Refractory Status EpilepticusI-SeizureNCT05830864
Multicenter Retrospective Study of Isoflurane in Refractory and Super-Refractory Status Epilepticus
An observational study of Refractory Status Epilepticus, run by Hopital of Melun at 4 sites in France.
Trial summary
Isoflurane might be used as anticonvulsive therapy in refractory status epilepticus. The aim of the study is to assess the efficiency of Isoflurane in this indication. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Refractory Status Epilepticus
- What is being tested?
- Isoflurane
- How many people
- 66 participants
- Where
- 4 sitesFrance
- Study dates
- 30 Jun 2024to 22 Sep 2025
- How long will I take part?
- 28 Days
- 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: All patients with eligibility criteria in the sites of study will be included int the study
Who may be able to join
- Age > 18 years, hospitalized in ICU between 2016-01-01 and 2023-01-01, suffering refractory status epilepticus treated by inhaled Isoflurane as third anticonvulsive therapy
Who cannot join
- post-anoxic refractory status epilepticus after cardiac arrest, withdrawal of consent for medical data use
Trial locations and contacts
4 sites in 1 country.
France4 sites
Ch Bethune Beuvry
Beuvry, 62660
CHU Brest
Brest, 29200
GH Sud Ile de France, Hôpital de Melun-Sénart
Melun, 77000
CH Toulon - Sainte Musse
Toulon, 83000
About this study
Official title: Multicenter Retrospective Study of Isoflurane in Refractory and Super-Refractory Status Epilepticus (I-Seizure)
Isoflurane might be used as anticonvulsive therapy in refractory status epilepticus. The aim of the study is to assess the efficiency of Isoflurane in this indication.
Read the detailed description
Investigators will collect in 4 ICUs the data from consecutive patients hospitalized between january 2016 and january 2023. Included patient were those treated by Isoflurane for refractory status epilepticus.
- Conditions
- Refractory Status Epilepticus
- Being tested
- Isoflurane
- Keywords
- Isoflurane
- Medical subject headings
- Status Epilepticus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsofluraneDrug
no other intervention
| Study group | Role | What they receive |
|---|---|---|
| Main cohort | Adult patients with refractory status epilepticus treated by Isoflurane as third anticonvulsive therapy Receives: Drug: Isoflurane |
What is being measured
The primary outcome is the main question the study is designed to answer.
rate of crisis control
rate of patients with crisis control or complete awakening
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2023
- Study start30 Jun 2024
- Primary completion22 Sep 2025
- Study completion22 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Refractory Status EpilepticusStudies of the same condition, open and under way.
- 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
- Prospective
- Enrolment
- 66 participants (actual)
- Target duration
- 28 Days
Sponsor and investigators
- Lead sponsor
- Hopital of Melun
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sebastien Jochmans, MD, Hopital of Melun
- Investigators
- SEBASTIEN JOCHMANS, MD, Study director, GHSIF MELUN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05830864
- Sponsor's protocol ID
- MIR-2023-01
- Acronym
- I-Seizure
- Status last verified
- Sep 2025
- First submitted
- 31 Mar 2023
- Last updated
- 26 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: After study completion, on justified demand and after review board authorization
Publications
Meiser A, Volk T, Wallenborn J, Guenther U, Becher T, Bracht H, Schwarzkopf K, Knafelj R, Faltlhauser A, Thal SC, Soukup J, Kellner P, Druner M, Vogelsang H, Bellgardt M, Sackey P; Sedaconda study group. Inhaled isoflurane via the anaesthetic conserving device versus propofol for sedation of invasively ventilated patients in intensive care units in Germany and Slovenia: an open-label, phase 3, randomised controlled, non-inferiority trial. Lancet Respir Med. 2021 Nov;9(11):1231-1240. doi: 10.1016/S2213-2600(21)00323-4. Epub 2021 Aug 26.
PubMed 34454654Stetefeld HR, Schaal A, Scheibe F, Nichtweiss J, Lehmann F, Muller M, Gerner ST, Huttner HB, Luger S, Fuhrer H, Bosel J, Schonenberger S, Dimitriadis K, Neumann B, Fuchs K, Fink GR, Malter MP; IGNITE Study Group, with support from the German Neurocritical Care Society (DGNI). Isoflurane in (Super-) Refractory Status Epilepticus: A Multicenter Evaluation. Neurocrit Care. 2021 Dec;35(3):631-639. doi: 10.1007/s12028-021-01250-z. Epub 2021 Jul 20.
PubMed 34286464
Study at a glance
From the registry record, last updated by the sponsor on 26 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Retrospective Study of Isoflurane in Refractory and Super-Refractory Status Epilepticus (I-Seizure)
- ClinicalTrials.gov ID
- NCT05830864
- Acronym / sponsor ID
- I-Seizure / MIR-2023-01
- Conditions
- Refractory Status Epilepticus
- Keywords
- Isoflurane
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- Hopital of MelunUniversity, hospital or other
- Study start
- 30 Jun 2024 (actual)
- Primary completion
- 22 Sep 2025 (actual)
- Study completion
- 22 Sep 2025 (actual)
- First posted
- 26 Apr 2023 (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.
Isoflurane might be used as anticonvulsive therapy in refractory status epilepticus. The aim of the study is to assess the efficiency of Isoflurane in this indication.
Detailed description
Investigators will collect in 4 ICUs the data from consecutive patients hospitalized between january 2016 and january 2023. Included patient were those treated by Isoflurane for refractory status epilepticus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 28 Days
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Main cohort | – | Drug: IsofluraneAdult patients with refractory status epilepticus treated by Isoflurane as third anticonvulsive therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All patients with eligibility criteria in the sites of study will be included int the study
Key inclusion criteria (1 listed)
- Age > 18 years, hospitalized in ICU between 2016-01-01 and 2023-01-01, suffering refractory status epilepticus treated by inhaled Isoflurane as third anticonvulsive therapy
Key exclusion criteria (1 listed)
- post-anoxic refractory status epilepticus after cardiac arrest, withdrawal of consent for medical data use
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 |
|---|---|---|
| Isofluraneno other intervention | Drug | Main cohort |
Primary outcome
rate of crisis control
Time frame: 3 months
rate of patients with crisis control or complete awakening
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 Sep 2025.
- Results publication: PubMed 34454654Meiser A, Volk T, Wallenborn J, Guenther U, Becher T, Bracht H, Schwarzkopf K, Knafelj R, Faltlhauser A, Thal SC, Soukup J, Kellner P, Druner M, Vogelsang H, Bellgardt M, Sackey P; Sedaconda study group. Inhaled isoflurane via the anaesthetic conserving device versus propofol for sedation of invasively ventilated patients in intensive care units in Germany and Slovenia: an open-label, phase 3, randomised controlled, non-inferiority trial. Lancet Respir Med. 2021 Nov;9(11):1231-1240. doi: 10.1016/S2213-2600(21)00323-4. Epub 2021 Aug 26.
- Results publication: PubMed 34286464Stetefeld HR, Schaal A, Scheibe F, Nichtweiss J, Lehmann F, Muller M, Gerner ST, Huttner HB, Luger S, Fuhrer H, Bosel J, Schonenberger S, Dimitriadis K, Neumann B, Fuchs K, Fink GR, Malter MP; IGNITE Study Group, with support from the German Neurocritical Care Society (DGNI). Isoflurane in (Super-) Refractory Status Epilepticus: A Multicenter Evaluation. Neurocrit Care. 2021 Dec;35(3):631-639. doi: 10.1007/s12028-021-01250-z. Epub 2021 Jul 20.
- Individual participant dataSharing planned: Undecided. After study completion, on justified demand and after review board authorization
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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.
SEBASTIEN JOCHMANS, MD study director
GHSIF MELUN
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Refractory Status Epilepticus, run by Hopital of Melun at 4 sites in France.
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 1 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 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in France. 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?
rate of crisis control (time frame: 3 months). 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 NCT05830864, which also lists 2 linked publications.
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 Sep 2025.