I-Seizure: Multicenter Retrospective Study of Isoflurane in Refractory and Super-Refractory Status Epilepticus
Sponsor
Hopital of Melun (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05830864
Collaborator
(none)
120
4
10
30
3
Study Details
Study Description
Brief 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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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
Study Type:
Observational [Patient Registry]
Anticipated Enrollment
:
120 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Multicenter Retrospective Study of Isoflurane in Refractory and Super-Refractory Status Epilepticus (I-Seizure)
Anticipated Study Start Date
:
May 1, 2023
Anticipated Primary Completion Date
:
Dec 1, 2023
Anticipated Study Completion Date
:
Mar 1, 2024
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Main cohort Adult patients with refractory status epilepticus treated by Isoflurane as third anticonvulsive therapy |
Drug: Isoflurane
no other intervention
|
Outcome Measures
Primary Outcome Measures
- rate of crisis control [3 months]
rate of patients with crisis control or complete awakening
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- 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
Exclusion Criteria:
- post-anoxic refractory status epilepticus after cardiac arrest, withdrawal of consent for medical data use
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Ch Bethune Beuvry | Beuvry | France | 62660 | |
| 2 | CHU Brest | Brest | France | 29200 | |
| 3 | GH Sud Ile de France, Hôpital de Melun-Sénart | Melun | France | 77000 | |
| 4 | CH Toulon - Sainte Musse | Toulon | France | 83000 |
Sponsors and Collaborators
- Hopital of Melun
Investigators
- Study Director: SEBASTIEN JOCHMANS, MD, GHSIF MELUN
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.Responsible Party:
Sebastien Jochmans, MD,
Director of Clinical Research Unit,
Hopital of Melun
ClinicalTrials.gov Identifier:
NCT05830864
Other Study ID Numbers:
- MIR-2023-01
First Posted:
Apr 26, 2023
Last Update Posted:
Apr 26, 2023
Last Verified:
Apr 1, 2023
Individual Participant Data (IPD) Sharing Statement:
Undecided
Plan to Share IPD:
Undecided
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Keywords provided by Sebastien Jochmans, MD,
Director of Clinical Research Unit,
Hopital of Melun
Additional relevant MeSH terms: