Status EpilepticusRESETNCT04333082
Refractory Status Epilepticus Treatment: Quality and Efficacy of Coma Induction
An observational study of Status Epilepticus and Refractory Status Epilepticus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Status Epilepticus, Refractory Status Epilepticus
- What is being tested?
- Data collection
- How many people
- 147 participants
- Where
- 1 siteSwitzerland
- Study dates
- 22 Apr 2020to 3 Aug 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- diagnosed SE between 2005 and 2019 who have been treated at intensive care units (ICUs) of the University Hospital of Basel
Who cannot join
- Patients with repetitive epileptic seizures not qualifying for SE or RSE
- Patients with documented refusal of the general in-house consent
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Clinic for Intensive Care Medicine, University Hospital Basel
Basel, 4031
About this study
Official title: Refractory Status Epilepticus Treatment (RESET): 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.
- Conditions
- Status Epilepticus, Refractory Status Epilepticus
- Being tested
- Data collection
- Keywords
- artificial deep coma, intravenous anesthetic drugs (IVADs), total seizure oppression
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
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
What is being measured
The primary outcome is the main question the study is designed to answer.
number of in- hospital death
number of in- hospital death
Measured: at baseline (T0)
Secondary outcomes (1)
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
Measured: at baseline (T0)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2020
- Study start22 Apr 2020
- Primary completion15 Aug 2021
- Study completion3 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Status EpilepticusStudies of the same condition, open and under way.
- More trials run by University Hospital, Basel, SwitzerlandThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 147 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raoul Sutter, PD Dr. med, Principal investigator, Universitätsspital Basel / Intensivmedizin
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04333082
- Sponsor's protocol ID
- 2020-00538; me20Sutter
- Acronym
- RESET
- Status last verified
- Feb 2024
- First submitted
- 31 Mar 2020
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 36889924
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Refractory Status Epilepticus Treatment (RESET): Quality and Efficacy of Coma Induction
- ClinicalTrials.gov ID
- NCT04333082
- Acronym / sponsor ID
- RESET / 2020-00538; me20Sutter
- Conditions
- Status Epilepticus, Refractory Status Epilepticus
- Keywords
- artificial deep coma, intravenous anesthetic drugs (IVADs), total seizure oppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 147 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Study start
- 22 Apr 2020 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 3 Aug 2022 (actual)
- First posted
- 3 Apr 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (1 listed)
- diagnosed SE between 2005 and 2019 who have been treated at intensive care units (ICUs) of the University Hospital of Basel
Key exclusion criteria (2 listed)
- Patients with repetitive epileptic seizures not qualifying for SE or RSE
- Patients with documented refusal of the general in-house consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Data collectioncollection 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 | Other | – |
Primary outcome
number of in- hospital death
Time frame: at baseline (T0)
number of in- hospital death
1 secondary outcome
neurofunctional alteration assessed by Glasgow Outcome Score (GOS)
Time frame: at baseline (T0)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Results publication: PubMed 36889924Fisch 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raoul Sutter, PD Dr. med principal investigator
Universitätsspital Basel / Intensivmedizin
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Status Epilepticus and Refractory Status Epilepticus, run by University Hospital, Basel, Switzerland at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
number of in- hospital death (time frame: at baseline (T0)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04333082, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2024.