Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at San Francisco, California
Dates
study started
completion around
Principal Investigator
by Edilberto Amorim, MD
Headshot of Edilberto Amorim
Edilberto Amorim

Description

Summary

Brain injury is the main cause of death and disability for patients surviving cardiac arrest resuscitation and seizures are diagnosed in up to a third of these patients. We are proposing a pilot randomized placebo-controlled clinical trial to evaluate the safety and feasibility of perampanel use for PCARSE prevention after cardiac arrest.

Details

More than 500,000 Americans have a cardiac arrest every year and 100,000 survive to hospital admission. Brain injury is the main cause of death and disability for patients surviving cardiac arrest resuscitation and seizures are diagnosed in up to a third of these patients. Seizures with or without muscle jerks, i.e. myoclonic seizures, are the most common seizure type after a cardiac arrest. Despite being common, seizures are usually refractory to treatment (post-cardiac arrest refractory status epilepticus) and the vast majority of patients with this diagnosis die. We are proposing a pilot randomized placebo-controlled clinical trial to evaluate the safety and feasibility of perampanel use for PCARSE prevention after cardiac arrest. Perampanel is a non-competitive AMPA glutamate receptor antagonist approved for adjunctive treatment of partial-onset seizures and primary generalized tonic-clonic seizures, however there are no randomized trials in critically ill cardiac arrest patients at risk for seizures. This medication has been used for the management of refractory status epilepticus, including status epilepticus post-cardiac arrest. We will randomize patients to placebo or perampanel after admission to the intensive care unit. The study's primary outcome will be the incidence of severe adverse events. Secondary efficacy and safety endpoints include incidence of seizures and PCARSE, seizure frequency, time to seizure control, number of anti-seizure medications necessary for seizure control, duration of treatment with anesthetics for seizure control, and time to coma awakening. This study will help determine the safety and feasibility of primary seizure prophylaxis after cardiac arrest.

Keywords

Heart Arrest, Seizure, Status Epilepticus, Seizures, Status Epilepticus, Heart Arrest, Perampanel

Eligibility

You can join if…

Open to people ages 18 years and up

Age ≥18 years old Non-traumatic, out-of-hospital cardiac arrest Comatose on admission - defined as not following commands Return of spontaneous circulation (ROSC) within less than 45 minutes from the time of cardiac arrest (defined as the time of 911 or EMS (emergency medical services) witnessed arrest) Admission to the intensive care unit at Zuckerberg San Francisco General Hospital

You CAN'T join if...

Acute cerebral hemorrhage or infarction Pregnancy Prisoner Severe kidney function impairment with creatinine clearance inferior to 30 ml/min Severe liver impairment with liver function tests five times above the upper limit of normal Electrographic or electroclinical seizures diagnosis using American Clinical Neurophysiology criteria confirmed by an epileptologist after cardiac arrest

Location

  • Zuckerberg San Francisco General Hospital
    San Francisco California 94110 United States

Lead Scientist at UCSF

  • Edilberto Amorim, MD
    Dr. Ed Amorim is a neurologist with subspecialty training in critical care and epilepsy who treats patients with stroke, traumatic brain injury, coma, epilepsy, sleep disorders, and other critical illnesses. He has expertise in neurological intensive care, telemedicine, and multimodal brain monitoring with EEG.

Details

Status
not yet accepting patients
Start Date
Completion Date
(estimated)
Sponsor
University of California, San Francisco
Links
Related Info
ID
NCT06401707
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 52 study participants
Last Updated