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

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ClinicalTrials.gov Identifier: NCT05851391
Recruitment Status : Recruiting
First Posted : May 9, 2023
Last Update Posted : August 14, 2023
Sponsor:
Collaborator:
The ZOLL Foundation
Information provided by (Responsible Party):
University of California, San Francisco

Study Description
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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.

Condition or disease Intervention/treatment Phase
Hypoxia-Ischemia, Brain Heart Arrest Status Epilepticus Refractory Status Epilepticus Seizures Anoxic-Ischemic Encephalopathy Anoxia-Ischemia, Cerebral Drug: Burst Suppression EEG Target Intravenous Anesthesia Drug: Seizure Suppression EEG Target Intravenous Anesthesia Phase 2

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.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest (RESTORE)
Actual Study Start Date : August 7, 2023
Estimated Primary Completion Date : November 30, 2024
Estimated Study Completion Date : April 30, 2025

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Burst Suppression EEG Target
Anesthetic will be titrated to achieve burst suppression on continuous EEG (50-99% attenuation/suppression) for 24 hours.
 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.
Seizure Suppression EEG Target
Anesthetic will be titrated to achieve seizure suppression on continuous EEG for 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.


Outcome Measures
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Primary Outcome Measures :
  1. Post-cardiac arrest refractory status epilepticus control [ Time Frame: 48 hours ]
    Continuous EEG will be monitored to determine time to PCARSE recurrence during the anesthetic maintenance and anesthetic weaning phase (combined)


Secondary Outcome Measures :
  1. Seizure recurrence incidence and duration (burden) [ Time Frame: 24-48 hours ]
    Presence of seizures on EEG after initiation of anesthetic maintenance phase

  2. Neurological Function at Discharge (CPC: Cerebral Performance Category) [ Time Frame: 30 days ]
    Cerebral Performance Category score at Discharge

  3. Neurological Function at Discharge (mRS: modified Ranking Scale) [ Time Frame: 30 days ]
    modified Rankin Scale score at Discharge

  4. Neurological Function 90 days (CPC: Cerebral Performance Category) [ Time Frame: 90 days ]
    Cerebral Performance Category score at 90 days

  5. Neurological Function 90 days (mRS: modified Ranking Scale) [ Time Frame: 90 days ]
    modified Rankin Scale score at Discharge

  6. Neurological Function 180 days (mRS: modified Ranking Scale) [ Time Frame: 180 days ]
    modified Rankin Scale score at Discharge

  7. Neurological Function180 days (mRS: modified Ranking Scale) [ Time Frame: 180 days ]
    modified Rankin Scale score at Discharge

  8. PCARSE Treatment Intensity [ Time Frame: 24-48 hours ]
    Number of anti-seizure medications and anesthetics used for PCARSE control after initiation of anesthetic maintenance phase and prior to weaning

  9. Seizure recurrence incidence and duration (burden) [ Time Frame: 24-48 hours ]
    Presence of seizures on EEG after initiation of anesthetic weaning phase

  10. PCARSE Treatment Intensity [ Time Frame: 24-48 hours ]
    Dose of anti-seizure medications and anesthetics used for PCARSE control after initiation of anesthetic maintenance phase and prior to weaning


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05851391


Contacts
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Contact: Edilberto Amorim, MD 628-206-3203 restorestudy@ucsf.edu
Contact: Dominica Randazzo (415)514-2120 restorestudy@ucsf.edu

Locations
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United States, California
Zuckerberg San Francisco General Hospital Recruiting
San Francisco, California, United States, 94110
Contact: Edilberto Amorim, MD         
Sponsors and Collaborators
University of California, San Francisco
The ZOLL Foundation
Investigators
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Principal Investigator: Edilberto Amorim, MD Assistant Professor of Neurology
More Information
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05851391    
Other Study ID Numbers: 21-34336
First Posted: May 9, 2023    Key Record Dates
Last Update Posted: August 14, 2023
Last Verified: August 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Seizures
Brain Diseases
Brain Ischemia
Status Epilepticus
Hypoxia-Ischemia, Brain
Heart Arrest
Ischemia
Hypoxia
Pathologic Processes
Heart Diseases
Cardiovascular Diseases
 Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms, Respiratory
Central Nervous System Diseases
Cerebrovascular Disorders
Vascular Diseases
Hypoxia, Brain
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs