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Status Epilepticus in the Critically Ill Patients

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ClinicalTrials.gov Identifier: NCT03457831
Recruitment Status : Recruiting
First Posted : March 8, 2018
Last Update Posted : October 22, 2020
Sponsor:
Collaborator:
Versailles Hospital
Information provided by (Responsible Party):
Ictal Group

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.


Condition or disease
Status Epilepticus

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: Status Epilepticus in the Critically Ill Patients
Actual Study Start Date : February 28, 2018
Estimated Primary Completion Date : December 31, 2028
Estimated Study Completion Date : December 31, 2028

Resource links provided by the National Library of Medicine


Group/Cohort
Status Epilepticus
Convulsive and Non-Convulsive Status Epilepticus ; and Pseudo Status Epilepticus



Primary Outcome Measures :
  1. Favorable outcome [ Time Frame: 1 year ]
    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]


Secondary Outcome Measures :
  1. Favorable outcome [ Time Frame: 3 months, 5-years and 10 years ]
    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]

  2. Functional impairment [ Time Frame: 3 months, and 1-year, 5-years and 10-years ]
    Percentages of the patients that experience functional impairment (motor, sensitive, cognitive, epilepsy)

  3. total seizure duration [ Time Frame: 72 hours ]
    total seizure duration in minutes

  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 [ Time Frame: 90 days ]
    total ICU and in-hospital length of stay in days

  8. mortality rate [ Time Frame: ICU and hospital discharge, 3-months, and 1-year, 5 years and 10 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
critically ill patients requiring ICU hospitalisation
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03457831


Contacts
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Contact: stephane LEGRIEL, MD +33139639717 slegriel@ch-versailles.fr

Locations
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Sponsors and Collaborators
Ictal Group
Versailles Hospital
Investigators
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Principal Investigator: stephane LEGRIEL, MD Ictal Group
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Ictal Group
ClinicalTrials.gov Identifier: NCT03457831    
Other Study ID Numbers: ICTAL SE REGISTRY
First Posted: March 8, 2018    Key Record Dates
Last Update Posted: October 22, 2020
Last Verified: October 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Status Epilepticus
Seizures
Neurologic Manifestations
Nervous System Diseases