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

NCT05851391 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2025-05-15

No results posted yet for this study

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.

Conditions

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

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.

Sponsors & Collaborators

Principal Investigators

  • Edilberto Amorim, MD · Assistant Professor of Neurology

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-07
Primary Completion
2026-11-30
Completion
2027-04-30
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05851391 on ClinicalTrials.gov