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RecruitingNCT04204863Updated Jun 17, 2026

Status Epilepticus Population Study (STEPS)

An observational study in Epileptic Seizures, sponsored by University Hospital, Basel, Switzerland. Recruiting at 2 sites in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-17.

Primary conditionStatus EpilepticusRegistry: SeizuresReclassifiedWhy we changed it
Registry
Seizures — the first condition term the registry derived for this study.
ClinicalTrials.gg
Status Epilepticus
Why
  1. The study's title name Status Epilepticus, a narrower term within Seizures.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University Hospital, Basel, Switzerland · Observational

From the registry’s dates

  • Started Apr 2019; still recruiting 7 years 6 months later.
Study type
Observational
Model
Cohort
Time perspective
Retrospective
Enrollment
1,000
Ages
18 Years and older
Sex
All
01

Study summary

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).

02

Conditions studied

  • Epileptic Seizures

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Keywords

  • Status epilepticus
  • Electroencephalogram
03

In context

Status Epilepticus Reclassified

124 studies on the registry are indexed under Status Epilepticus; 37 are open to participants now.

This study's planned enrollment of 1,000 is above the median of 156 across 42 observational studies indexed under Status Epilepticus.

Browse Status Epilepticus studies →

Lead sponsor

University Hospital, Basel, Switzerland is the lead sponsor of 990 studies on the registry; 189 are open to participants now.

Compared within Status Epilepticus, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Seizures. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Adult patients (i.e., patients ≥18 years of age) with SE treated at the University Hospital Basel and the Cantonal Hospital Aarau.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • Patients younger than 18 years.
  • Patients with repetitive epileptic seizures not qualifying for SE.
  • Patients with documented refusal of the general consent.
05

Study design

Observational model
Cohort
Time perspective
Retrospective
Enrollment
1,000 participants (estimated)
Patient registry
No

Groups and cohorts

  • SE patients

    Other: collection of patient data

Interventions

  • Othercollection of patient data

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

06

What researchers measure

Primary outcomes

  1. Demographics

    age, sex

    Time frame: between 01.01.2005 and 31.12.2023

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

    extracted from the treatment protocols of the EMS

    Time frame: between 01.01.2005 and 31.12.2023

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

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

    Time frame: between 01.01.2005 and 31.12.2023

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

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

    Time frame: between 01.01.2005 and 31.12.2023

  5. Seizure history and etiology

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

    Time frame: between 01.01.2005 and 31.12.2023

  6. Number and Duration of SE episodes

    Number and Duration (time) of SE episodes

    Time frame: between 01.01.2005 and 31.12.2023

  7. Types of SE

    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

    Time frame: between 01.01.2005 and 31.12.2023

  8. Additional features of the seizure

    length, level of consciousness at onset, previous epileptic seizures

    Time frame: between 01.01.2005 and 31.12.2023

  9. ICU Scoring Systems

    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.)

    Time frame: between 01.01.2005 and 31.12.2023

  10. Clinical neurologic monitoring scores

    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))

    Time frame: between 01.01.2005 and 31.12.2023

  11. Laboratory parameters

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

    Time frame: between 01.01.2005 and 31.12.2023

  12. Outcome measure

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

    Time frame: between 01.01.2005 and 31.12.2023

  13. Therapeutic features

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

    Time frame: between 01.01.2005 and 31.12.2023

  14. Monitoring of vital signs

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

    Time frame: between 01.01.2005 and 31.12.2023

07

Study locations

2 of 2 sites recruiting
08

References and documents

Publications

  • Fisch U, Junger AL, Baumann SM, Semmlack S, De Marchis GM, Ruegg SJ, Hunziker S, Marsch S, Sutter R. Association Between Dose Escalation of Anesthetics and Outcomes in Patients With Refractory Status Epilepticus. Neurology. 2024 Jan 23;102(2):e207995. doi: 10.1212/WNL.0000000000207995. Epub 2023 Dec 15. PubMed 38165316 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04204863
Responsible party
Sponsor
First posted
Dec 19, 2019
Start date
Apr 19, 2019
Primary completion
Dec 2050 (estimated)
Completion
Dec 2050 (estimated)
Last update
Jun 17, 2026

Study contacts

Raoul Sutter, PD Dr. med
Contact
Raoul.Sutter@usb.ch
+41 61 265 25 25
Saskia Semmlack, Dr. med
Contact
Saskia.Semmlack@usb.ch
+41 61 55 65575
Raoul Sutter, PD Dr. med
principal investigator · Clinic for Intensive Care Medicine, University Hospital Basel

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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