Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE) (SENSEII/AROUSE)
Study Overview
Status
Conditions
Detailed Description
SENSE-II/AROUSE is a prospective, multicenter, non-randomized, observational registry study of consecutive cases of SE. We aimed to include university hospitals as well as non-university hospitals to enhance generalizability of the findings.
Currently, 13 high-volume medical centers in Belgium, Austria, Germany, United Kingdom, Switzerland, No common management protocol will be imposed on the participating centers. However, most institutions have established a local protocol that is closely related to the most recent guidelines for the management of SE published by the American Epilepsy Society (AES) in 2016.
We will exclude patients with anoxic status epilepticus after cardiac arrest and patients younger than 18 years.
Clinical and EEG Data will be collected prospectively from the admission of the patient to the discharge. Data collection will be performed using Research Electronic Data Capture (REDCap) electronic data capture tools hosted at Erasme Hospital in Brussels, Belgium.
To reach sufficient statistical power for multivariate analysis, a cohort size of 3000 patients is targeted.
The main objective of the study is to document patient characteristics, treatment modalities, EEG features and outcome of adults treated for SE and identify predictors of outcome. The data collected in this study could also identify gaps and opportunities for the management of this medical emergency. Lacking adequate prospective controlled trials, this will help both decision-making in clinical practice and designing future clinical trials.
Moreover, EEG data will help for a better electroencephalographic definition of SE, possible SE, and some boundary conditions, such as ictal-interictal continuum.
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Nicolas Gaspard, MD, PhD
- Phone Number: 00325553429
- Email: Nicolas.Gaspard@erasme.ulb.ac.be
Study Contact Backup
- Name: Charlotte Damien, MD
- Phone Number: 00325553429
- Email: Charlotte.Damien@erasme.ulb.ac.be
Study Locations
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Linz, Austria
- Not yet recruiting
- Kepler University Linz
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Contact:
- Raimund Helbok, MD, PhD
- Email: raimund.helbok@tirol-kliniken.at
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Principal Investigator:
- Raimund Helbok, MD, PhD
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Salzburg, Austria
- Not yet recruiting
- Christian Doppler Klinik of Paracelsus Medical University
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Contact:
- Markus Leitinger, MD, PhD
- Email: ma.leitinger@salk.at
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Contact:
- Eugen Trinka, MD, PhD
- Email: eugen@trinka.at
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Principal Investigator:
- Markus Leitinger, MD, PhD
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Principal Investigator:
- Eugen Trinka, MD, PhD
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Brussel, Belgium, 1070
- Recruiting
- HUB Erasme
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Contact:
- Nicolas Gaspard, MD, PhD
- Phone Number: 00325553429
- Email: Nicolas.Gaspard@hubruxelles.be
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Contact:
- Charlotte Damien, MD
- Phone Number: 00325553429
- Email: Charlotte.Damien@hubruxelles.be
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Principal Investigator:
- Charlotte Damien, MD
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Principal Investigator:
- Nicolas Gaspard, MD, PhD
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Odense, Denmark
- Recruiting
- Odense University Hospital & Svenborg Hospital
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Contact:
- Christoph Beier, MD
- Email: Christoph.Beier@rsyd.dk
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Principal Investigator:
- Christop Beier, MD
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Helsinki, Finland
- Not yet recruiting
- Helsinki University Central Hospital
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Principal Investigator:
- Daniel Strbian, MD
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Contact:
- Daniel Strbian, MD
- Email: Daniel.strbian@hus.fi
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Contact:
- Leena Kampii, MD
- Email: Leena.kamppi@hus.fi
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Sub-Investigator:
- Leena Kampii, MD
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Sub-Investigator:
- Nina Forss, MS
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Frankfurt, Germany
- Not yet recruiting
- Goethe-Universität Frankfurt am Main
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Contact:
- Adam Strzelczyk, MD
- Email: strzelczyk@med.uni-frankfurt.de
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Contact:
- Felix Rosenow, MD
- Email: Felix.Rosenow@kgu.de
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Principal Investigator:
- Adam Strzelczyk, MD
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Sub-Investigator:
- Felix Rosenow, MD
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Osnabrück, Germany, D-49078
- Not yet recruiting
- Epilepsy Center Münster-Osnabrück, Klinikum Osnabrück
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Contact:
- Christoph Kellinghaus, MD
- Email: Christoph.Kellinghaus@klinikum-os.de
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Principal Investigator:
- Christoph Kellinghaus, MD
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Oslo, Norway
- Not yet recruiting
- Oslo University Hospital
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Contact:
- Erik Taubøll, MD
- Email: erik.tauboll@medisin.uio.no
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Principal Investigator:
- Erik Taubøll, MD
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Basel, Switzerland
- Not yet recruiting
- University Hospital Basel
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Contact:
- Stephan Rueegg, MD
- Email: stephan.rueegg@usb.ch
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Contact:
- Raoul Sutter, MD
- Email: raoul.sutter@usb.ch
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Principal Investigator:
- Stephan Rueegg, MD
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Principal Investigator:
- Raoul Sutter, MD
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Geneva, Switzerland
- Not yet recruiting
- University Hospital of Geneva
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Contact:
- Pia De Stefano, MD
- Email: Pia.deStefano@hcuge.ch
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Principal Investigator:
- Pia De Stefano, MD
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Birmingham, United Kingdom
- Not yet recruiting
- Birmingham University Hospitals NHS Trust
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Contact:
- Maxwell Damian, MD
- Email: msdd2@cam.ac.uk
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Principal Investigator:
- Maxwell Damian, MD
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 18 years or above
- Patients admitted for management of Status Epilepticus as their primary diagnosis
- Patients admitted for another primary diagnosis but identified with Status Epilepticus during their acute hospital stay
Exclusion Criteria:
- Patients with post-cardiac arrest SE
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Modified Rankin Scale
Time Frame: On the date of discharge from hospital or date of death from any cause, assessed up to 24 months
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Functional outcome will be assessed by the modified Rankin scale (mRS).
mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).
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On the date of discharge from hospital or date of death from any cause, assessed up to 24 months
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Refractoriness
Time Frame: From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months
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Refractory Status Epilepticus is defined as Status Epilepticus persisting despite administration of at least two appropriately selected and dosed parenteral medications including a benzodiazepine.
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From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Modified Rankin Scale
Time Frame: At 30 days after the date of inclusion or SE onset (if still hospitalized)
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Functional outcome will be assessed by the modified Rankin scale (mRS).
mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).
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At 30 days after the date of inclusion or SE onset (if still hospitalized)
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Modified Rankin Scale
Time Frame: At 3 months after the date of discharge from hospital
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Functional outcome will be assessed by the modified Rankin scale (mRS).
mRS is as scale from 0 to 6 : 0 being a patient without symptoms (better outcome) and 6 being a deceased patient (worse outcome).
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At 3 months after the date of discharge from hospital
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Super-refractoriness
Time Frame: From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months
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Super-refractory status epilepticus is defined as Status Epilepticus persisting or recurring after 24 hours or more of treatment with continuous intravenous anesthetic drugs or when therapy is tapered after 24 hours of use.
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From date of study inclusion until the date of discharge from hospital or date of death from any cause, assessed up to 24 months
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicolas Gaspard, MD, PhD, Erasme UH
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- P2020/483/B4062020000170
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
Data will be deidentified and collected through RedCap by each local investigator.
IPD will be accessible and shared only with the researchers involved in this registry.
These de-identified data will be available for the duration of the registry and on reasonable request to Nicolas Gaspard after publication of the results.
IPD Sharing Access Criteria
IPD Sharing Supporting Information Type
- STUDY_PROTOCOL
- SAP
- ICF
- CSR
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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