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NCT Number: NCT03457831

Status Epilepticus in the Critically Ill Patients

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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Key information

Conditions

Status Epilepticus Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Seizures Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Angouleme - Service de réanimation polyvalente, Angoulême, France

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  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 outcomes

  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

Study contacts

Contact information is provided by the study sponsor or research team.

stephane LEGRIEL, MD

CONTACT

[email protected]

+33139639717

Sponsors and collaborators

Lead sponsor

Ictal Group

Other

Collaborators

  • Versailles Hospital

Registry information

Important dates

Study start
2018
Primary completion
2028
Study completion
2028
First posted
Mar 8, 2018
Registry last updated
Oct 22, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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