Multicenter Retrospective Study of Isoflurane in Refractory and Super-Refractory Status Epilepticus (I-Seizure)

February 22, 2024 updated by: Sebastien Jochmans, MD, Hopital of Melun

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • France
      • Beuvry, France, 62660
        • Ch Bethune Beuvry
        • Contact:
          • Christophe Vinsonneau, MD
      • Brest, France, 29200
        • CHU Brest
        • Contact:
          • Pierre Bailly, MD
      • Melun, France, 77000
        • GH Sud Ile de France, Hôpital de Melun-Sénart
        • Contact:
          • Louis-Marie Coupry, MD
      • Toulon, France, 83000
        • CH Toulon - Sainte Musse
        • Contact:
          • Jonathan Chelly, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients with eligibility criteria in the sites of study will be included int the study

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Main cohort
Adult patients with refractory status epilepticus treated by Isoflurane as third anticonvulsive therapy
Drug: Isoflurane
no other intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
rate of crisis control
Time Frame: 3 months
rate of patients with crisis control or complete awakening
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital of Melun

Investigators

  • Study Director: SEBASTIEN JOCHMANS, MD, GHSIF MELUN

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2024

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

March 31, 2023

First Submitted That Met QC Criteria

April 13, 2023

First Posted (Actual)

April 26, 2023

Study Record Updates

Last Update Posted (Estimated)

February 23, 2024

Last Update Submitted That Met QC Criteria

February 22, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MIR-2023-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

After study completion, on justified demand and after review board authorization

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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