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Study of anti-seizure drug combination in comatose patients with status epilepticus after cardiac arrest

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients who experience status epilepticus (a severe form of continuous seizures) after cardiac arrest and cardiopulmonary resuscitation. The study aims to determine if treating seizures with medications improves recovery in unconscious patients who have survived cardiac arrest.

The study uses several anti-seizure medications administered through a vein, including diazepam, midazolam, lorazepam, propofol, esketamine, lacosamide, levetiracetam, and sodium valproate. These medications are given in a step-by-step approach to stop the seizure activity that is detected by brain wave monitoring.

The research will compare patients who receive seizure treatment with those who do not receive treatment. The main focus is on how well patients recover their ability to function in daily life six months after their cardiac arrest. The study will also look at the cost-effectiveness of the treatment approach.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    After cardiac arrest and resuscitation, your condition will be evaluated. You must be in a comatose state with a Glasgow Coma Scale score of 8 or lower.

    An EEG (brain wave monitoring) will be started within 24 hours after your heart has resumed beating.

  2. Step 2

    Group assignment

    If the EEG shows signs of status epilepticus (continuous seizure activity in the brain), you will be randomly assigned to either receive anti-seizure treatment or no anti-seizure treatment.

  3. Step 3

    Treatment protocol

    If assigned to the treatment group, you will receive medications through an intravenous line (directly into your bloodstream).

    The medications may include: diazepam, midazolam, lorazepam, sodium valproate, propofol, esketamine, lacosamide, and levetiracetam.

    Treatment will begin within three hours after detecting seizure activity on the EEG.

  4. Step 4

    Monitoring period

    Your brain activity will be continuously monitored using EEG throughout your hospital stay.

    Your overall medical condition will be closely monitored by the medical team.

  5. Step 5

    Follow-up assessment

    Six months after the cardiac arrest, your recovery will be evaluated using the extended Glasgow Outcome Scale.

    This evaluation will be conducted through a telephone interview by an independent investigator.

    The assessment will measure your level of recovery and functional ability.

Who can join the trial?

5 criteria

  • You must be at least 18 years old
  • You must be in a state of coma (a deep state of unconsciousness with a Glasgow Coma Scale score of 8 or lower) following a cardiac arrest that occurred outside the hospital
  • You must have undergone continuous brain wave monitoring (EEG) with at least 8 electrodes, started within 24 hours after your heart started beating again
  • You must have been diagnosed with ESE (Evolving Status Epilepticus - a severe form of continuous seizure activity) or possible ESE according to specific medical criteria
  • Your treatment must be able to begin within 3 hours after ESE is detected

Who cannot join the trial?

12 criteria

  • Patients younger than 18 years old cannot participate in the study
  • Patients with a known terminal illness (a disease that cannot be cured and is likely to cause death)
  • Patients with pre-existing brain damage that severely affects their daily functioning
  • Patients who have had previous cardiac arrests (when the heart stops beating)
  • Patients with a known allergy to any of the study medications
  • Pregnant or breastfeeding women
  • Patients who are already taking anti-seizure medications (drugs that prevent seizures)
  • Patients who cannot provide informed consent (either themselves or through a legal representative)
  • Patients who are currently participating in other clinical trials
  • Patients with severe liver or kidney dysfunction (organs not working properly)
  • Patients who have had neurosurgery (brain surgery) in the past 30 days
  • Patients with a history of drug-resistant epilepsy (seizures that don't respond well to medication)
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Investigated drugs

  • Midazolam

    is a short‑acting medication that helps stop seizures quickly. In this study it is given through an IV line to calm the brain’s excessive electrical activity in patients who are unconscious after a heart attack.

  • Levetiracetam

    is an anti‑seizure drug that works by stabilising nerve activity. It is administered intravenously and is used as one of the steps to try to control ongoing seizures in the trial.

  • Esketamine

    is a medication that can reduce brain excitability and may help stop seizures. It is given by IV injection as part of the stepwise treatment plan for patients with continuous seizure activity.

  • Propofol

    is a sedative that also has strong anti‑seizure effects. In the trial it is delivered as an IV infusion to deeply sedate the patient and halt seizure activity when earlier medicines are not enough.

  • Diazepam

    is a benzodiazepine that quickly reduces seizure activity. It is given intravenously early in the treatment sequence to try to stop the seizures.

  • Lorazepam

    is another benzodiazepine used to calm the brain’s electrical storms. It is administered by IV injection as part of the protocol to suppress seizures.

What is already known about the treatment

  • Midazolam

    This medication is given as an intravenous infusion using a clear solution for injection. It is an approved and widely used benzodiazepine that helps calm patients and stop seizures. It works by increasing the activity of the brain chemical GABA at GABA‑A receptors, which reduces nerve firing. It is classified as a short‑acting benzodiazepine sedative‑anticonvulsant.

  • Levetiracetam

    Levetiracetam is administered through an intravenous infusion of a sterile solution. It is a modern anti‑seizure drug that is approved for many types of seizures and is well documented in medical literature. Its action comes from binding to a protein called SV2A on nerve cells, which lowers the release of excitatory signals. It belongs to the class of anticonvulsants known as pyrrolidine derivatives.

  • Esketamine

    Esketamine is delivered by a single intravenous injection of a sterile solution. It is an approved anesthetic and pain reliever that is also studied for its rapid‑acting antidepressant effects. It blocks the NMDA type of glutamate receptors, decreasing excessive brain activity. It is classified as a dissociative anesthetic.

  • Propofol

    Propofol is given as an intravenous emulsion for injection or continuous infusion. It is a well‑established general anesthetic that is also used to control seizures in emergency settings. It enhances GABA‑A receptor activity, leading to calm and reduced nerve firing. It belongs to the class of intravenous anesthetic agents.

  • Diazepam

    Diazepam is administered by intravenous injection of a clear solution. It is a long‑standing benzodiazepine approved for seizures, anxiety, and muscle spasms. It works by boosting GABA activity at GABA‑A receptors, which quiets the brain. It is classified as a benzodiazepine sedative‑anticonvulsant.

  • Lorazepam

    Lorazepam is given as an intravenous injection of a sterile solution. It is an approved benzodiazepine used for seizures, severe anxiety, and sedation before procedures. It enhances the effect of GABA at GABA‑A receptors, helping to calm nerve activity. It is categorized as a benzodiazepine anticonvulsant.

Investigated diseases

  • Cardiac Arrest

    A sudden loss of heart function where the heart stops pumping blood effectively through the body. It occurs when the heart's electrical system malfunctions, causing the heart to stop beating properly. The condition develops suddenly and without warning, leading to a loss of consciousness within seconds.

  • Status Epilepticus

    A condition characterized by prolonged or repeated seizures without recovery of consciousness between episodes. These seizures typically last longer than 5 minutes or occur close together without the person returning to normal in between. The condition can cause continuous muscle contractions and altered mental status.

  • Comatose State

    A state of deep unconsciousness in which a person cannot be awakened and shows no normal response to painful stimuli, light, or sound. During this state, the person cannot perform voluntary actions and is unaware of their surroundings. Basic life functions such as breathing and heart rate continue, but the person shows no signs of awareness.

  • Cardiopulmonary Arrest

    A condition where both the heart and breathing stop simultaneously. It results in the immediate cessation of blood flow to vital organs. Without the combined function of the heart and lungs, oxygen fails to reach the body's tissues. The condition requires immediate emergency response.

Trial detailsLast updated 21 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-516068-27-01Estimated enrolment150 patientsSponsorUniversiteit Twente

sourced from the EU Clinical Trials Register and site verification

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