Actively Recruiting

Age: 18Years +
All Genders
NCT05756621

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

Complete this quick 3-step screening to check your eligibility

1
2
3
+1

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

Loading map...

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

Not the Right Trial for You?

Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.

Already have an account? Log in here