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Intravenous Anesthesia

Burst Suppression Therapy for Seizures after Cardiac Arrest (RESTORE Trial)

Phase 2
Recruiting
Led By Edilberto Amorim, MD
Research Sponsored by University of California, San Francisco
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Non-traumatic, out-of-hospital cardiac arrest
Diagnosis of post-cardiac arrest refractory status epilepticus confirmed with continuous EEG monitoring within 7 days from ROSC
Must not have
Acute cerebral hemorrhage or infarction
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 24-48 hours
Awards & highlights
No Placebo-Only Group

Summary

This trial is studying if an electrical brain stimulation therapy is safe & helpful for people with life-threatening seizures after a heart attack.

Who is the study for?
This trial is for adults over 18 who've had a non-traumatic, out-of-hospital cardiac arrest and are now in a coma with refractory status epilepticus confirmed by EEG. They must have regained circulation within 45 minutes and be admitted to the ICU. It's not for those with acute brain bleeding or stroke, pregnant women, or prisoners.
What is being tested?
The RESTORE trial is comparing two types of intravenous anesthesia based on EEG targets: one aiming for burst suppression (reducing brain activity) and the other for seizure suppression (stopping seizures), to see which is safer and more feasible after cardiac arrest.
What are the potential side effects?
Potential side effects may include typical risks associated with general anesthesia such as respiratory depression, low blood pressure, allergic reactions, and potential impact on brain function due to changes in electrical activity monitored by EEG.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I had a sudden heart stoppage outside of a hospital without injury.
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I was diagnosed with a severe seizure condition after a heart attack, confirmed by EEG.
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I am 18 years old or older.
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I have been admitted to the intensive care unit.
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I was unable to follow commands upon hospital admission.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have had a recent stroke or brain bleed.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~24-48 hours
This trial's timeline: 3 weeks for screening, Varies for treatment, and 24-48 hours for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Post-cardiac arrest refractory status epilepticus control
Secondary study objectives
Neurological Function 180 days (mRS: modified Ranking Scale)
Neurological Function 90 days (CPC: Cerebral Performance Category)
Neurological Function 90 days (mRS: modified Ranking Scale)
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Seizure Suppression EEG TargetExperimental Treatment1 Intervention
Anesthetic will be titrated to achieve seizure suppression on continuous EEG for 24 hours.
Group II: Burst Suppression EEG TargetExperimental Treatment1 Intervention
Anesthetic will be titrated to achieve burst suppression on continuous EEG (50-99% attenuation/suppression) for 24 hours.

Find a Location

Who is running the clinical trial?

University of California, San FranciscoLead Sponsor
2,587 Previous Clinical Trials
14,901,146 Total Patients Enrolled
8 Trials studying Seizures
1,388 Patients Enrolled for Seizures
The ZOLL FoundationUNKNOWN
Edilberto Amorim, MDPrincipal InvestigatorAssistant Professor of Neurology
1 Previous Clinical Trials
52 Total Patients Enrolled
1 Trials studying Seizures
52 Patients Enrolled for Seizures

Media Library

Burst Suppression EEG Target Intravenous Anesthesia (Intravenous Anesthesia) Clinical Trial Eligibility Overview. Trial Name: NCT05851391 — Phase 2
Seizures Research Study Groups: Burst Suppression EEG Target, Seizure Suppression EEG Target
Seizures Clinical Trial 2023: Burst Suppression EEG Target Intravenous Anesthesia Highlights & Side Effects. Trial Name: NCT05851391 — Phase 2
Burst Suppression EEG Target Intravenous Anesthesia (Intravenous Anesthesia) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05851391 — Phase 2
~0 spots leftby Nov 2024
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