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
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