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Clinical Trials/NCT04204863
NCT04204863
Recruiting
Not Applicable

Status Epilepticus Population Study (STEPS)

University Hospital, Basel, Switzerland2 sites in 1 country1,000 target enrollmentApril 19, 2019

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Epileptic Seizures
Sponsor
University Hospital, Basel, Switzerland
Enrollment
1000
Locations
2
Primary Endpoint
Demographics
Status
Recruiting
Last Updated
last year

Overview

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).

Registry
clinicaltrials.gov
Start Date
April 19, 2019
End Date
December 2050
Last Updated
last year
Study Type
Observational
Sex
All

Investigators

Sponsor
University Hospital, Basel, Switzerland
Responsible Party
Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Demographics

Time Frame: between 01.01.2005 and 31.12.2023

age, sex

Seizure history and etiology

Time Frame: between 01.01.2005 and 31.12.2023

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

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

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

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

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

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.)

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

Study Sites (2)

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