Status Epilepticus in the Critically Ill Patients

Sponsor

Ictal Group (Other)

Overall Status

Recruiting

CT.gov ID

NCT03457831

Collaborator

Versailles Hospital (Other)

1,000

Enrollment

Locations

130.1

Anticipated Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Status Epilepticus

Study Design

Study Type:

Observational [Patient Registry]

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Status Epilepticus in the Critically Ill Patients

Actual Study Start Date :

Feb 28, 2018

Anticipated Primary Completion Date :

Dec 31, 2028

Anticipated Study Completion Date :

Dec 31, 2028

Arms and Interventions

Arm	Intervention/Treatment
Status Epilepticus Convulsive and Non-Convulsive Status Epilepticus ; and Pseudo Status Epilepticus

Outcome Measures

Primary Outcome Measures

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

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]
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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	CH Angouleme - Service de réanimation polyvalente	Angoulême	France	16959
2	CH de Beauvais - Service de réanimation polyvalente	Beauvais	France	60000
3	CH de Bethune - Service de Réanimation et Surveillance continue	Beuvry	France	62660
4	Centre Hospitalier Universitaire Régional	Brest	France	29200
5	CH Brive La Gaillarde - Service de réanimation - USC	Brive-la-Gaillarde	France	19100
6	CH de Cannes	Cannes	France
7	CH Public du Cotentin - Service de Réanimation - Médecin intensive	Cherbourg	France	50102
8	CHU Beaujon	Clichy	France
9	Hopitaux Universitaires Henri Mondor - Service d'anesthésie et des réanimations chirurgicales, Unité d'anesthésie-réanimation chirurgical cardiovasculaire	Créteil	France	94010
10	Centre Hospitalier de Dieppe	Dieppe	France	76202
11	Centre Hospitalier Universitaire de Dijon	Dijon	France	21079
12	CH de La Rochelle - Service de réanimation - USC	La Rochelle	France	17019
13	Intensive Care Unit - Versailles Hospital	Le Chesnay	France	78150
14	Hôpital privé Jacques Cartier - Service de réanimation médico chirurgicale	Massy	France	91300
15	Groupe Hospitalier Sud Ile de France - Service de Réanimation - Médecin intensive	Melun	France	77011
16	Centre Hospitalier Universitaire de Nantes	Nantes	France	44093
17	Groupe Hospitalier Paris Saint Joseph - Service de réanimation médico chirurgicale	Paris	France	75014
18	HP Claude Galien - Service de Réanimation Polyvalente	Quincy-sous-Sénart	France	91480
19	Centre hospitalier de Roanne - Service de Réanimation - Soins continus	Roanne	France	42328
20	Centre Hospitalier de Toulon	Toulon	France	83100

Sponsors and Collaborators

Ictal Group
Versailles Hospital

Investigators

Principal Investigator: stephane LEGRIEL, MD, Ictal Group

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Ictal Group

ClinicalTrials.gov Identifier:

NCT03457831

Other Study ID Numbers:

ICTAL SE REGISTRY

First Posted:

Mar 8, 2018

Last Update Posted:

Oct 22, 2020

Last Verified:

Oct 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Status Epilepticus

Study Results

No Results Posted as of Oct 22, 2020