Assessment of Adults Epidemiological Characteristics of Status Epilepticus in the French West Indies and in French Guiana
EpiDFA
1 other identifier
observational
241
1 country
4
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2022
Typical duration for all trials
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 9, 2022
CompletedFirst Posted
Study publicly available on registry
February 18, 2022
CompletedStudy Start
First participant enrolled
May 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 31, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
January 30, 2025
CompletedAugust 23, 2024
October 1, 2023
2.5 years
February 9, 2022
August 22, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To measure the annual incidence rate of occurrence of status epilepticus (SE) in adults treated by SAMU/SMUR and emergency services in the French West Indies and French Guiana.
The incidence rate of the occurrence of SE expressed per 100,000 person-years.This incidence rate will be calculated by dividing the number of new cases of SE during the 12 months of the inclusion phase of the study by the estimate of the average number of inhabitants aged 18 and over in each region of inclusion.
15 months
Secondary Outcomes (1)
To describe the epidemiological characteristics of status epilepticus in adults in the French West Indies and French Guiana in terms of patient profiles, associated factors, recurrences, causes and complications.
15 months
Other Outcomes (2)
To describe the neurological evolution 30 days and 90 days after the SE eoisode in adults in the French West Indies and French Guiana.
15 months
To measure the mortality rate at day 1, day 30 and day 90 after the onset of SE in adults treated by SAMU/SMUR and emergency services in the French West Indies and French Guiana.
15 months
Study Arms (1)
Subjects covered for suspected or SE diagnosis
Patients covered for suspected or SE diagnosis defined by one of the following: * a prolonged generalized tonic-clonic crisis lasting more than 5 minutes and accompanied by impaired consciousness or at least 2 generalized tonic-clonic crisis without return to normal consciousness between crisis. * a focal convulsive crisis (motor or not) with disturbances of consciousness which lasts beyond 10 minutes or crisis which are repeated (≥ 2) at short intervals without recovery of interictal consciousness. * a focal convulsive crisis (motor or not) without alteration of consciousness that lasts beyond 10 to 15 minutes. * an absence-type crisis that lasts longer than 10 to 15 minutes. * a myoclonic, clonic and tonic crisis that lasts longer than 10 to 15 minutes. * a coma with an epileptic cause diagnosed on an EEG.
Interventions
The investigator takes care of the patient according to the protocol in force in his department and decides on the final orientation of the patient (transfer to intensive care unit/ICU, hospitalization or home discharge). No recommendations or instructions are given to the investigators. Each investigator is free to decide on his care and the terms of transfer, hospitalization and discharge.
Eligibility Criteria
Adult patients covered for suspected or SE diagnosis
You may qualify if:
- Adult patients (≥ 18 years old) treated for SE by SAMU/SMUR and by emergencies or intensive care in the French West Indies and French Guiana.
- Covered for suspected or SE diagnosis defined by one of the following:
- a prolonged generalized tonic-clonic crisis lasting more than 5 minutes and accompanied by impaired consciousness or at least 2 generalized tonic-clonic crisis without return to normal consciousness between crisis.
- a focal convulsive crisis (motor or not) with disturbances of consciousness which lasts beyond 10 minutes or crisis which are repeated (≥ 2) at short intervals without recovery of interictal consciousness.
- a focal convulsive crisis (motor or not) without alteration of consciousness that lasts beyond 10 to 15 minutes.
- an absence-type crisis that lasts longer than 10 to 15 minutes.
- a myoclonic, clonic and tonic crisis that lasts longer than 10 to 15 minutes.
- a coma with an epileptic cause diagnosed on an EEG.
- Patient if he is able to, or representative of the patient in case of incapacity, having given his agreement for the use of his medical data for this research.
You may not qualify if:
- Age \< 18 years old
- Absence of consent from the patient, or representative to the use of the data for the research.
- Patient whose main residence is not in the department where the study is taking place (vacationer for example).
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Hospital of Cayenne
Cayenne, French Guiana, 97306, France
Hospital of Basse-Terre
Basse-Terre, Guadeloupe, 97100, France
University Hospital Center of Guadeloupe
Pointe à Pitre, Guadeloupe, 97159, France
University Hospital Center of Martinique
Fort-de-France, Martinique, 97261, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Florian Negrello, MD
University Hospital Center of Martinique
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 9, 2022
First Posted
February 18, 2022
Study Start
May 15, 2022
Primary Completion
October 31, 2024
Study Completion
January 30, 2025
Last Updated
August 23, 2024
Record last verified: 2023-10
Data Sharing
- IPD Sharing
- Will not share