NCT03457831

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
32mo left

Started Feb 2018

Longer than P75 for all trials

Geographic Reach
1 country

20 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress76%
Feb 2018Dec 2028

First Submitted

Initial submission to the registry

February 28, 2018

Completed
Same day until next milestone

Study Start

First participant enrolled

February 28, 2018

Completed
8 days until next milestone

First Posted

Study publicly available on registry

March 8, 2018

Completed
10.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2028

Last Updated

October 22, 2020

Status Verified

October 1, 2020

Enrollment Period

10.8 years

First QC Date

February 28, 2018

Last Update Submit

October 20, 2020

Conditions

Status Epilepticus

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (8)

  • Favorable outcome

    3 months, 5-years and 10 years

  • Functional impairment

    3 months, and 1-year, 5-years and 10-years

  • total seizure duration

    72 hours

  • 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

  • +3 more secondary outcomes

Study Arms (1)

Status Epilepticus

Convulsive and Non-Convulsive Status Epilepticus ; and Pseudo Status Epilepticus

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

critically ill patients requiring ICU hospitalisation

You may qualify if:

  • 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

You may not qualify if:

  • age \< 18 years
  • postanoxic status epilepticus

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (20)

CH Angouleme - Service de réanimation polyvalente

Angoulême, 16959, France

RECRUITING

CH de Beauvais - Service de réanimation polyvalente

Beauvais, 60000, France

RECRUITING

CH de Bethune - Service de Réanimation et Surveillance continue

Beuvry, 62660, France

RECRUITING

Centre Hospitalier Universitaire Régional

Brest, 29200, France

RECRUITING

CH Brive La Gaillarde - Service de réanimation - USC

Brive-la-Gaillarde, 19100, France

RECRUITING

CH de Cannes

Cannes, France

RECRUITING

CH Public du Cotentin - Service de Réanimation - Médecin intensive

Cherbourg, 50102, France

RECRUITING

CHU Beaujon

Clichy, France

RECRUITING

Hopitaux Universitaires Henri Mondor - Service d'anesthésie et des réanimations chirurgicales, Unité d'anesthésie-réanimation chirurgical cardiovasculaire

Créteil, 94010, France

RECRUITING

Centre Hospitalier de Dieppe

Dieppe, 76202, France

RECRUITING

Centre Hospitalier Universitaire de Dijon

Dijon, 21079, France

RECRUITING

CH de La Rochelle - Service de réanimation - USC

La Rochelle, 17019, France

RECRUITING

Intensive Care Unit - Versailles Hospital

Le Chesnay, 78150, France

RECRUITING

Hôpital privé Jacques Cartier - Service de réanimation médico chirurgicale

Massy, 91300, France

RECRUITING

Groupe Hospitalier Sud Ile de France - Service de Réanimation - Médecin intensive

Melun, 77011, France

RECRUITING

Centre Hospitalier Universitaire de Nantes

Nantes, 44093, France

RECRUITING

Groupe Hospitalier Paris Saint Joseph - Service de réanimation médico chirurgicale

Paris, 75014, France

RECRUITING

HP Claude Galien - Service de Réanimation Polyvalente

Quincy-sous-Sénart, 91480, France

RECRUITING

Centre hospitalier de Roanne - Service de Réanimation - Soins continus

Roanne, 42328, France

RECRUITING

Centre Hospitalier de Toulon

Toulon, 83100, France

RECRUITING

Related Publications (3)

  • Vieille T, Jacq G, Merceron S, Huriaux L, Chelly J, Quenot JP, Legriel S. Management and outcomes of critically ill adult patients with convulsive status epilepticus and preadmission functional impairments. Epilepsy Behav. 2023 Apr;141:109083. doi: 10.1016/j.yebeh.2023.109083. Epub 2023 Feb 18.

    PMID: 36803873DERIVED

  • Chinardet P, Gilles F, Cochet H, Chelly J, Quenot JP, Jacq G, Soulier P, Lesieur O, Beuret P, Holleville M, Bruel C, Bailly P, Sauneuf B, Sejourne C, Galbois A, Fontaine C, Perier F, Pichon N, Arrayago M, Mongardon N, Schnell D, Lascarrou JB, Convers R, Legriel S. Electrocardiographic Changes at the Early Stage of Status Epilepticus: First Insights From the ICTAL Registry. Crit Care Med. 2023 Mar 1;51(3):388-400. doi: 10.1097/CCM.0000000000005768. Epub 2022 Dec 19.

    PMID: 36533915DERIVED

  • 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.

    PMID: 35168989DERIVED

MeSH Terms

Conditions

Status Epilepticus

Condition Hierarchy (Ancestors)

SeizuresNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • stephane LEGRIEL, MD

    Ictal Group

    PRINCIPAL INVESTIGATOR

Central Study Contacts

stephane LEGRIEL, MD

CONTACT

+33139639717slegriel@ch-versailles.fr

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Target Duration
10 Years
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 28, 2018

First Posted

March 8, 2018

Study Start

February 28, 2018

Primary Completion (Estimated)

December 31, 2028

Study Completion (Estimated)

December 31, 2028

Last Updated

October 22, 2020

Record last verified: 2020-10

Locations

FR(20)