Status:
RECRUITING
buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest
Lead Sponsor:
University of California, San Francisco
Collaborating Sponsors:
The ZOLL Foundation
Conditions:
Hypoxia-Ischemia, Brain
Heart Arrest
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 epi...
Detailed Description
Rationale: Seizures emerge as a complication of hypoxic-ischemic brain injury in near a third of patients successfully resuscitated from cardiac arrest. Seizures post-cardiac arrest can be refractory ...
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- Acute cerebral hemorrhage or infarction
- Pregnancy
- Prisoners
Key Trial Info
Start Date :
August 7 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 30 2027
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT05851391
Start Date
August 7 2023
End Date
April 30 2027
Last Update
May 15 2025
Active Locations (1)
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1
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110