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

Part of paid clinical trials in San Francisco, California.

Sponsor
University of California, San Francisco
Study ID
NCT05851391
Phase
PHASE2
Status
Recruiting
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Conditions

  • Anoxia-Ischemia, Cerebral
  • Anoxic-Ischemic Encephalopathy
  • Heart Arrest
  • Hypoxia-Ischemia, Brain
  • Refractory Status Epilepticus
  • Seizures
  • Status Epilepticus

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Burst Suppression EEG Target Intravenous Anesthesia — DRUG
    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.
  • Seizure Suppression EEG Target Intravenous Anesthesia — DRUG
    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.

Study Details

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.

Key Dates

Start date
Aug 7, 2023
Status verified
May 2025
Primary completion
Nov 30, 2026
Completion
Apr 30, 2027

Study Design

Enrollment
30 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Post-cardiac arrest refractory status epilepticus control [ Time Frame: 48 hours ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Zuckerberg San Francisco General HospitalSan FranciscoCalifornia94110
Edilberto Amorim, MD

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Zuckerberg San Francisco General Hospital· San Francisco, CA

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