Clinical trial NCT03457831: Status Epilepticus in the Critically Ill Patients
Official title: Status Epilepticus in the Critically Ill Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Status Epilepticus
Lead sponsor: Ictal Group
Sponsor class: OTHER
Collaborators: name: Versailles Hospital
First posted: 2018-03-08
Enrollment: 1000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: critically ill patients requiring ICU hospitalisation

Brief summary: Convulsive and Non Convulsive Status Epilepticus (SE) and Pseudo Status Epilepticus prospective registry.

Data collection using a standardized form : demographic data and data related to the SE, including circumstances of onset, dates and times of onset and of seizure control, on-scene clinical findings, clinical features of the seizures, pre-hospital and hospital care providers, timing of antiepileptic and supportive treatments, results of etiological investigations, cause of SE, type and dosage of antiepileptic drugs. Dates and times of EEG monitoring, EEG results. Outcomes including vital status and Glasgow Outcome Scale score at ICU and hospital discharge, day-90 and 1-year after SE and determined based on data in the ICU and/or neurologist charts and/or patients phone interview.


Eligibility criteria: Inclusion Criteria:

* SE defined as 5 min or more of (i) continuous clinical and/or electrographic seizure activity or (ii) recurrent seizure activity without recovery (returning to baseline) between seizures.
* age \>= 18 years

Exclusion Criteria:

* age \< 18 years
* postanoxic status epilepticus

Primary outcomes:
measure: Favorable outcome
timeFrame: 1 year
Secondary outcomes:
measure: Favorable outcome
timeFrame: 3 months, 5-years and 10 years
measure: Functional impairment
timeFrame: 3 months, and 1-year, 5-years and 10-years
measure: total seizure duration
timeFrame: 72 hours
measure: percentages of the patients that experience recurrent convulsive and/or non-convulsive seizures within 12 hours after ICU admission
timeFrame: 12 hours
measure: refractory status epilepticus
timeFrame: 24 hours
measure: super refractory status epilepticus
timeFrame: 72 hours
measure: total ICU and in-hospital length of stay
timeFrame: 90 days
measure: mortality rate
timeFrame: ICU and hospital discharge, 3-months, and 1-year, 5 years and 10 years
Other outcomes:
Locations:
city: Angoulême
country: France
facility: CH Angouleme - Service de réanimation polyvalente
city: Beauvais
country: France
facility: CH de Beauvais - Service de réanimation polyvalente
city: Beuvry
country: France
facility: CH de Bethune - Service de Réanimation et Surveillance continue
city: Brest
country: France
facility: Centre Hospitalier Universitaire Régional
city: Brive-la-Gaillarde
country: France
facility: CH Brive La Gaillarde - Service de réanimation - USC
city: Cannes
country: France
facility: CH de Cannes
city: Cherbourg
country: France
facility: CH Public du Cotentin - Service de Réanimation - Médecin intensive
city: Clichy
country: France
facility: CHU Beaujon
city: Créteil
country: France
facility: Hopitaux Universitaires Henri Mondor - Service d'anesthésie et des réanimations chirurgicales, Unité d'anesthésie-réanimation chirurgical cardiovasculaire
city: Dieppe
country: France
facility: Centre Hospitalier de Dieppe
city: Dijon
country: France
facility: Centre Hospitalier Universitaire de Dijon
city: La Rochelle
country: France
facility: CH de La Rochelle - Service de réanimation - USC
city: Le Chesnay
country: France
facility: Intensive Care Unit - Versailles Hospital
city: Massy
country: France
facility: Hôpital privé Jacques Cartier - Service de réanimation médico chirurgicale
city: Melun
country: France
facility: Groupe Hospitalier Sud Ile de France - Service de Réanimation - Médecin intensive
city: Nantes
country: France
facility: Centre Hospitalier Universitaire de Nantes
city: Paris
country: France
facility: Groupe Hospitalier Paris Saint Joseph - Service de réanimation médico chirurgicale
city: Quincy-sous-Sénart
country: France
facility: HP Claude Galien - Service de Réanimation Polyvalente
city: Roanne
country: France
facility: Centre hospitalier de Roanne - Service de Réanimation - Soins continus
city: Toulon
country: France
facility: Centre Hospitalier de Toulon
Study officials:
affiliation: Ictal Group
name: stephane LEGRIEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Jacq G, Chelly J, Quenot JP, Soulier P, Lesieur O, Beuret P, Holleville M, Bruel C, Bailly P, Sauneuf B, Sejourne C, Rigaud JP, Galbois A, Arrayago M, Plantefeve G, Stoclin A, Schnell D, Fontaine C, Perier F, Bougouin W, Pichon N, Mongardon N, Ledoux D, Lascarrou JB, Legriel S. Multicentre observational status-epilepticus registry: protocol for ICTAL. BMJ Open. 2022 Feb 15;12(2):e059675. doi: 10.1136/bmjopen-2021-059675.