Multicenter Retrospective Study of Isoflurane in Refractory and Super-Refractory Status Epilepticus

Refractory Status Epilepticus Clinical Trial

— I-Seizure  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05830864
• Other study ID #: MIR-2023-01
• Status: Not yet recruiting
• Start date: March 1, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: February 2024
• Source: Hopital of Melun
• Contact: SEBASTIEN JOCHMANS, MD
• Phone: 0181742078
• Email: sebastien.jochmans[@]ghsif.fr
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 120
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Refractory Status Epilepticus
• Status Epilepticus

Intervention

Drug:
• Isoflurane
no other intervention

Locations

Country	Name	City	State
France	Ch Bethune Beuvry	Beuvry
France	CHU Brest	Brest
France	GH Sud Ile de France, Hôpital de Melun-Sénart	Melun
France	CH Toulon - Sainte Musse	Toulon

Sponsors (1)

Lead Sponsor	Collaborator
Hopital of Melun

Country where clinical trial is conducted

France, 

References & Publications (2)

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 d — View Citation

Stetefeld 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	rate of crisis control	rate of patients with crisis control or complete awakening	3 months