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RecruitingNCT03457831Updated Oct 22, 2020

Status Epilepticus in the Critically Ill Patients

An observational study in Status Epilepticus, sponsored by Ictal Group. Recruiting at 20 sites in France. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-10-22.

Sponsored by Ictal Group · Observational

From the registry’s dates

  • Started Feb 2018; still recruiting 8 years 8 months later.
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
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Study 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.

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Conditions studied

  • Status Epilepticus

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03

In context

Status Epilepticus

124 studies on the registry are indexed under Status Epilepticus; 37 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 156 across 42 observational studies indexed under Status Epilepticus.

Browse Status Epilepticus studies →

Lead sponsor

Ictal Group is the lead sponsor of 4 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

critically ill patients requiring ICU hospitalisation

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • age \< 18 years
  • postanoxic status epilepticus
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
1,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes

Groups and cohorts

  • Status Epilepticus

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

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What researchers measure

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 : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]

    Time frame: 1 year

Secondary 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 patients charts review and/or general practitioner interview conducted by an independent assessor. The GOS score : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]

    Time frame: 3 months, 5-years and 10 years

  2. Functional impairment

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

    Time frame: 3 months, and 1-year, 5-years and 10-years

  3. total seizure duration

    total seizure duration in minutes

    Time frame: 72 hours

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

    Time frame: 12 hours

  5. refractory status epilepticus

    Time frame: 24 hours

  6. super refractory status epilepticus

    Time frame: 72 hours

  7. total ICU and in-hospital length of stay

    total ICU and in-hospital length of stay in days

    Time frame: 90 days

  8. mortality rate

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

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Study locations

20 of 20 sites recruiting
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References and documents

Publications

  • 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 ↗

Individual participant data

Plan to share: Undecided

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 22, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03457831
Lead sponsor
Ictal Group
Collaborators
Versailles Hospital
Responsible party
Sponsor
First posted
Mar 8, 2018
Start date
Feb 28, 2018
Primary completion
Dec 31, 2028 (estimated)
Completion
Dec 31, 2028 (estimated)
Last update
Oct 22, 2020

Study contacts

stephane LEGRIEL, MD
Contact
slegriel@ch-versailles.fr
+33139639717
stephane LEGRIEL, MD
principal investigator · Ictal Group

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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