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Status EpilepticusNCT03457831

Status Epilepticus in the Critically Ill Patients

An observational study of Status Epilepticus, run by Ictal Group at 20 sites in France.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Status Epilepticus
How many people
1,000 participants
Where
20 sitesFrance
Study dates
28 Feb 2018to 31 Dec 2028
How long will I take part?
10 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Study population: critically ill patients requiring ICU hospitalisation

Who may be able to join

  • 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

Who cannot join

  • age < 18 years
  • postanoxic status epilepticus

Trial locations and contacts

20 sites in 1 country. Contact the study team or a site near you to ask about taking part.

stephane LEGRIEL, MD contact

+33139639717

slegriel@ch-versailles.fr

20 sites in 1 country

France20 sites, 20 recruiting

  • CH Angouleme - Service de réanimation polyvalente

    Angoulême, 16959

    David SCHNELL, MD, +33 5 45 24 41 57, david.schnell@ch-angouleme.fr

    David SCHNELL, MD

    Recruiting

  • CH de Beauvais - Service de réanimation polyvalente

    Beauvais, 60000

    Jack RICHECOEUR, MD, + 33 3 44 11 21 87, jack.richecoeur@gmail.com

    Jack RICHECOEUR, MD

    Recruiting

  • CH de Bethune - Service de Réanimation et Surveillance continue

    Beuvry, 62660

    Caroline SEJOURNE, MD, +33 0321 644 482, csejourne@ch-bethune.fr

    Christophe VINSONNEAU, +33 0321 644 482, cvinsonneau@ch-bethune.fr

    Recruiting

  • Centre Hospitalier Universitaire Régional

    Brest, 29200

    Pierre BAILLY, MD, pierre.bailly@chu-brest.fr

    Recruiting

  • CH Brive La Gaillarde - Service de réanimation - USC

    Brive-la-Gaillarde, 19100

    Nicolas PICHON, MD, +33 5 55 92 60 13, nicolas.pichon@ch-brive.fr

    Nicolas PICHON, MD

    Recruiting

  • CH de Cannes

    Cannes

    Marine ARRAYAGO, MD

    Recruiting

  • CH Public du Cotentin - Service de Réanimation - Médecin intensive

    Cherbourg, 50102

    Bertrand SAUNEUF, MD, + 33 2 33 20 76 80, b.sauneuf@ch-cotentin.fr

    Bertrand SAUNEUF, MD

    Recruiting

  • CHU Beaujon

    Clichy

    Mathilde HOLLEVILLE, MD

    Mathilde HOLLEVILLE, MD

    Recruiting

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

    Créteil, 94010

    Nicolas MONGARDON, MD, PhD, + 33 1 49 81 21 11, nicolas.mongardon@aphp.fr

    Nicolas MONGARDON, MD, PhD

    Recruiting

  • Centre Hospitalier de Dieppe

    Dieppe, 76202

    Jean-Philippe RIGAUD, MD, PhD, + 33 2 32 14 75 49, JRigaud@ch-dieppe.fr

    Jean-Philippe RIGAUD, MD, PhD

    Recruiting

  • Centre Hospitalier Universitaire de Dijon

    Dijon, 21079

    Audrey MASSARD, +33 3 80 28 13 03, audrey.massard@chu-dijon.fr

    Solenne VILLOT, +33 3 80 28 13 03, solenne.villot@chu-dijon.fr

    Recruiting

  • CH de La Rochelle - Service de réanimation - USC

    La Rochelle, 17019

    Olivier LESIEUR, MD, PhD, + 33 5 46 45 66 54, olivier.lesieur@ch-larochelle.fr

    Olivier LESIEUR, MD, PhD

    Recruiting

  • Intensive Care Unit - Versailles Hospital

    Le Chesnay, 78150

    stephane LEGRIEL, MD, slegriel@ch-versailles.fr

    Stephane LEGRIEL, MD

    Recruiting

  • Hôpital privé Jacques Cartier - Service de réanimation médico chirurgicale

    Massy, 91300

    Wulfran BOUGOUIN, MD, PhD, + 33 1 60 13 60 60, wulfran.bougouin@gmail.com

    Wulfran BOUGOUIN, MD, PhD

    Recruiting

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

    Melun, 77011

    Jonathan CHELLY, MD, + 33 1 64 71 66 21, jonathan.chelly@ch-melun.fr

    Nathalie ROLLIN, MD, nathalie.rolin@ch-melun.fr

    Recruiting

  • Centre Hospitalier Universitaire de Nantes

    Nantes, 44093

    Jean-Baptiste LASCARROU, MD, 02 53 48 24 73, jeanbaptiste.lascarrou@chu-nantes.fr

    Diane MAUGARS, Diane.MAUGARS@chu-nantes.fr

    Recruiting

  • Groupe Hospitalier Paris Saint Joseph - Service de réanimation médico chirurgicale

    Paris, 75014

    Cedric BRUEL, MD, + 33 1 44 12 30 85, cbruel@hpsj.fr

    Cedric BRUEL, MD

    Recruiting

  • HP Claude Galien - Service de Réanimation Polyvalente

    Quincy-sous-Sénart, 91480

    Arnaud GALBOIS, MD, PhD, +33 1 69 39 90 00, galbois@gmail.com

    Arnaud GALBOIS, MD, PhD

    Recruiting

  • Centre hospitalier de Roanne - Service de Réanimation - Soins continus

    Roanne, 42328

    Pascal BEURET, MD, +33 4 77 44 31 07, pascal.beuret@ch-roanne.fr

    Pascal BEURET, MD

    Recruiting

  • Centre Hospitalier de Toulon

    Toulon, 83100

    Jonathan CHELLY, MD, 04 94 14 50 00, JONATHAN.CHELLY@ch-toulon.fr

    Recruiting

Other trials in France

About this study

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.

Medical subject headings
Status Epilepticus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT03457831
Study groupRoleWhat they receive
Status EpilepticusConvulsive and Non-Convulsive Status Epilepticus ; and Pseudo Status Epilepticus

What is being measured

The primary outcome is the main question the study is designed to answer.

  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]

    Measured: 1 year

Secondary outcomes (8)

  1. 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]

    Measured: 3 months, 5-years and 10 years

  2. Functional impairment

    Percentages of the patients that experience functional impairment (motor, sensitive, cognitive, epilepsy)

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

  3. total seizure duration

    total seizure duration in minutes

    Measured: 72 hours

  4. percentages of the patients that experience recurrent convulsive and/or non-convulsive seizures within 12 hours after ICU admission

    Measured: 12 hours

  5. refractory status epilepticus

    Measured: 24 hours

  6. super refractory status epilepticus

    Measured: 72 hours

  7. total ICU and in-hospital length of stay

    total ICU and in-hospital length of stay in days

    Measured: 90 days

  8. mortality rate

    Measured: ICU and hospital discharge, 3-months, and 1-year, 5 years and 10 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Mar 2018
  2. Study start28 Feb 2018
  3. Primary completion31 Dec 2028 (estimated)
  4. Study completion31 Dec 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
1,000 participants (estimated)
Target duration
10 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT03457831
Sponsor's protocol ID
ICTAL SE REGISTRY
Status last verified
Oct 2020
First submitted
28 Feb 2018
Last updated
22 Oct 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Repplinger S, Chelly J, Lesieur O, Quenot JP, Lascarrou JB, Bernard C, Monchi M, Beuret P, Sigaud F, Sboui G, Bailly P, Chambon R, Fontaine C, Mongardon N, Cerf C, Bruel C, Pichon N, Argaud L, Desmeulles I, Kifouche F, Hassani ML, Boubekri A, Vieille T, Marzouk M, Ravaux H, Schnell D, Fourati H, Jacq G, Legriel S. Diagnostic Yield and Therapeutic Impact of Etiologic Investigations After Status Epilepticus: Insights From the ICTAL Registry. Neurology. 2026 Oct 13;107(7):e218544. doi: 10.1212/WNL.0000000000218544. Epub 2026 Sep 21.

    PubMed 42766827

  • Bouquot M, Chelly J, Quenot JP, Lascarrou JB, Bernard C, Monchi M, Beuret P, Sigaud F, Sboui G, Bailly P, Chambon R, Fontaine C, Mongardon N, Cerf C, Bruel C, Pichon N, Argaud L, Kinane M, Desmeulles I, Kifouche F, Hassani ML, Boubekri A, Vieille T, Marzouk M, Ravaux H, Schnell D, Sedillot N, Brunel M, Jacq G, Lesieur O, Legriel S. Potentially Surgical Digestive Complications in Patients With Status Epilepticus: Insights From the ICTAL Registry. Crit Care Med. 2026 Aug 1;54(8):1965-1978. doi: 10.1097/CCM.0000000000007176. Epub 2026 May 28.

    PubMed 42206939

  • 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.

    PubMed 36803873

  • 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.

    PubMed 36533915

  • 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.

    PubMed 35168989

Questions about this trial

What is this clinical trial studying?

An observational study of Status Epilepticus, run by Ictal Group at 20 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 22 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact stephane LEGRIEL, MD (+33139639717, slegriel@ch-versailles.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Favorable outcome (time frame: 1 year). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03457831, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2020.

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