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Status Epilepticus in the Critically Ill Patients

Status Epilepticus in the Critically Ill Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03457831
Enrollment
1000
Registered
2018-03-08
Start date
2018-02-28
Completion date
2028-12-31
Last updated
2020-10-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Status Epilepticus

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.

Interventions

None listed

Sponsors

Versailles Hospital
CollaboratorOTHER
Ictal Group
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Favorable outcome1 yearA 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 : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]

Secondary

MeasureTime frameDescription
Functional impairment3 months, and 1-year, 5-years and 10-yearsPercentages of the patients that experience functional impairment (motor, sensitive, cognitive, epilepsy)
total seizure duration72 hourstotal seizure duration in minutes
percentages of the patients that experience recurrent convulsive and/or non-convulsive seizures within 12 hours after ICU admission12 hours
Favorable outcome3 months, 5-years and 10 yearsA 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 : \[1: Death, 2: Persistent vegetative state, 3: Severe disability, 4: Moderate disability, 5 : Low disability\]
super refractory status epilepticus72 hours
total ICU and in-hospital length of stay90 daystotal ICU and in-hospital length of stay in days
mortality rateICU and hospital discharge, 3-months, and 1-year, 5 years and 10 years
refractory status epilepticus24 hours

Countries

France

Contacts

Primary Contactstephane LEGRIEL, MD
slegriel@ch-versailles.fr+33139639717

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 13, 2026