Status EpilepticusEpiDFANCT05246566
Assessment of Adults Epidemiological Characteristics of Status Epilepticus in the French West Indies and in French Guiana
An observational study of Status Epilepticus and Epilepsy, run by University Hospital Center of Martinique at 4 sites in France.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Status Epilepticus, Epilepsy
- What is being tested?
- Routine care
- How many people
- 241 participants
- Where
- 4 sitesFrance
- Study dates
- 15 May 2022to 30 Jan 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients covered for suspected or SE diagnosis
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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).
Trial locations and contacts
4 sites in 1 country.
Papa Gueye, PhD contact
France4 sites, 4 recruiting
- Not yet recruiting
Hospital of Basse-Terre
Basse-Terre, Guadeloupe, 97100
Julieta Quesada, MD, julieta.quesada@ch-labasseterre.fr
Julieta Quesada, MD
- Recruiting
Hospital of Cayenne
Cayenne, French Guiana, 97306
Jean-Marc Pujo, MD, jean-marc.pujo@ch-cayenne.fr
Jean-Marc Pujo, MD
- Recruiting
University Hospital Center of Martinique
Fort-de-France, Martinique, 97261
Yann Mopsus, MSc, yann.mopsus@chu-martinique.fr
Florian Negrello, MD
- Not yet recruiting
University Hospital Center of Guadeloupe
Pointe à Pitre, Guadeloupe, 97159
Patrick Portecop, MD, patrick.portecop@chu-guadeloupe.fr
Patrick Portecop, MD
About this study
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.
Read the detailed 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.
- Conditions
- Status Epilepticus, Epilepsy
- Being tested
- Routine care
- Keywords
- Status Epilepticus, Epilepsy, Epidemiology, Pronostic
- Medical subject headings
- Status Epilepticus, Epilepsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Routine careOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Routine care |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Characteristics of the patients (age, sex) / Number and percentage of patients with factors associated with SE (alcoholism, drug addiction, precarity, etc.) / Number and percentage of recurrences of SE episodes (antecedent of SE) / Number and percentage of the different causes causing a SE episode / Number and percentage of the different complications during the occurrence of a SE episode.
Measured: 15 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start15 May 2022
- Primary completion31 Oct 2024 (estimated)
- Study completion30 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 241 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Center of Martinique
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian Negrello, MD, Principal investigator, University Hospital Center of Martinique
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05246566
- Sponsor's protocol ID
- 21_RIPH3-05
- Acronym
- EpiDFA
- Status last verified
- Oct 2023
- First submitted
- 9 Feb 2022
- Last updated
- 23 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Adults Epidemiological Characteristics of Status Epilepticus in the French West Indies and in French Guiana
- ClinicalTrials.gov ID
- NCT05246566
- Acronym / sponsor ID
- EpiDFA / 21_RIPH3-05
- Conditions
- Status Epilepticus, Epilepsy
- Keywords
- Status Epilepticus, Epilepsy, Epidemiology, Pronostic
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 241 participants (estimated)
- Lead sponsor
- University Hospital Center of MartiniqueUniversity, hospital or other
- Study start
- 15 May 2022 (actual)
- Primary completion
- 31 Oct 2024 (estimated)
- Study completion
- 30 Jan 2025 (estimated)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects covered for suspected or SE diagnosis | – | Other: Routine carePatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients covered for suspected or SE diagnosis
Key inclusion criteria (9 listed)
- 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:
- 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.
Key exclusion criteria (3 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Routine careThe 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. | Other | Subjects covered for suspected or SE diagnosis |
Primary outcome
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.
Time frame: 15 months
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.
1 secondary outcome
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.
Time frame: 15 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Papa Gueye, PhD contact
Florian Negrello, MD principal investigator
University Hospital Center of Martinique
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Status Epilepticus and Epilepsy, run by University Hospital Center of Martinique at 4 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Florian Negrello, MD (05 96 55 20 15 ext. +596, florian.negrello@chu-martinique.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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. (time frame: 15 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2024.