Status Epilepticus in the Critically Ill Patients

Recruiting

• Conditions: Status Epilepticus

• Registration Number: NCT03457831
• Lead Sponsor: Ictal Group

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-02-28
• Study First Submitted: 2018-02-28
• Study First Submitted QC: 2018-03-06
• Study First Posted: 2018-03-08
• Status Verified: 2020-10
• Last Update Submitted: 2020-10-20
• Last Update Posted: 2020-10-22
• Primary Completion: 2028-12-31
• Study Completion: 2028-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Favorable outcome	1 year	A favorable outcome is defined by a Glasgow Outcome Scale (GOS) of 5. The Glasgow Outcome Scale (GOS) will be determined according to patients charts review and/or general practitioner interview conducted by an independent assessor. The GOS score : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]

Secondary Outcome Measures

Name	Time	Method
refractory status epilepticus	24 hours
super refractory status epilepticus	72 hours
total ICU and in-hospital length of stay	90 days	total ICU and in-hospital length of stay in days
mortality rate	ICU and hospital discharge, 3-months, and 1-year, 5 years and 10 years
Favorable outcome	3 months, 5-years and 10 years	A favorable outcome is defined by a Glasgow Outcome Scale (GOS) of 5. The Glasgow Outcome Scale (GOS) will be determined patients charts review and/or general practitioner interview conducted by an independent assessor. The GOS score : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]
Functional impairment	3 months, and 1-year, 5-years and 10-years	Percentages of the patients that experience functional impairment (motor, sensitive, cognitive, epilepsy)
total seizure duration	72 hours	total seizure duration in minutes
percentages of the patients that experience recurrent convulsive and/or non-convulsive seizures within 12 hours after ICU admission	12 hours

Trial Locations

Locations (20)

CHU Beaujon; 🇫🇷 Clichy, France

CH Public du Cotentin - Service de Réanimation - Médecin intensive; 🇫🇷 Cherbourg, France

Centre Hospitalier Universitaire de Nantes; 🇫🇷 Nantes, France

Hôpital privé Jacques Cartier - Service de réanimation médico chirurgicale; 🇫🇷 Massy, France

CH de Bethune - Service de Réanimation et Surveillance continue; 🇫🇷 Beuvry, France

CH de Beauvais - Service de réanimation polyvalente; 🇫🇷 Beauvais, France

CH Angouleme - Service de réanimation polyvalente; 🇫🇷 Angoulême, France

Centre Hospitalier Universitaire Régional; 🇫🇷 Brest, France

Intensive Care Unit - Versailles Hospital; 🇫🇷 Le Chesnay, France

HP Claude Galien - Service de Réanimation Polyvalente; 🇫🇷 Quincy-sous-Sénart, France

CH Brive La Gaillarde - Service de réanimation - USC; 🇫🇷 Brive-la-Gaillarde, France

Centre Hospitalier Universitaire de Dijon; 🇫🇷 Dijon, France

CH de La Rochelle - Service de réanimation - USC; 🇫🇷 La Rochelle, France

CH de Cannes; 🇫🇷 Cannes, France

Hopitaux Universitaires Henri Mondor - Service d'anesthésie et des réanimations chirurgicales, Unité d'anesthésie-réanimation chirurgical cardiovasculaire; 🇫🇷 Créteil, France

Centre Hospitalier de Dieppe; 🇫🇷 Dieppe, France

Groupe Hospitalier Sud Ile de France - Service de Réanimation - Médecin intensive; 🇫🇷 Melun, France

Centre hospitalier de Roanne - Service de Réanimation - Soins continus; 🇫🇷 Roanne, France

Centre Hospitalier de Toulon; 🇫🇷 Toulon, France

Groupe Hospitalier Paris Saint Joseph - Service de réanimation médico chirurgicale; 🇫🇷 Paris, France