Status Epilepticus Population Study (STEPS) (STEP UP)

June 15, 2026 updated by: University Hospital, Basel, Switzerland
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Aarau, Switzerland, 5001
        • Recruiting
        • Cantonal Hospital Aarau (KSA)
        • Contact:
        • Principal Investigator:
          • Markus Gschwind, PD Dr. med.
      • Basel, Switzerland, 4031
        • Recruiting
        • Clinic for Intensive Care Medicine, University Hospital Basel
        • Contact:
        • Contact:
        • Sub-Investigator:
          • Sarah Tschudin-Sutter, Prof. Dr. med
        • Sub-Investigator:
          • Sira Baumann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Retrospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
SE patients
Other: collection of patient data
Extract data from the digital medical records, the electroencephalographic and microbiologic database.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Demographics
Time Frame: between 01.01.2005 and 31.12.2023
age, sex
between 01.01.2005 and 31.12.2023
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
between 01.01.2005 and 31.12.2023
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
between 01.01.2005 and 31.12.2023
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
between 01.01.2005 and 31.12.2023
Seizure history and etiology
Time Frame: between 01.01.2005 and 31.12.2023
withdrawal from anti seizure drugs, structural, infectious, or autoimmune causes
between 01.01.2005 and 31.12.2023
Number and Duration of SE episodes
Time Frame: between 01.01.2005 and 31.12.2023
Number and Duration (time) of SE episodes
between 01.01.2005 and 31.12.2023
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
between 01.01.2005 and 31.12.2023
Additional features of the seizure
Time Frame: between 01.01.2005 and 31.12.2023
length, level of consciousness at onset, previous epileptic seizures
between 01.01.2005 and 31.12.2023
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.)
between 01.01.2005 and 31.12.2023
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))
between 01.01.2005 and 31.12.2023
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
between 01.01.2005 and 31.12.2023
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
between 01.01.2005 and 31.12.2023
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
between 01.01.2005 and 31.12.2023
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
between 01.01.2005 and 31.12.2023

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raoul Sutter, PD Dr. med, Clinic for Intensive Care Medicine, University Hospital Basel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 19, 2019

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2050

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2050

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 17, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 19, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 15, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2019-00693; me19Sutter5

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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