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Completed

NCT Number: NCT04333082

Refractory Status Epilepticus Treatment: Quality and Efficacy of Coma Induction

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.

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Key information

Conditions

Status Epilepticus Nervous System Diseases Neurologic Manifestations Pathological Conditions, Signs and Symptoms Refractory Status Epilepticus Seizures Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Clinic for Intensive Care Medicine, University Hospital Basel

Basel, 4031, Switzerland

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Data Collection

Other

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

Primary outcomes

  1. number of in- hospital death

    Time frame: at baseline (T0)

    number of in- hospital death

Secondary outcomes

  1. neurofunctional alteration assessed by Glasgow Outcome Score (GOS)

    Time frame: at baseline (T0)

    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

Sponsors and collaborators

Lead sponsor

University Hospital, Basel, Switzerland

Other

Registry information

Official study title

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

Acronym: RESET

Important dates

Study start
2020
Primary completion
2021
Study completion
2022
First posted
Apr 3, 2020
Registry last updated
Feb 26, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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