buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Burst Suppression EEG Target Intravenous Anesthesia, Seizure Suppression EEG Target Intravenous Anesthesia.
- Who it may be relevant to
- Registry conditions: Hypoxia-Ischemia, Brain, Heart Arrest, Status Epilepticus, Refractory Status Epilepticus. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest (RESTORE)
Overview
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.
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 to treatment with anti-seizure medications and anesthetics may be used for refractory status epilepticus control. Anesthetic treatment guided by continuous EEG can target burst suppression or seizure suppression, however it is not known which strategy is superior for achieving PCARSE control.
Objective: determine the safety and feasibility of post-cardiac arrest refractory status epilepticus (PCARSE) treatment using EEG goals for intravenous anesthetic titration (burst suppression vs. seizure suppression).
Clinical Trial Phase: II
Study Design: prospective, randomized, open-label, blinded end-point, concurrently-controlled, parallel arms design clinical trial.
Study Period: two years
Study Population: unconscious cardiac arrest survivors with return of spontaneous circulation who develop post-cardiac arrest refractory status epilepticus (PCARSE).
Interventions: anesthetic use targeting burst suppression vs. seizure suppression on EEG for 24 hours. Intervention maybe repeated using the dame EEG target once in case of PCARSE recurrence.
Sample Size: 30 subjects randomized in a 1:1 ratio to either burst suppression or seizure suppression EEG targets.
Primary Endpoints: Safety and feasibility of seizure control using burst suppression or seizure suppression EEG targets for PCARSE treatment.
Secondary Endpoints: Seizure recurrence incidence, time to seizure recurrence, number and dose of anti-seizure medication and anesthetic needed for PCARSE control, Death or disability according to the Cerebral Performance Category at Discharge (30 days), and Death or disability according to the modified Rankin Scale at Discharge (30 days).
Risks: Participants receiving anesthetics for PCARSE treatment will be monitored for hypotension, propofol infusion syndrome, and hypertriglyceridemia. Patients with PCARSE are at high risk for death and prolonged hospital stays.
Interventions
- Drug Burst 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. - Drug Seizure 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.
Primary outcome measures
- Post-cardiac arrest refractory status epilepticus control [Time frame: 48 hours]
Secondary outcome measures (10)
- Seizure recurrence incidence and duration (burden) [Time frame: 24-48 hours]
- Neurological Function at Discharge (CPC: Cerebral Performance Category) [Time frame: 30 days]
- Neurological Function at Discharge (mRS: modified Ranking Scale) [Time frame: 30 days]
- Neurological Function 90 days (CPC: Cerebral Performance Category) [Time frame: 90 days]
- Neurological Function 90 days (mRS: modified Ranking Scale) [Time frame: 90 days]
- Neurological Function 180 days (mRS: modified Ranking Scale) [Time frame: 180 days]
- Neurological Function180 days (mRS: modified Ranking Scale) [Time frame: 180 days]
- PCARSE Treatment Intensity [Time frame: 24-48 hours]
- Seizure recurrence incidence and duration (burden) [Time frame: 24-48 hours]
- PCARSE Treatment Intensity [Time frame: 24-48 hours]
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Zuckerberg San Francisco General Hospital — San Francisco
Identifiers
NCT: NCT05851391 · 21-34336