Status Epilepticus in the Critically Ill Patients

October 20, 2020 updated by: Ictal Group

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Angoulême, France, 16959
        • Recruiting
        • CH Angouleme - Service de réanimation polyvalente
        • Contact:
        • Principal Investigator:
          • David SCHNELL, MD
      • Beauvais, France, 60000
        • Recruiting
        • CH de Beauvais - Service de réanimation polyvalente
        • Contact:
        • Principal Investigator:
          • Jack RICHECOEUR, MD
      • Beuvry, France, 62660
        • Recruiting
        • CH de Bethune - Service de Réanimation et Surveillance continue
        • Contact:
        • Contact:
      • Brest, France, 29200
        • Recruiting
        • Centre Hospitalier Universitaire Régional
      • Brive-la-Gaillarde, France, 19100
        • Recruiting
        • CH Brive La Gaillarde - Service de réanimation - USC
        • Contact:
        • Principal Investigator:
          • Nicolas PICHON, MD
      • Cannes, France
        • Recruiting
        • CH de Cannes
        • Contact:
          • Marine ARRAYAGO, MD
      • Cherbourg, France, 50102
        • Recruiting
        • CH Public du Cotentin - Service de Réanimation - Médecin intensive
        • Contact:
        • Principal Investigator:
          • Bertrand SAUNEUF, MD
      • Clichy, France
        • Recruiting
        • CHU Beaujon
        • Contact:
          • Mathilde HOLLEVILLE, MD
        • Principal Investigator:
          • Mathilde HOLLEVILLE, MD
      • Créteil, France, 94010
        • Recruiting
        • Hopitaux Universitaires Henri Mondor - Service d'anesthésie et des réanimations chirurgicales, Unité d'anesthésie-réanimation chirurgical cardiovasculaire
        • Contact:
        • Principal Investigator:
          • Nicolas MONGARDON, MD, PhD
      • Dieppe, France, 76202
        • Recruiting
        • Centre Hospitalier de Dieppe
        • Contact:
        • Principal Investigator:
          • Jean-Philippe RIGAUD, MD, PhD
      • Dijon, France, 21079
        • Recruiting
        • Centre Hospitalier Universitaire de Dijon
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jean-Pierre QUENOT, MD, PhD
      • La Rochelle, France, 17019
        • Recruiting
        • CH de La Rochelle - Service de réanimation - USC
        • Contact:
        • Principal Investigator:
          • Olivier LESIEUR, MD, PhD
      • Le Chesnay, France, 78150
        • Recruiting
        • Intensive Care Unit - Versailles Hospital
        • Contact:
        • Principal Investigator:
          • Stephane LEGRIEL, MD
        • Sub-Investigator:
          • Gwenaëlle JACQ, RN
      • Massy, France, 91300
        • Recruiting
        • Hôpital privé Jacques Cartier - Service de réanimation médico chirurgicale
        • Contact:
        • Principal Investigator:
          • Wulfran BOUGOUIN, MD, PhD
      • Melun, France, 77011
        • Recruiting
        • Groupe Hospitalier Sud Ile de France - Service de Réanimation - Médecin intensive
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jonathan CHELLY, MD
        • Sub-Investigator:
          • Nathalie ROLLIN, MD
      • Nantes, France, 44093
      • Paris, France, 75014
        • Recruiting
        • Groupe Hospitalier Paris Saint Joseph - Service de réanimation médico chirurgicale
        • Contact:
          • Cedric BRUEL, MD
          • Phone Number: + 33 1 44 12 30 85
          • Email: cbruel@hpsj.fr
      • Quincy-sous-Sénart, France, 91480
        • Recruiting
        • HP Claude Galien - Service de Réanimation Polyvalente
        • Contact:
        • Principal Investigator:
          • Arnaud GALBOIS, MD, PhD
      • Roanne, France, 42328
        • Recruiting
        • Centre hospitalier de Roanne - Service de Réanimation - Soins continus
        • Principal Investigator:
          • Pascal BEURET, MD
        • Contact:
      • Toulon, France, 83100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

critically ill patients requiring ICU hospitalisation

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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]
3 months, 5-years and 10 years
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 months, and 1-year, 5-years and 10-years
total seizure duration
Time Frame: 72 hours
total seizure duration in minutes
72 hours
percentages of the patients that experience recurrent convulsive and/or non-convulsive seizures within 12 hours after ICU admission
Time Frame: 12 hours
12 hours
refractory status epilepticus
Time Frame: 24 hours
24 hours
super refractory status epilepticus
Time Frame: 72 hours
72 hours
total ICU and in-hospital length of stay
Time Frame: 90 days
total ICU and in-hospital length of stay in days
90 days
mortality rate
Time Frame: ICU and hospital discharge, 3-months, and 1-year, 5 years and 10 years
ICU and hospital discharge, 3-months, and 1-year, 5 years and 10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ictal Group

Collaborators

Versailles Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 28, 2018

Primary Completion (ANTICIPATED)

December 31, 2028

Study Completion (ANTICIPATED)

December 31, 2028

Study Registration Dates

First Submitted

February 28, 2018

First Submitted That Met QC Criteria

March 6, 2018

First Posted (ACTUAL)

March 8, 2018

Study Record Updates

Last Update Posted (ACTUAL)

October 22, 2020

Last Update Submitted That Met QC Criteria

October 20, 2020

Last Verified

October 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICTAL SE REGISTRY

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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