RecruitingPhase 2NCT05851391

buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest

buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest (RESTORE)


Sponsor

University of California, San Francisco

Enrollment

30 participants

Start Date

Aug 7, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

The RESTORE trial addresses one of the most difficult situations in post-cardiac arrest care: refractory status epilepticus — continuous, uncontrollable seizures in comatose patients who have been successfully resuscitated but whose brains are in a state of dangerous electrical storm. This trial tests whether deliberately inducing burst suppression — a deeply suppressed brain state created with anesthetic medications — can stop these seizures and improve survival and neurological outcomes. The rationale is that halting the electrical storm early may prevent additional brain damage. Adults (18+) who experienced out-of-hospital cardiac arrest without a traumatic cause, were resuscitated within 45 minutes, were admitted to ICU in a coma, and developed confirmed refractory status epilepticus on continuous EEG monitoring within 7 days are eligible. Patients with acute brain bleeding or stroke, pregnancy, and prisoners are excluded. Post-cardiac arrest seizures that don't respond to standard medications are associated with near-universal poor outcomes. There is currently no proven treatment. This trial takes an aggressive approach — essentially using heavy sedation to quiet the brain entirely — to try to break the seizure cycle. If it works, it could give some of the most critically ill cardiac arrest survivors a fighting chance at neurological recovery, which would be a significant advance in resuscitation medicine.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGBurst Suppression EEG Target Intravenous Anesthesia

The objective of the burst suppression EEG target is to stop seizures by titrating the anesthetic infusion to suppress most of the EEG background (\>50% suppressed/attenuated). After this 24-hour period, this target would be continued for 24 hours. The anesthetic will then be tapered under EEG monitoring. In case of PCARSE recurrence, the intervention with the same target will be re-initiated for another cycle of 24 hours.

DRUGSeizure Suppression EEG Target Intravenous Anesthesia

is to stop seizures by titrating the anesthetic infusion without suppressing most of the EEG background. This target would be continued for 24 hours. After this 24-hours period, this target would be continued for 24 hours. The anesthetic will then be tapered under EEG monitoring. In case of PCARSE recurrence, the intervention with the same target will be re-initiated for another cycle of 24 hours.


Locations(1)

Zuckerberg San Francisco General Hospital

San Francisco, California, United States

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NCT05851391


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