RecruitingN/Aketamine

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

Sponsored by University of Milano Bicocca

NCT ID
NCT05756621
Target Enrollment
80 participants
Start Date
2022-01-15
Est. Completion
2025-09-30

About This Study

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 Studied

Status EpilepticusCardiac Arrest

Interventions

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

Eligibility

Age:18 Years - N/A
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* 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

Exclusion Criteria:

* EEG with periodic pattern (generalized periodic discharges; GPDs)
* status epilepticus resolved after the first cycle of anesthetics + antiepileptics
* pregnant women

Study Locations (10)

ASST Spedali Civili Brescia
Brescia, BS, Italy
Ospedale Centrale di Bolzano
Bolzano, BZ, Italy
Ospedale G. Brotzu
Cagliari, CA, Italy
Ospedale M. Bufalini
Cesena, FC, Italy
AOU Careggi
Florence, FI, Italy
Fondazione IRCCS San Gerardo dei Tintori Monza
Monza, MB, Italy
Azienda Ospedaliero-Universitaria di Modena
Modena, MO, Italy
Azienda Ospedaliero-Universitaria di Parma
Parma, PR, Italy
Ospedale Santa Chiara Trento
Trento, TN, Italy
Azienda Ospedaliero-Universitaria Integrata di Verona
Verona, VR, Italy

Interested in this trial?

Contact the study team to learn more about eligibility and enrollment.

Simone Beretta, MD, PhD
CONTACT
00390392333568simone.beretta@unimib.it
View on ClinicalTrials.gov
Data Source
ClinicalTrials.gov

Last updated from source