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

ConditionsHypoxia-Ischemia, BrainHeart ArrestStatus EpilepticusRefractory Status EpilepticusSeizuresAnoxic-Ischemic EncephalopathyAnoxia-Ischemia, Cerebral
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of California, San Francisco

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Acute cerebral hemorrhage or infarction

Pregnancy

Prisoners

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

30 Participants
are divided into 2 treatment groups
Group A: Burst Suppression EEG TargetOther 1 intervention
Group B: Seizure Suppression EEG TargetOther 1 intervention

Trial outcomes

Primary outcomes

1

Post-cardiac arrest refractory status epilepticus control

Continuous EEG will be monitored to determine time to PCARSE recurrence during the anesthetic maintenance and anesthetic weaning phase (combined)

Time frame
48 hours

Secondary outcomes

1

Seizure recurrence incidence and duration (burden)

Presence of seizures on EEG after initiation of anesthetic maintenance phase

Time frame
24-48 hours
2

Neurological Function at Discharge (CPC: Cerebral Performance Category)

Cerebral Performance Category score at Discharge

Time frame
30 days
3

Neurological Function at Discharge (mRS: modified Ranking Scale)

modified Rankin Scale score at Discharge

Time frame
30 days
4

Neurological Function 90 days (CPC: Cerebral Performance Category)

Cerebral Performance Category score at 90 days

Time frame
90 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of California, San Francisco

Lead sponsor

The ZOLL Foundation

Collaborator

Source ClinicalTrials.gov
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