buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest (RESTORE)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
RESTORE is a randomized clinical trial investigating the safety and feasibility of using EEG treatment targets (burst suppression vs. seizure suppression) for post-cardiac arrest refractory status epilepticus treatment.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Age ≥18 years old
• Non-traumatic, out-of-hospital cardiac arrest
• Comatose on admission - defined as not following commands
• Return of spontaneous circulation (ROSC) within less than 45 minutes
• Admission to the intensive care unit
• Diagnosis of post-cardiac arrest refractory status epilepticus confirmed with continuous
⁃ EEG monitoring within 7 days from ROSC
Locations
United States
California
Zuckerberg San Francisco General Hospital
RECRUITING
San Francisco
Contact Information
Primary
Edilberto Amorim, MD
restorestudy@ucsf.edu
628-206-3203
Backup
Kevin Bao
restorestudy@ucsf.edu
(415)514-2120
Time Frame
Start Date: 2023-08-07
Estimated Completion Date: 2027-04-30
Participants
Target number of participants: 30
Treatments
Other: Burst Suppression EEG Target
Anesthetic will be titrated to achieve burst suppression on continuous EEG (50-99% attenuation/suppression) for 24 hours.
Other: Seizure Suppression EEG Target
Anesthetic will be titrated to achieve seizure suppression on continuous EEG for 24 hours.
Related Therapeutic Areas
Sponsors
Leads: University of California, San Francisco
Collaborators: The ZOLL Foundation