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Search / Trial NCT05756621

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

Launched by UNIVERSITY OF MILANO BICOCCA · Mar 1, 2023

Trial Information

Current as of June 26, 2025

Recruiting

Keywords

Super Refractory Prognostic Indicators Perampanel Ketamine

ClinConnect Summary

The SUPER-CAT study is exploring a new treatment approach for patients who experience a severe form of seizures called super-refractory status epilepticus after a cardiac arrest. This condition is challenging to treat and can lead to poor outcomes, but recent findings suggest that certain patients may benefit from a combination of two medications: ketamine and perampanel. The goal of this trial is to see how effective and safe this dual therapy is compared to other treatments.

To participate in the study, patients must be at least 18 years old, in a coma after a cardiac arrest, and undergoing specific monitoring for their brain activity. They should also have a certain type of seizure that hasn't improved after initial treatments. If eligible, participants will receive the new treatment while being closely monitored by medical professionals. The study aims to provide valuable insights that could improve care for patients in similar situations in the future.

Gender

ALL

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

About University Of Milano Bicocca

The University of Milano-Bicocca is a distinguished academic institution renowned for its commitment to advancing research and education in the biomedical sciences. With a strong emphasis on interdisciplinary collaboration, the university fosters innovative clinical trials that aim to enhance patient care and medical outcomes. Its research initiatives are supported by state-of-the-art facilities and a dedicated team of experts, positioning the University of Milano-Bicocca as a leading sponsor in the realm of clinical trials, dedicated to translating scientific discoveries into practical applications for the benefit of society.

Locations

Parma, Pr, Italy

Firenze, Fi, Italy

Brescia, Bs, Italy

Bolzano, Bz, Italy

Monza, Mb, Italy

Modena, Mo, Italy

Trento, Tn, Italy

Verona, Vr, Italy

Cagliari, Ca, Italy

Cesena, Fc, Italy

Patients applied

0 patients applied

Trial Officials

Simone Beretta, MD, PhD

Principal Investigator

University of Milano Bicocca

Matteo Pozzi, MD

Study Chair

Fondazione IRCCS Gerardo dei Tintori Monza

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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