Status Epilepticus in the Critically Ill Patients

Status Epilepticus Clinical Trial

Official title:

Status Epilepticus in the Critically Ill Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03457831
• Other study ID #: ICTAL SE REGISTRY
• Status: Recruiting
• Start date: February 28, 2018
• Est. completion date: December 31, 2028

Study information

• Verified date: October 2020
• Source: Ictal Group
• Contact: stephane LEGRIEL, MD
• Phone: +33139639717
• Email: slegriel[@]ch-versailles.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1000
• Est. completion date: December 31, 2028
• Est. primary completion date: December 31, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Status Epilepticus

Locations

Country	Name	City	State
France	CH Angouleme - Service de réanimation polyvalente	Angoulême
France	CH de Beauvais - Service de réanimation polyvalente	Beauvais
France	CH de Bethune - Service de Réanimation et Surveillance continue	Beuvry
France	Centre Hospitalier Universitaire Régional	Brest
France	CH Brive La Gaillarde - Service de réanimation - USC	Brive-la-Gaillarde
France	CH de Cannes	Cannes
France	CH Public du Cotentin - Service de Réanimation - Médecin intensive	Cherbourg
France	CHU Beaujon	Clichy
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	Centre Hospitalier Universitaire de Dijon	Dijon
France	CH de La Rochelle - Service de réanimation - USC	La Rochelle
France	Intensive Care Unit - Versailles Hospital	Le Chesnay
France	Hôpital privé Jacques Cartier - Service de réanimation médico chirurgicale	Massy
France	Groupe Hospitalier Sud Ile de France - Service de Réanimation - Médecin intensive	Melun
France	Centre Hospitalier Universitaire de Nantes	Nantes
France	Groupe Hospitalier Paris Saint Joseph - Service de réanimation médico chirurgicale	Paris
France	HP Claude Galien - Service de Réanimation Polyvalente	Quincy-sous-Sénart
France	Centre hospitalier de Roanne - Service de Réanimation - Soins continus	Roanne
France	Centre Hospitalier de Toulon	Toulon

Sponsors (2)

Lead Sponsor	Collaborator
Ictal Group	Versailles Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Favorable outcome	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]	1 year
Secondary	Favorable outcome	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]	3 months, 5-years and 10 years
Secondary	Functional impairment	Percentages of the patients that experience functional impairment (motor, sensitive, cognitive, epilepsy)	3 months, and 1-year, 5-years and 10-years
Secondary	total seizure duration	total seizure duration in minutes	72 hours
Secondary	percentages of the patients that experience recurrent convulsive and/or non-convulsive seizures within 12 hours after ICU admission		12 hours
Secondary	refractory status epilepticus		24 hours
Secondary	super refractory status epilepticus		72 hours
Secondary	total ICU and in-hospital length of stay	total ICU and in-hospital length of stay in days	90 days
Secondary	mortality rate		ICU and hospital discharge, 3-months, and 1-year, 5 years and 10 years