Ignite Creation Date:
2024-05-06 @ 6:58 PM
Last Modification Date:
2024-10-26 @ 2:58 PM
Study NCT ID:
NCT05851391
Status:
RECRUITING
Last Update Posted:
2024-06-18
First Post:
2023-02-24
Brief Title:
buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest
Sponsor:
University of California San Francisco
Organization:
University of California San Francisco
Study Overview
Official Title:
buRst-supprESsion TO Stop Refractory Status Epilepticus Post-cardiac Arrest RESTORE
Status:
RECRUITING
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
RESTORE
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
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 11 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
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 11 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None