITING
Béthune
Hôpital Beaujon
RECRUITING
Clichy
Hôpital Henri Mondor
RECRUITING
Créteil
CHU de Dijon
RECRUITING
Dijon
CHU de Grenoble
RECRUITING
Grenoble
CH de La Rochelle
RECRUITING
La Rochelle
CH Versailles
RECRUITING
Le Chesnay
CHU de Nantes
RECRUITING
Nantes
Hôpital Paris Saint Joseph
NOT_YET_RECRUITING
Paris
CH de Roanne
RECRUITING
Roanne
Hôpital Foch
NOT_YET_RECRUITING
Suresnes
CHU Tours
NOT_YET_RECRUITING
Tours
Contact Information
Primary
Gwenaelle Jacq, RN,MSc,PhDc
gjacq@ght78sud.fr
33139638356
Time Frame
Start Date: 2024-05-25
Estimated Completion Date: 2026-07
Participants
Target number of participants: 145
Related Therapeutic Areas
Sponsors
Leads: Versailles Hospital

This content was sourced from clinicaltrials.gov