NCT05851391 buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest
| NCT ID | NCT05851391 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University of California, San Francisco |
| Condition | Hypoxia-Ischemia, Brain |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2023-08-07 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 30 participants in total. It began in 2023-08-07 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 epilepticus treatment.
Eligibility Criteria
Inclusion Criteria: 1. Age ≥18 years old 2. Non-traumatic, out-of-hospital cardiac arrest 3. Comatose on admission - defined as not following commands 4. Return of spontaneous circulation (ROSC) within less than 45 minutes 5. Admission to the intensive care unit 6. Diagnosis of post-cardiac arrest refractory status epilepticus confirmed with continuous EEG monitoring within 7 days from ROSC Exclusion Criteria: 1. Acute cerebral hemorrhage or infarction 2. Pregnancy 3. Prisoners
Contact & Investigator
Edilberto Amorim, MD
PRINCIPAL INVESTIGATOR
Assistant Professor of Neurology
Frequently Asked Questions
Who can join the NCT05851391 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Hypoxia-Ischemia, Brain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05851391 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT05851391 currently recruiting?
Yes, NCT05851391 is actively recruiting participants. Contact the research team at restorestudy@ucsf.edu for enrollment information.
Where is the NCT05851391 trial being conducted?
This trial is being conducted at San Francisco, United States.
Who is sponsoring the NCT05851391 clinical trial?
NCT05851391 is sponsored by University of California, San Francisco. The principal investigator is Edilberto Amorim, MD at Assistant Professor of Neurology. The trial plans to enroll 30 participants.