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

RECRUITING

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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.

Conditions:

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

🗓️ Study Start (Actual) 7 August 2023

🗓️ Primary Completion (Estimated) 30 November 2024

✅ Study Completion (Estimated) 30 April 2025

👥 Enrollment (Estimated) 30

🔬 Study Type INTERVENTIONAL

📊 Phase PHASE2

Locations:

📍 San Francisco, California, United States

📋 Eligibility Criteria

Description

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

Ages Eligible for Study: 18 Years to N/A (ADULT, OLDER_ADULT)

Sexes Eligible for Study: ALL

Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

First Submitted 24 February 2023
First Submitted that Met QC Criteria 1 May 2023
First Posted 9 May 2023

Study Record Updates

Last Update Submitted that Met QC Criteria 17 June 2024
Last Update Posted 18 June 2024
Last Verified June 2024