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

Status: Recruiting
Location: See all (10) locations...
Intervention Type: Drug
Study Type: Observational
SUMMARY

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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Ospedale Centrale di Bolzano
NOT_YET_RECRUITING
Bolzano
ASST Spedali Civili Brescia
RECRUITING
Brescia
Ospedale G. Brotzu
NOT_YET_RECRUITING
Cagliari
Ospedale M. Bufalini
NOT_YET_RECRUITING
Cesena
AOU Careggi
NOT_YET_RECRUITING
Florence
Azienda Ospedaliero-Universitaria di Modena
NOT_YET_RECRUITING
Modena
Fondazione IRCCS San Gerardo dei Tintori Monza
RECRUITING
Monza
Azienda Ospedaliero-Universitaria di Parma
NOT_YET_RECRUITING
Parma
Ospedale Santa Chiara Trento
RECRUITING
Trento
Azienda Ospedaliero-Universitaria Integrata di Verona
NOT_YET_RECRUITING
Verona
Contact Information
Primary
Simone Beretta, MD, PhD
simone.beretta@unimib.it
00390392333568
Time Frame
Start Date: 2022-01-15
Estimated Completion Date: 2025-09-30
Participants
Target number of participants: 80
Treatments
Dual anti-glutamate therapy (DUAL)
Patients who received ketamine as a continuous i.v. for 3 days (induction dose 1.5-3 mg/kg, followed by maintenance dose 2-10 mg/kg/h; dose adjustment according to EEG target of ketamine pattern) + oral perampanel via nasogastric tube for 5 days (12 mg if weight \> 60 kg; 9 mg if weight 50-60 kg; 6 mg if weight \< 50 kg), followed by gradual dose reduction according to clinical evolution.
Control (OTHERS)
Patients who received any antiseizure and anesthetic therapy according to usual clinical practice, excluding the two anti-glutamate drugs ketamine and perampanel.
Sponsors
Collaborators: Azienda Ospedaliero-Universitaria Careggi, Istituto Di Ricerche Farmacologiche Mario Negri, Azienda Ospedaliera Universitaria Integrata Verona, Ospedale M. Bufalini Cesena, Ospedale Centrale Bolzano, Azienda Ospedaliera Brotzu, Azienda Ospedaliero-Universitaria di Modena, Azienda Ospedaliero-Universitaria di Parma, Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia, Santa Chiara Hospital, Azienda Ospedaliera San Gerardo di Monza
Leads: University of Milano Bicocca

This content was sourced from clinicaltrials.gov