Status Epilepticus – VIGAB-STAT

Name: VIGAB-STAT (A phase IIa feasibility trial of irreversible GABA-transaminase inhibition as adjunct treatment of status epilepticus after cardiac arrest)

Contact: Ralisa Pop (Lead CRC 352-273-5550 x45693) and Jessica Spana (Back-up CRC, 352-273-5554), Dr. Carolina Maciel (PI)

Enrolling hours: technically 24/7, still need to work out on call schedule.

Diagnosis: PASE/ CA

Inclusion:

  1. 18 – 80 years of age
  2. Non-traumatic CA (regardless of non-perfusing rhythm, etiology, or location of arrest) in whom the decision to treat unequivocal electrographic SE (as defined by the American Clinical Neurophysiology Society: having generalized spike/sharp-wave discharges ≥ 3Hz or any evolving pattern reaching > 4Hz, lasting ≥ 10 minutes, or comprising > 50% of any hour of recording) has been made.

    The inclusion criteria have been expanded to include presumed electroclinical status epilepticus defined in this study as ictal-interictal continuum patterns of at least 1Hz as long as patient is treated with an antiseizure medication per the decision of the clinical treatment team. The time of onset for PASE in this setting will be the time of the loading dose of antiseizure medication.

  3. Requiring anesthetic infusion for any reason
  4. Have reliable arterial access for frequent blood sampling
  5. Established enteral access within 48h of PASE onset
  6. Competent LAR

Exclusion:

  1. Prior history of generalized epilepsy
  2. History of gastrointestinal surgery within the last 21 days
  3. Pregnant women
  4. PASE onset preceding initiation of EEG monitoring