Clinical Trial Details
— Status: Recruiting
Administrative data
NCT number |
NCT05246566 |
Other study ID # |
21_RIPH3-05 |
Secondary ID |
|
Status |
Recruiting |
Phase |
|
First received |
|
Last updated |
|
Start date |
May 15, 2022 |
Est. completion date |
April 30, 2024 |
Study information
Verified date |
October 2023 |
Source |
University Hospital Center of Martinique |
Contact |
Florian Negrello, MD |
Phone |
05 96 55 20 15 |
Email |
florian.negrello[@]chu-martinique.fr |
Is FDA regulated |
No |
Health authority |
|
Study type |
Observational
|
Clinical Trial Summary
The justification of this prospective and multicenter study is based on the absence of
published data concerning, status epilepticus (SE), a pathology which seems frequent in the
French West Indies (FWI) and French Guiana, and whose etiological and prognostic
characteristics are often mentioned or assumed but which remain to be demonstrated. The
scientific interest lies both in the knowledge of the epidemiology of this pathology and in
the identification of the main etiologies, in particular the underlying brain lesions.
The morbidity of SE is significant, associating neurological disorders with impaired
consciousness, respiratory, hemodynamic and cardiac rhythm disorders, as well as metabolic
disorders such as acidosis. SE-related mortality in the acute phase ranges from 3-40% across
studies and regions, while long-term mortality ranges from 17-80% depending on age, cause of
SE, comorbidities and the occurrence of complications.
The prognosis of this pathology has however improved in recent years in developed countries
or countries with a high level of health system. On the other hand, the morbidity and
mortality of SE in the French overseas departments is not known, even if these territories
are supposed to be at an equivalent level in terms of health system to that of mainland
France.
Description:
Epilepsy is a chronic neurological disease characterized by the occurrence of intermittent
seizures, often isolated, but which can progress to status epilepticus (SE) when the seizures
are repeated at short intervals without recovery of consciousness. SE is an acute
complication that occurs during epileptic disease, but it can also occur outside of known
epilepsy, indicative of acute neurological or systemic damage. SE is a neurological
emergency, the second after stroke. The incidence of the occurrence of SE is estimated at
12.6 cases per 100,000 person-year, but is widely variable depending on the study region.
The epidemiological, clinical, etiological and prognostic characteristics of epilepsy and SE
vary depending on the continent and region, mainly linked to the exposing or favoring factors
as well as the socio-economic level of the population, the healthcare offer of the patient
health system and accessibility to care for the population.
In France, the management of SE has been codified by Formalized Expert Recommendations (RFE)
from learned societies in Emergencies and Resuscitation. The last updated RFE was published
in 2018. However, very few studies have been carried out on SE in prehospital or emergencies
department. There are no national epidemiological data on SE. To our knowledge, there is no
data on the prevalence of SE in the French West Indies (FWI) and French Guiana and even less
on the main aetiologies and prognosis of this acute neurological complication.
The interest of this prospective study is to evaluate, through the emergency system, the
incidence, the modes of clinical presentation, the etiologies, the therapeutic modalities and
finally the prognosis of SE in French overseas departments. This study is of scientific
interest for the new knowledge it will bring, because there is no data concerning this
relatively common pathology in these regions.
The results of the study would contribute to the improvement of scientific knowledge, to the
highlighting of potential particularities and specificities of this pathology in the FWI and
French Guiana, and would contribute to improving medical practice and the management of these
patients.