Dual therapy for severe seizures after cardiac arrest

SUPER-refractory Status Epilepticus After Cardiac Arrest: a Multicenter, Retrospective, Cohort Study of Dual Anti-glutamate Therapy With Ketamine and Perampanel

This study is testing a combination of two medications, ketamine and perampanel, to see if they can help people who have severe seizures after a cardiac arrest.

Quick facts

• Study type: Observational
• Enrollment: 80 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Milano Bicocca (other)
• Locations: 10 sites (Brescia, BS and 9 other locations)
• Trial ID: NCT05756621 on ClinicalTrials.gov

What this trial studies

This observational study investigates the effectiveness of a dual anti-glutamate therapy using ketamine and perampanel in patients experiencing super-refractory status epilepticus following cardiac arrest. The study aims to identify the best combination of antiseizure medications and anesthetics to improve outcomes in this challenging condition. Patients will be monitored using continuous electroencephalographic (cEEG) monitoring to assess their response to treatment and to evaluate prognostic indicators. The goal is to provide a more effective treatment strategy for patients who are often unresponsive to standard therapies.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older who are in a coma after cardiac arrest and diagnosed with super-refractory status epilepticus.

Not a fit: Patients whose status epilepticus has resolved after the first cycle of treatment or those with specific EEG patterns may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could significantly improve functional outcomes for patients suffering from severe seizures after cardiac arrest.

How similar studies have performed: While previous studies have explored treatment for status epilepticus, this specific combination therapy approach is novel and has not been extensively tested.

Eligibility criteria

Inclusion Criteria:

* age ≥ 18 years
* patients in coma after cardio-circulatory arrest (CCA) admitted to the Intensive Care Unit and treated with target temperature management (TTM) for the first 24 hours
* initiation of continuous electroencephalographic (cEEG) monitoring within 24-36 hours of CCA
* diagnosis of super-refractory status epilepticus, relapsed after the first cycle of anesthetics (lasting \> 24 hours) and antiepileptic therapy, defined according to the international Salzburg criteria9
* presence of pupillary reflex present bilaterally
* presence of N20 cortical response present bilaterally

Exclusion Criteria:

* EEG with periodic pattern (generalized periodic discharges; GPDs)
* status epilepticus resolved after the first cycle of anesthetics + antiepileptics
* pregnant women

Where this trial is running

Brescia, BS and 9 other locations

• ASST Spedali Civili Brescia — Brescia, BS, Italy (RECRUITING)
• Ospedale Centrale di Bolzano — Bolzano, BZ, Italy (NOT_YET_RECRUITING)
• Ospedale G. Brotzu — Cagliari, CA, Italy (NOT_YET_RECRUITING)
• Ospedale M. Bufalini — Cesena, FC, Italy (NOT_YET_RECRUITING)
• AOU Careggi — Florence, FI, Italy (NOT_YET_RECRUITING)
• Fondazione IRCCS San Gerardo dei Tintori Monza — Monza, MB, Italy (RECRUITING)
• Azienda Ospedaliero-Universitaria di Modena — Modena, MO, Italy (NOT_YET_RECRUITING)
• Azienda Ospedaliero-Universitaria di Parma — Parma, PR, Italy (NOT_YET_RECRUITING)
• Ospedale Santa Chiara Trento — Trento, TN, Italy (RECRUITING)
• Azienda Ospedaliero-Universitaria Integrata di Verona — Verona, VR, Italy (NOT_YET_RECRUITING)

Study contacts

• Principal investigator: Simone Beretta, MD, PhD — University of Milano Bicocca
• Study coordinator: Simone Beretta, MD, PhD

Conditions: Status Epilepticus, Cardiac Arrest, super-refractory, prognostic indicators, perampanel, ketamine