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NCT Number: NCT04204863

Status Epilepticus Population Study (STEPS)

The aim of this observational multicenter cohort study is to gain a deeper understanding regarding the effects of treatment adaption based on information from outcome prediction models, risk stratification, as well as treatment monitoring, detection, prevention, and management of complications on course and outcome of adult patients with status epilepticus (SE).

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Cantonal Hospital Aarau (KSA), Aarau, Switzerland

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Adult patients (i.e., patients ≥18 years of age) with diagnosed SE between 2005 and 2023 who have been treated at the University Hospital of Basel or the Cantonal Hospital Aarau.

Exclusion criteria

  • Patients younger than 18 years.
  • Patients with repetitive epileptic seizures not qualifying for SE.
  • Patients with documented refusal of the general consent.

Treatment and study plan

collection of patient data

Other

Extract data from the digital medical records, the electroencephalographic and microbiologic database.

Primary outcomes

  1. Demographics

    Time frame: between 01.01.2005 and 31.12.2023

    age, sex

  2. Data from acute prehospital management by the emergency medical services (EMS)

    Time frame: between 01.01.2005 and 31.12.2023

    extracted from the treatment protocols of the EMS

  3. Duration of ICU (intensive care unit) and hospital stay, and destination at discharge

    Time frame: between 01.01.2005 and 31.12.2023

    Duration of ICU (intensive care unit) and hospital stay, and destination at discharge

  4. Date(s) of seizure(s) captured by electroencephalographic (EEG) data

    Time frame: between 01.01.2005 and 31.12.2023

    Date(s) of seizure(s) captured by EEG

  5. Seizure history and etiology

    Time frame: between 01.01.2005 and 31.12.2023

    withdrawal from anti seizure drugs, structural, infectious, or autoimmune causes

  6. Number and Duration of SE episodes

    Time frame: between 01.01.2005 and 31.12.2023

    Number and Duration (time) of SE episodes

  7. Types of SE

    Time frame: between 01.01.2005 and 31.12.2023

    Types of SE according to the current guidelines from the International League of Epilepsy (ILAE) (i.e., nonconvulsive with coma, SE with motor symptoms, focal nonconvulsive SE without coma, and subtle SE

  8. Additional features of the seizure

    Time frame: between 01.01.2005 and 31.12.2023

    length, level of consciousness at onset, previous epileptic seizures

  9. ICU Scoring Systems

    Time frame: between 01.01.2005 and 31.12.2023

    Critical illness severity scores (e.g., acute physiology and chronic health Evaluation (APACHE II), simplified acute physiology score (SAPS II), sequential organ failure assessment (SOFA), etc.)

  10. Clinical neurologic monitoring scores

    Time frame: between 01.01.2005 and 31.12.2023

    Clinical neurologic monitoring scores (e.g., Richmond Agitation-Sedation Scale (RASS) , Seda-tion-Agitation Scale (SAS), Glasgow Coma Score (GCS), Intensive Care Delirium Screening Checklist (ICDSC), Status Epilepticus Severity Score (STESS))

  11. Laboratory parameters

    Time frame: between 01.01.2005 and 31.12.2023

    C-Reactive Protein (CRP), albumin, Lactate Dehydrogenase (LDH), Creatin-Kinase (CK), procalcitonin, white blood cell levels, creatinine, liver enzymes, blood gas analyses, metabolic data

  12. Outcome measure

    Time frame: between 01.01.2005 and 31.12.2023

    in-hospital death, survival, survival with neurofunctional alteration, Glasgow Outcome Score, return to neurofunctional premorbid baseline, readmission

  13. Therapeutic features

    Time frame: between 01.01.2005 and 31.12.2023

    duration, dosage and number of treatment medication, number of antiseizure drugs, invasive procedures, such as intubation, mechanical, ventilation, vasopressors, installation of central lines, nutrition

  14. Monitoring of vital signs

    Time frame: between 01.01.2005 and 31.12.2023

    blood pressure, heart rate, respiratory rate, oxygen saturation of the blood, body temperature, level of consciousness

Study contacts

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

Raoul Sutter, PD Dr. med

CONTACT

[email protected]

+41 61 265 25 25

Saskia Semmlack, Dr. med

CONTACT

[email protected]

+41 61 55 65575

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Important dates

Study start
2019
Primary completion
2050
Study completion
2050
First posted
Dec 19, 2019
Registry last updated
Jun 17, 2026

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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