VIGABatrin in Post-anoxic STATus Epilepticus - Phase IIa

University of Florida6 enrolled

Overview

This is a pilot trial of a single loading dose of vigabatrin in post-anoxic status epilepticus.

This pilot trial aims to demonstrate the feasibility of enteral administration of a single load of vigabatrin within targeted 48 hours of post-anoxic status epilepticus onset in unconscious survivors of cardiac arrest undergoing targeted temperature management. The load of VGB is in addition to the load of a commonly used intravenous second-line therapy given at the discretion of the treating neurologist. Serial blood tests will be obtained, including vigabatrin levels, taurine levels, neuron specific enolase, light chain neurofilament, and glial fibrillary acidic protein. In survivors that regain consciousness and survive to follow up, 6 months visual field perimetry will be obtained.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Status Epilepticus, Electrographic Coma

Interventions

Vigabatrin Only ProductDRUG

enteral medication administration, serial blood draws, and outcome assessment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

Inclusion Criteria: * age ≥ 18 years * non-traumatic cardiac arrest (regardless of non-perfusing rhythm, etiology, or location of arrest) in whom the decision to treat unequivocal electrographic status epilepticus (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 * requiring anesthetic infusion for any reason * have reliable arterial access for frequent blood sampling * established enteral access within 48h of post-anoxic status epilepticus onset. Exclusion Criteria: * prior history of generalized epilepsy * history of gastrointestinal surgery within the last 21 days * pregnancy * status epilepticus onset preceding initiation of electroencephalography monitoring

Locations (1)

University of Florida

Gainesville, Florida, United States

Outcomes

Primary Outcomes

Primary Pharmacologic Outcome - Absorption

By analyzing serial vigabatrin levels including baseline, we characterized vigabatrin absorption; the target was to achieve a detectable vigabatrin level in the serum of ≥ 80% of enrolled subjects by 3 hours post-load.

Time frame: 3h

Primary Feasibility Outcome - Enrollment and Drug Delivery

We looked at the ability to deliver vigabatrin within 48 hours of PASE onset in ≥ 80% of enrolled subjects. Vigabatrin dose was adjusted according to renal functioning (CrCl\>50 ml/min: 4500 mg, CrCl 30-50 ml/min: 2250 mg, CrCl\<30 ml/min: 1125 mg)

Time frame: 48 hours

Primary Feasibility Outcome - Visual Screening (Goldmann Perimetry)

We planned to obtain Goldmann perimetry testing in the subjects who could cooperate at the 6 months follow-up. Our goal was to have reliable visual field perimetry in ≥ 80% of survivors who regained consciousness following index hospitalization.

Time frame: 6 months

Primary Feasibility Outcome - Participants With Visual Screening for Taurine Levels

We obtained serial taurine levels during ICU stay at time 0h, 72h and 168h following vigabatrin administration. Our goal was to achieve a 90% completion rate for taurine levels.

Time frame: 0h, 72h and 168h following vigabatrin administration

Secondary Outcomes

Ultra-early Vigabatrin Administration

We tracked the proportion of enrolled subjects who received a vigabatrin load within 12 and 24 hours of PASE onset to explore the possibility of ultra-early administration of vigabatrin in subsequent phases.

Time frame: 0h to 48h after vigabatrin admnistration

Secondary Pharmacologic Outcome: Elimination

Data from ClinicalTrials.gov

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