Status Epilepticus Unicenter Population (STEP UP) Study (STEP UP)

The aim of this observational single-center 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: Recruiting
• Conditions: Epileptic Seizures
• Intervention / Treatment: Other: collection of patient data

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Raoul Sutter, PD Dr. med; Phone Number: +41 61 265 25 25; Email: raoul.sutter@usb.ch
• Study Contact Backup: Name: Saskia Semmlack, Dr. med; Phone Number: +41 61 55 65575; Email: Saskia.Semmlack@usb.ch

Study Locations

• Switzerland
  • Basel, Switzerland, 4031
    • Recruiting
    • Clinic for Intensive Care Medicine, University Hospital Basel
    • Contact: Raoul Sutter, PD Dr. med; Phone Number: +41 61 265 25 25; Email: raoul.sutter@usb.ch
    • Contact: Saskia Semmlack, Dr. med; Phone Number: +41 61 55 65575; Email: Saskia.Semmlack@usb.ch
    • Sub-Investigator: Sarah Tschudin-Sutter, Prof. Dr. med
    • Sub-Investigator: Sira Baumann

Participation Criteria

Eligibility Criteria

• 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.

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.

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

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University Hospital, Basel, Switzerland
• Investigators: Principal Investigator: Raoul Sutter, PD Dr. med, Clinic for Intensive Care Medicine, University Hospital Basel

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2019
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: December 17, 2019
• First Submitted That Met QC Criteria: December 17, 2019
• First Posted (Actual): December 19, 2019

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Keywords: Electroencephalogram; Status epilepticus
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurologic Manifestations; Epilepsy; Seizures; Status Epilepticus
• Other Study ID 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