Status Epilepticus in the Critically Ill Patients

NCT ID: NCT03457831

Last Updated: 2020-10-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

1000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-02-28

Study Completion Date

2028-12-31

Brief Summary

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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

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Conditions

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Status Epilepticus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Status Epilepticus

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Versailles Hospital

OTHER

Sponsor Role collaborator

Ictal Group

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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stephane LEGRIEL, MD

Role: PRINCIPAL_INVESTIGATOR

Ictal Group

Locations

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CH Angouleme - Service de réanimation polyvalente

Angoulême, , France

Site Status RECRUITING

CH de Beauvais - Service de réanimation polyvalente

Beauvais, , France

Site Status RECRUITING

CH de Bethune - Service de Réanimation et Surveillance continue

Beuvry, , France

Site Status RECRUITING

Centre Hospitalier Universitaire Régional

Brest, , France

Site Status RECRUITING

CH Brive La Gaillarde - Service de réanimation - USC

Brive-la-Gaillarde, , France

Site Status RECRUITING

CH de Cannes

Cannes, , France

Site Status RECRUITING

CH Public du Cotentin - Service de Réanimation - Médecin intensive

Cherbourg, , France

Site Status RECRUITING

CHU Beaujon

Clichy, , France

Site Status RECRUITING

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

Créteil, , France

Site Status RECRUITING

Centre Hospitalier de Dieppe

Dieppe, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Dijon

Dijon, , France

Site Status RECRUITING

CH de La Rochelle - Service de réanimation - USC

La Rochelle, , France

Site Status RECRUITING

Intensive Care Unit - Versailles Hospital

Le Chesnay, , France

Site Status RECRUITING

Hôpital privé Jacques Cartier - Service de réanimation médico chirurgicale

Massy, , France

Site Status RECRUITING

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

Melun, , France

Site Status RECRUITING

Centre Hospitalier Universitaire de Nantes

Nantes, , France

Site Status RECRUITING

Groupe Hospitalier Paris Saint Joseph - Service de réanimation médico chirurgicale

Paris, , France

Site Status RECRUITING

HP Claude Galien - Service de Réanimation Polyvalente

Quincy-sous-Sénart, , France

Site Status RECRUITING

Centre hospitalier de Roanne - Service de Réanimation - Soins continus

Roanne, , France

Site Status RECRUITING

Centre Hospitalier de Toulon

Toulon, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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stephane LEGRIEL, MD

Role: CONTACT

+33139639717

Facility Contacts

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David SCHNELL, MD

Role: primary

+33 5 45 24 41 57

Jack RICHECOEUR, MD

Role: primary

+ 33 3 44 11 21 87

Caroline SEJOURNE, MD

Role: primary

+33 0321 644 482

Christophe VINSONNEAU

Role: backup

+33 0321 644 482

Pierre BAILLY, MD

Role: primary

Nicolas PICHON, MD

Role: primary

+33 5 55 92 60 13

Marine ARRAYAGO, MD

Role: primary

Bertrand SAUNEUF, MD

Role: primary

+ 33 2 33 20 76 80

Mathilde HOLLEVILLE, MD

Role: primary

Nicolas MONGARDON, MD, PhD

Role: primary

+ 33 1 49 81 21 11

Jean-Philippe RIGAUD, MD, PhD

Role: primary

+ 33 2 32 14 75 49

Audrey MASSARD

Role: primary

+33 3 80 28 13 03

Solenne VILLOT

Role: backup

+33 3 80 28 13 03

Olivier LESIEUR, MD, PhD

Role: primary

+ 33 5 46 45 66 54

stephane LEGRIEL, MD

Role: primary

Wulfran BOUGOUIN, MD, PhD

Role: primary

+ 33 1 60 13 60 60

Jonathan CHELLY, MD

Role: primary

+ 33 1 64 71 66 21

Nathalie ROLLIN, MD

Role: backup

Jean-Baptiste LASCARROU, MD

Role: primary

02 53 48 24 73

Diane MAUGARS

Role: backup

Cedric BRUEL, MD

Role: primary

+ 33 1 44 12 30 85

Arnaud GALBOIS, MD, PhD

Role: primary

+33 1 69 39 90 00

Pascal BEURET, MD

Role: primary

+33 4 77 44 31 07

Jonathan CHELLY, MD

Role: primary

04 94 14 50 00

References

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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.

Reference Type DERIVED
PMID: 36803873 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36533915 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35168989 (View on PubMed)

Other Identifiers

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ICTAL SE REGISTRY

Identifier Type: -

Identifier Source: org_study_id

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