Status Epilepticus Population Study (STEPS)

NCT04204863 | Recruiting

• 1 other identifier: 2019-00693; me19Sutter5
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

Brief 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).

Conditions

Epileptic Seizures

Keywords

Status epilepticus; Electroencephalogram

Outcome Measures

Primary Outcomes (14)

• Demographics

  age, sex

  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

  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

  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

  between 01.01.2005 and 31.12.2023

• Seizure history and etiology

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

  between 01.01.2005 and 31.12.2023

• Number and Duration of SE episodes

  Number and Duration (time) of SE episodes

  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

  between 01.01.2005 and 31.12.2023

• Additional features of the seizure

  length, level of consciousness at onset, previous epileptic seizures

  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.)

  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))

  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

  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

  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

  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

  between 01.01.2005 and 31.12.2023

Study Arms (1)

SE patients

Other: collection of patient data

Interventions

collection of patient data OTHER

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

SE patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (2)

Cantonal Hospital Aarau (KSA)

Aarau, 5001, Switzerland

RECRUITING

Clinic for Intensive Care Medicine, University Hospital Basel

Basel, 4031, Switzerland

RECRUITING

MeSH Terms

Conditions

Seizures; Status Epilepticus

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Raoul Sutter, PD Dr. med

  Clinic for Intensive Care Medicine, University Hospital Basel

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Raoul Sutter, PD Dr. med

CONTACT

+41 61 265 25 25; Raoul.Sutter@usb.ch

Saskia Semmlack, Dr. med

CONTACT

+41 61 55 65575; Saskia.Semmlack@usb.ch

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2019
• First Posted: December 19, 2019
• Study Start: April 19, 2019
• Primary Completion (Estimated): December 1, 2050
• Study Completion (Estimated): December 1, 2050
• Last Updated: February 14, 2025

Record last verified: 2025-02

Locations

CH (2)