Dual Anti-glutamate Therapy in Super-refractory Status Epilepticus After Cardiac Arrest

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorUniversity of Milano Bicocca

About this trial

Status epilepticus (SE) is found in 20-30% of patients in coma after cardiac arrest, is often refractory to medical therapy and is considered a negative prognostic factor. Intensity and duration of treatment of refractory and super-refractory post-anoxic SE pose the ethical dilemma between futility of treatments and, conversely, their premature suspension. A recent study by the Epilepsy Center of the San Gerardo Hospital has shown that patients with super-refractory post-anoxic SE and favorable prognostic indicators can achieve a good functional outcome in more than 40% of cases, if treated with intensive and protracted therapy.

However, there is profound uncertainty about the best combination of antiseizure medications and anesthetics to use in this condition. A combined anti-glutamatergic therapy with ketamine (anti-NMDA receptor) and perampanel (anti-AMPA receptor), aimed at counteracting the excitotoxicity linked to global cerebral ischemia, could be particularly effective in the treatment of super-refractory SE with post-anoxic etiology. Preliminary results in the first 26 patients treated in the Coordinating Center of the project indicate that this therapy appears safe and highly effective (80% SE resolution, 40% good neurological outcome).

The aim of the SUPER-CAT study is to investigate the efficacy and safety of combined therapy with ketamine and perampanel (dual anti-glutamatergic therapy) in patients with post-anoxic super-refractory status epilepticus, compared to other therapies, using a multi-centre, retrospective, cohort study design.

Eligibility criteria

Qualifiers

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

Disqualifiers

EEG with periodic pattern (generalized periodic discharges; GPDs)

status epilepticus resolved after the first cycle of anesthetics + antiepileptics

pregnant women

Trial design

Treatments tested in this trial

  • Ketamine
  • Any anti-epileptic and anesthetic therapy, excluding Ketamine and Perampanel

Treatment groups

80 Participants
are divided into 2 treatment groups

Sponsors and collaborators

University of Milano Bicocca

Lead sponsor

Azienda Ospedaliera San Gerardo di Monza

Collaborator

Azienda Ospedaliero-Universitaria di Modena

Collaborator

Azienda Ospedaliera Universitaria Integrata Verona

Collaborator

Ospedale Centrale Bolzano

Collaborator

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia

Collaborator

Azienda Ospedaliero-Universitaria Careggi

Collaborator

Azienda Ospedaliero-Universitaria di Parma

Collaborator

Santa Chiara Hospital

Collaborator

Ospedale M. Bufalini Cesena

Collaborator

Azienda Ospedaliera Brotzu

Collaborator

Istituto Di Ricerche Farmacologiche Mario Negri

Collaborator