Status Epilepticus Population Study (STEPS)

Recruiting

• Conditions: Epileptic Seizures
• Interventions: Other: collection of patient data

• Registration Number: NCT04204863
• Lead Sponsor: University Hospital, Basel, Switzerland

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-19
• Study First Submitted: 2019-12-17
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-19
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-14
• Primary Completion: 2050-12
• Study Completion: 2050-12

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 1000

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
SE patients	collection of patient data	-

Primary Outcome Measures

Name	Time	Method
Data from acute prehospital management by the emergency medical services (EMS)	between 01.01.2005 and 31.12.2023	extracted from the treatment protocols of the EMS
Demographics	between 01.01.2005 and 31.12.2023	age, sex
Seizure history and etiology	between 01.01.2005 and 31.12.2023	withdrawal from anti seizure drugs, structural, infectious, or autoimmune causes
Duration of ICU (intensive care unit) and hospital stay, and destination at discharge	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	between 01.01.2005 and 31.12.2023	Date(s) of seizure(s) captured by EEG
Number and Duration of SE episodes	between 01.01.2005 and 31.12.2023	Number and Duration (time) of SE episodes
Types of SE	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	between 01.01.2005 and 31.12.2023	length, level of consciousness at onset, previous epileptic seizures
Clinical neurologic monitoring scores	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	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
Therapeutic features	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	between 01.01.2005 and 31.12.2023	blood pressure, heart rate, respiratory rate, oxygen saturation of the blood, body temperature, level of consciousness
ICU Scoring Systems	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.)
Outcome measure	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

Trial Locations

Locations (2)

Clinic for Intensive Care Medicine, University Hospital Basel; 🇨🇭 Basel, Switzerland

Cantonal Hospital Aarau (KSA); 🇨🇭 Aarau, Switzerland