Actively Recruiting
buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest (RESTORE) Phase II Clinical Trial Evaluating EEG-Guided Anesthetic Treatments
Led by University of California, San Francisco · Updated on 2025-05-15
30
Participants Needed
1
Research Sites
21 weeks
Total Duration
On this page
Sponsors
U
University of California, San Francisco
Lead Sponsor
T
The ZOLL Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the safety and feasibility of two EEG-guided treatment strategies for controlling refractory status epilepticus after cardiac arrest. This Phase II clinical trial focuses on unconscious patients who have been resuscitated from cardiac arrest but develop seizures that are resistant to standard anti-seizure medications. The study aims to determine whether guiding anesthetic treatment to achieve burst suppression or seizure suppression on EEG is more effective for seizure control in this critical condition. Participants will be randomly assigned to one of two groups. One group will receive intravenous anesthesia adjusted to produce burst suppression on continuous EEG for 24 hours, while the other group will receive anesthesia aimed at seizure suppression on EEG for the same duration. If seizures recur, the assigned EEG target treatment may be repeated for another 24-hour cycle. After the treatment periods, anesthetics will be tapered with continued EEG monitoring. During the study, researchers will closely monitor seizure control, neurological function at discharge and up to 180 days later, seizure recurrence, and treatment intensity. Safety monitoring includes watching for side effects like low blood pressure and metabolic complications related to anesthetics. The total study duration includes initial treatment and follow-up assessments to evaluate outcomes such as death or disability and seizure recurrence within specified timeframes.
CONDITIONS
Brief Title
buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Experienced non-traumatic cardiac arrest outside of a hospital
- Unconscious and not following commands on admission
- Return of spontaneous circulation within 45 minutes
- Admitted to the intensive care unit
- Diagnosed with post-cardiac arrest refractory status epilepticus confirmed by continuous EEG within 7 days of return of circulation
You will not qualify if you...
- Acute cerebral hemorrhage or stroke
- Pregnancy
- Prisoner status
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 7 days after return of circulation
Participants are screened for eligibility to participate in the trial.
1 visit (in-person) for continuous EEG monitoring
Duration - 24 to 48 hours, including possible repeat treatment cycle if seizures recur
Participants receive intravenous anesthetic treatment guided by continuous EEG to achieve either burst suppression or seizure suppression for post-cardiac arrest refractory status epilepticus control.
Continuous monitoring during treatment period in intensive care
Duration - Up to 180 days
Participants are monitored for neurological function and seizure recurrence up to 180 days after treatment.
Assessments at discharge, 30 days, 90 days, and 180 days post-treatment
Trial Site Locations
Total: 1 location
1
Zuckerberg San Francisco General Hospital
San Francisco, California, United States, 94110
Actively Recruiting
Research Team
E
Edilberto Amorim, MD
K
Kevin Bao
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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