Epileptic SeizuresNCT04204863
Status Epilepticus Population Study (STEPS)
An observational study of Epileptic Seizures, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Epileptic Seizures
- What is being tested?
- collection of patient data
- How many people
- 1,000 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 19 Apr 2019to Dec 2050
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients (i.e., patients ≥18 years of age) with SE treated at the University Hospital Basel and the Cantonal Hospital Aarau.
Who may be able to join
- 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.
Who cannot join
- Patients younger than 18 years.
- Patients with repetitive epileptic seizures not qualifying for SE.
- Patients with documented refusal of the general consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Switzerland2 sites, 2 recruiting
- Recruiting
Cantonal Hospital Aarau (KSA)
Aarau, 5001
Markus Gschwind, PD Dr. med., +41 62 838 66 89, markus.gschwind@ksa.ch
Markus Gschwind, PD Dr. med.
- Recruiting
Clinic for Intensive Care Medicine, University Hospital Basel
Basel, 4031
Raoul Sutter, PD Dr. med, +41 61 265 25 25, raoul.sutter@usb.ch
Saskia Semmlack, Dr. med, +41 61 55 65575, Saskia.Semmlack@usb.ch
About this study
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).
- Conditions
- Epileptic Seizures
- Being tested
- collection of patient data
- Keywords
- Status epilepticus, Electroencephalogram
- Medical subject headings
- Seizures, Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
collection of patient dataOther
Extract data from the digital medical records, the electroencephalographic and microbiologic database.
| Study group | Role | What they receive |
|---|---|---|
| SE patients | Not described Receives: Other: collection of patient data |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demographics
age, sex
Measured: between 01.01.2005 and 31.12.2023
Data from acute prehospital management by the emergency medical services (EMS)
extracted from the treatment protocols of the EMS
Measured: between 01.01.2005 and 31.12.2023
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
Measured: between 01.01.2005 and 31.12.2023
Date(s) of seizure(s) captured by electroencephalographic (EEG) data
Date(s) of seizure(s) captured by EEG
Measured: between 01.01.2005 and 31.12.2023
Seizure history and etiology
withdrawal from anti seizure drugs, structural, infectious, or autoimmune causes
Measured: between 01.01.2005 and 31.12.2023
Number and Duration of SE episodes
Number and Duration (time) of SE episodes
Measured: between 01.01.2005 and 31.12.2023
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
Measured: between 01.01.2005 and 31.12.2023
Additional features of the seizure
length, level of consciousness at onset, previous epileptic seizures
Measured: between 01.01.2005 and 31.12.2023
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.)
Measured: between 01.01.2005 and 31.12.2023
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))
Measured: between 01.01.2005 and 31.12.2023
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
Measured: between 01.01.2005 and 31.12.2023
Outcome measure
in-hospital death, survival, survival with neurofunctional alteration, Glasgow Outcome Score, return to neurofunctional premorbid baseline, readmission
Measured: between 01.01.2005 and 31.12.2023
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
Measured: between 01.01.2005 and 31.12.2023
Monitoring of vital signs
blood pressure, heart rate, respiratory rate, oxygen saturation of the blood, body temperature, level of consciousness
Measured: between 01.01.2005 and 31.12.2023
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2019
- Study start19 Apr 2019
- Primary completionDec 2050 (estimated)
- Study completionDec 2050 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Epileptic SeizuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raoul Sutter, PD Dr. med, Principal investigator, Clinic for Intensive Care Medicine, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04204863
- Sponsor's protocol ID
- 2019-00693; me19Sutter5
- Other IDs
- 2019
- Status last verified
- Jun 2026
- First submitted
- 17 Dec 2019
- Last updated
- 17 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Status Epilepticus Population Study (STEPS)
- ClinicalTrials.gov ID
- NCT04204863
- Acronym / sponsor ID
- 2019-00693; me19Sutter5
- Conditions
- Epileptic Seizures
- Keywords
- Status epilepticus, Electroencephalogram
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- Dec 2050 (estimated)
- Study completion
- Dec 2050 (estimated)
- First posted
- 19 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SE patients | – | Other: collection of patient data |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients (i.e., patients ≥18 years of age) with SE treated at the University Hospital Basel and the Cantonal Hospital Aarau.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (3 listed)
- Patients younger than 18 years.
- Patients with repetitive epileptic seizures not qualifying for SE.
- Patients with documented refusal of the general consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| collection of patient dataExtract data from the digital medical records, the electroencephalographic and microbiologic database. | Other | SE patients |
Primary outcome
Demographics
Time frame: between 01.01.2005 and 31.12.2023
age, sex
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
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
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
Seizure history and etiology
Time frame: between 01.01.2005 and 31.12.2023
withdrawal from anti seizure drugs, structural, infectious, or autoimmune causes
Number and Duration of SE episodes
Time frame: between 01.01.2005 and 31.12.2023
Number and Duration (time) of SE episodes
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
Additional features of the seizure
Time frame: between 01.01.2005 and 31.12.2023
length, level of consciousness at onset, previous epileptic seizures
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.)
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))
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
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
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
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2026.
- Derived from this study: PubMed 38165316Fisch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raoul Sutter, PD Dr. med principal investigator
Clinic for Intensive Care Medicine, University Hospital Basel
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Epileptic Seizures, run by University Hospital, Basel, Switzerland at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 17 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raoul Sutter, PD Dr. med (+41 61 265 25 25, Raoul.Sutter@usb.ch), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demographics (time frame: between 01.01.2005 and 31.12.2023). The study lists 14 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04204863, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Jun 2026.