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

Locations

10
ASST Spedali Civili Brescia BresciaBS, Italy
Ospedale Centrale di Bolzano BolzanoBZ, Italy
Ospedale G. Brotzu CagliariCA, Italy
Ospedale M. Bufalini CesenaFC, Italy

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