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NCT Number: NCT05839418

Sustained Effort Network for Treatment of Status Epilepticus/European Academy of Neurology Registry on Refractory Status Epilepticus (SENSE-II/AROUSE)

SENSE-II/AROUSE is a prospective, multicenter registry for patients treated for SE. The primary objective is to document patients and SE characteristics, treatment modalities, EEG features, and outcome of consecutive adults admitted fir SE treatment in each of the participating centers and to identify predictors of outcome and refractoriness.

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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

Kepler University Linz, Linz, Austria

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Primary outcomes

  1. Modified Rankin Scale

    Time frame: On the date of discharge from hospital or date of death from any cause, assessed up to 24 months

    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).

  2. 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

    Refractory Status Epilepticus is defined as Status Epilepticus persisting despite administration of at least two appropriately selected and dosed parenteral medications including a benzodiazepine.

Secondary outcomes

  1. Modified Rankin Scale

    Time frame: At 30 days after the date of inclusion or SE onset (if still hospitalized)

    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).

  2. Modified Rankin Scale

    Time frame: At 3 months after the date of discharge from hospital

    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).

  3. 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

    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.

Study contacts

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

Charlotte Damien, MD

CONTACT

[email protected]

00325553429

Nicolas Gaspard, MD, PhD

CONTACT

[email protected]

00325553429

Sponsors and collaborators

Lead sponsor

Erasme University Hospital

Other

Registry information

Acronym: SENSEII/AROUSE

Important dates

Study start
2023
Primary completion
2028
Study completion
2028
First posted
May 3, 2023
Registry last updated
May 3, 2023

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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