Actively Recruiting

Age: 18Years +
All Genders
ID05756621

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

Led by University of Milano Bicocca · Updated on 2025-07-29

80

Participants Needed

10

Research Sites

N/A

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) occurs in 20-30% of patients in coma after cardiac arrest and is often resistant to treatment, leading to poor outcomes. This study investigates the effectiveness and safety of a combined anti-glutamatergic therapy using ketamine and perampanel for treating super-refractory post-anoxic SE. The research aims to compare this dual therapy to other antiseizure and anesthetic treatments, addressing uncertainty about optimal care for this condition through a multicenter, retrospective cohort design. The study compares two groups: one receiving ketamine intravenously for 3 days with doses adjusted by EEG monitoring, combined with oral perampanel for 5 days via nasogastric tube, followed by gradual dose reduction; and a control group receiving standard antiseizure and anesthetic therapies excluding ketamine and perampanel. The research involves multiple Italian hospitals and focuses on patients with super-refractory status epilepticus after cardiac arrest, selected based on neurological prognostic indicators. Participants' care is observed retrospectively without intervention changes. Data collected include EEG patterns, neurological outcomes during Intensive Care Unit stays, and 6-month post-cardiac arrest results. Researchers measure status epilepticus resolution, neurological recovery, mortality, and safety indicators such as cholestasis and cardiac events. The study's findings will guide future treatment strategies and potential randomized trials.

CONDITIONS

Brief 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
  • In coma after cardio-circulatory arrest and admitted to Intensive Care Unit
  • Treated with target temperature management for first 24 hours
  • Continuous EEG monitoring started within 24 to 36 hours after cardiac arrest
  • Diagnosed with super-refractory status epilepticus relapsing after first anesthetic and antiepileptic therapy cycle lasting more than 24 hours
  • Bilateral pupillary reflex present
  • Bilateral N20 cortical response present
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

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Participants admitted to Intensive Care Unit after cardiac arrest are assessed with EEG and neurological exams to confirm super-refractory status epilepticus and eligibility criteria.

Treatment

Duration - Up to 5 days of medication administration with gradual dose reduction as clinically indicated

Participants receive either dual anti-glutamatergic therapy with ketamine intravenously for 3 days combined with oral perampanel for 5 days, or other antiseizure and anesthetic therapies according to usual clinical practice.

Continuous EEG monitoring and clinical assessments during ICU stay up to 30 days

Follow-up

Duration - 6 months

Participants are monitored for neurological outcomes and survival up to 6 months after cardiac arrest.

Follow-up assessments to evaluate neurological status and survival at 6 months

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

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Research Team

S

Simone Beretta, MD, PhD

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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Published Research Related To This Trial

The frequency and timing of epileptiform activity on continuous electroencephalogram in comatose post-cardiac arrest syndrome patients treated with therapeutic hypothermia.

Ram Mani, Sarah E Schmitt, Maryann Mazer...

https://pubmed.ncbi.nlm.nih.gov/22366352

Protocol-driven neurological prognostication and withdrawal of life-sustaining therapy after cardiac arrest and targeted temperature management.

Irina Dragancea, Matthew P Wise, Nawaf Al-Subaie...

https://pubmed.ncbi.nlm.nih.gov/28506865

European Resuscitation Council and European Society of Intensive Care Medicine Guidelines 2021: Post-resuscitation care.

Jerry P Nolan, Claudio Sandroni, Bernd W Böttiger...

https://pubmed.ncbi.nlm.nih.gov/33773827

Outcome following postanoxic status epilepticus in patients with targeted temperature management after cardiac arrest.

Irina Dragancea, Sofia Backman, Erik Westhall...

https://pubmed.ncbi.nlm.nih.gov/26117526

Efficacy and safety of perampanel oral loading in postanoxic super-refractory status epilepticus: A pilot study.

Simone Beretta, Giada Padovano, Andrea Stabile...

https://pubmed.ncbi.nlm.nih.gov/30159874