Clinical trial NCT05491590: Patient-reported Outcome After Status Epilepticus
Official title: Patient-reported Outcomes in Status Epilepticus Requiring Intensive Care Unit Management
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Patient Reported Outcomes
Long Term Outcomes
Status Epilepticus
Intensive Care Unit
Intensive Care Unit Syndrome
Lead sponsor: Versailles Hospital
Sponsor class: OTHER
First posted: 2022-08-08
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All patients who meet the eligibility criteria will be offered participation in the 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 post-resuscitation syndrome (PICS), neuronal lesions consecutive to the SE itself or 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. Here, we propose the development of a cross-sectional collection of PROs of the different constituents of PICs and HR-QOLs, and associated with functional patient outcomes, in those who required ICU management for status epilepticus.


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

Primary outcomes:
measure: 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.
timeFrame: one day
Secondary outcomes:
measure: percentage of cognitive/physical and/or mental health impairment defined after dichotomization of i)T-MoCA ,ii) GOS, iii)IADL&ADL, iv)HAD, v)IES-r in patients managed in the ICU for or with SE
timeFrame: one day
measure: percentage of impairement of HRQoL, in 8 dimensions of the generalist of SF 36, and scores in the 7 dimensions of the specific QOLIE 31 in patients managed in intensive care for or with SE.
timeFrame: one day
measure: percentage of impairement of HRQoL, in 8 dimensions of the generalist of SF 36, and scores in the 7 dimensions of the specific QOLIE 31in the SE sub-groups defining (with or without predominant motor signs)
timeFrame: one day
measure: Presence or absence Post-ICU factors associed to the PICs, as defined above in patients managed in the ICU for or with SE.
timeFrame: one day
measure: Presence or absence of the elements associated with the PICs, as defined above, in the subgroups defining SE (SE with orwithout predominant motor signs,).
timeFrame: one day
measure: Presence or absence Post-ICU factors associated of return to work ability in patients managed in the ICU for or with SE.
timeFrame: one day
measure: score of perceived social support by the SSQ6 scale in its 2 dimensions, satisfaction and availability.
timeFrame: one day
measure: percentage of the quality of life impairement in the total population and in in the SE sub-groups patients identified with an previous epilepsy
timeFrame: one day
Other outcomes:
Locations:
city: Le Chesnay
country: France
facility: CHVersailles
state: Yvelines
city: Beuvry
country: France
facility: CH de Bethune
city: Brest
country: France
facility: CHU de Brest
city: Brive-la-Gaillarde
country: France
facility: CH de Brive la Gaillarde
city: Cannes
country: France
facility: CH de Cannes
city: Cherbourg
country: France
facility: CH du Cotentin
city: Clichy
country: France
facility: CHU de Beaujon
city: Créteil
country: France
facility: CHU Henri Mondor
city: Dijon
country: France
facility: CHU de Dijon
city: La Rochelle
country: France
facility: CH de la Rochelle
city: Melun
country: France
facility: GH Sud Ile de France
city: Nantes
country: France
facility: CHU de Nantes
city: Paris
country: France
facility: GH Paris Saint Joseph
city: Quincy-sous-Sénart
country: France
facility: Hôpital Claude Galien
city: Roanne
country: France
facility: CH de Roanne
city: Toulon
country: France
facility: CH de Toulon-La Seyne sur Mer
Study officials:
affiliation: Versailles Hospital
name: Gwenaelle JACQ, RN,MSc,PhDc
role: PRINCIPAL_INVESTIGATOR
affiliation: Versailles Hospital
name: Stephane LEGRIEL, MD,PhD
role: STUDY_DIRECTOR
References: