Refractory Status Epilepticus Treatment: Quality and Efficacy of Coma Induction

Status Epilepticus Clinical Trial

— RESET  

Official title:

Refractory Status Epilepticus Treatment (RESET): Quality and Efficacy of Coma Induction

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04333082
• Other study ID #: 2020-00538; me20Sutter
• Status: Completed
• Start date: April 22, 2020
• Est. completion date: August 3, 2022

Study information

• Verified date: February 2024
• Source: University Hospital, Basel, Switzerland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is to investigate the effects of different treatment characteristics regarding the use of intravenous anesthetic drugs (IVADs) as a rescue treatment for refractory Status epilepticus (RSE) on course and outcome. A retrospective data extraction from the digital medical records, the electroencephalographic and microbiologic database of all consecutive adult patients with Status epilepticus (SE) admitted to the University Hospital Basel is undertaken.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 147
• Est. completion date: August 3, 2022
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• diagnosed SE between 2005 and 2019 who have been treated at intensive care units (ICUs) of the University Hospital of Basel

Exclusion Criteria:

• Patients with repetitive epileptic seizures not qualifying for SE or RSE

• Patients with documented refusal of the general in-house consent

Related Conditions & MeSH terms

• Refractory Status Epilepticus
• Status Epilepticus

Intervention

Other:
• Data collection
collection of patient data Data collection (demographics, prehospital management, duration of ICU and hospital stay, destination at discharge, date(s) of seizure(s), electroencephalographic (EEG) data, seizure history and etiology, number and duration of SE episodes, medication, types of SE according to the current guidelines from the International League of Epilepsy (ILAE), neuroimaging features, comorbidities, laboratory parameters, complications during and after SE , laboratory testing, vital signs, fluid balance) will be performed from the digital medical records, the electroencephalographic and microbiologic database of patients

Locations

Country	Name	City	State
Switzerland	Clinic for Intensive Care Medicine, University Hospital Basel	Basel

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Fisch U, Junger AL, Baumann SM, Semmlack S, De Marchis GM, Hunziker S, Ruegg S, Marsch S, Sutter R. Association Between Induced Burst Suppression and Clinical Outcomes in Patients With Refractory Status Epilepticus: A 9-Year Cohort Study. Neurology. 2023 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	number of in- hospital death	number of in- hospital death	at baseline (T0)
Secondary	neurofunctional alteration assessed by Glasgow Outcome Score (GOS)	neurofunctional alteration assessed by Glasgow Outcome Score (GOS). The Glasgow Outcome Scale (GOS) is a global scale for functional outcome that rates patient status into one of five categories: Dead, Vegetative State, Severe Disability, Moderate Disability or Good Recovery	at baseline (T0)