Refractory Status Epilepticus Treatment: Quality and Efficacy of Coma Induction

NCT04333082 | Completed

• 1 other identifier: 2020-00538; me20Sutter
• Study Type: observational
• Target: 147
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Status Epilepticus; Refractory Status Epilepticus

Keywords

artificial deep coma; intravenous anesthetic drugs (IVADs); total seizure oppression

Outcome Measures

Primary Outcomes (1)

• number of in- hospital death

  number of in- hospital death

  at baseline (T0)

Secondary Outcomes (1)

• neurofunctional alteration assessed by Glasgow Outcome Score (GOS)

  at baseline (T0)

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Adult patients (i.e., patients ≥18 years of age) with diagnosed SE between 2005 and 2019 who have been treated at intensive care units (ICUs) of the University Hospital of Basel, a Swiss tertiary academic medical care center

You may qualify if:

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

You may not qualify if:

• Patients with repetitive epileptic seizures not qualifying for SE or RSE
• Patients with documented refusal of the general in-house consent

Sponsors & Collaborators

• University Hospital, Basel, Switzerland: lead

Study Sites (1)

Clinic for Intensive Care Medicine, University Hospital Basel

Basel, 4031, Switzerland

Location

Related 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 May 9;100(19):e1955-e1966. doi: 10.1212/WNL.0000000000207129. Epub 2023 Mar 8.

  PMID: 36889924 RESULT

MeSH Terms

Conditions

Status Epilepticus

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Seizures; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Raoul Sutter, PD Dr. med

  Universitätsspital Basel / Intensivmedizin

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 31, 2020
• First Posted: April 3, 2020
• Study Start: April 22, 2020
• Primary Completion: August 15, 2021
• Study Completion: August 3, 2022
• Last Updated: February 26, 2024

Record last verified: 2024-02

Locations

CH (1)