Actively Recruiting
Dual Anti-glutamate Therapy in Super-refractory Status Epilepticus After Cardiac Arrest
Led by University of Milano Bicocca · Updated on 2025-07-29
80
Participants Needed
10
Research Sites
193 weeks
Total Duration
On this page
Sponsors
U
University of Milano Bicocca
Lead Sponsor
A
Azienda Ospedaliera San Gerardo di Monza
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Dual Anti-glutamate Therapy in Super-refractory Status Epilepticus After Cardiac Arrest
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 18 years or older
- Coma after cardio-circulatory arrest admitted to Intensive Care Unit and treated with target temperature management for the first 24 hours
- Continuous electroencephalographic monitoring started within 24-36 hours after cardio-circulatory arrest
- Diagnosed with super-refractory status epilepticus relapsed after first anesthetic and antiepileptic therapy lasting more than 24 hours, according to international Salzburg criteria
- Pupillary reflex present on both sides
- N20 cortical response present on both sides
You will not qualify if you...
- EEG showing generalized periodic discharges (periodic pattern)
- Status epilepticus resolved after first anesthetic and antiepileptic therapy cycle
- Pregnant women
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 10 locations
1
ASST Spedali Civili Brescia
Brescia, BS, Italy
Actively Recruiting
2
Ospedale Centrale di Bolzano
Bolzano, BZ, Italy
Not Yet Recruiting
3
Ospedale G. Brotzu
Cagliari, CA, Italy
Not Yet Recruiting
4
Ospedale M. Bufalini
Cesena, FC, Italy
Not Yet Recruiting
5
AOU Careggi
Florence, FI, Italy
Not Yet Recruiting
6
Fondazione IRCCS San Gerardo dei Tintori Monza
Monza, MB, Italy, 20900
Actively Recruiting
7
Azienda Ospedaliero-Universitaria di Modena
Modena, MO, Italy
Not Yet Recruiting
8
Azienda Ospedaliero-Universitaria di Parma
Parma, PR, Italy
Not Yet Recruiting
9
Ospedale Santa Chiara Trento
Trento, TN, Italy
Actively Recruiting
10
Azienda Ospedaliero-Universitaria Integrata di Verona
Verona, VR, Italy
Not Yet Recruiting
Research Team
S
Simone Beretta, MD, PhD
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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