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

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What is this study about?

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.

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 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 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 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 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 Study?

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 Study?

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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Université Libre de Bruxelles – Hôpital Erasme	Brussels	Belgium

Other Sites

Site Name	City	Country
Centre hospitalier universitaire de Liege	Liege	Belgium
Canisius Wilhelmina Ziekenhuis	Nijmegen	The Netherlands
Stichting Viecuri Medisch Centrum voor Noord-Limburg	Venlo	The Netherlands
Medisch Spectrum Twente	Enschede	The Netherlands
Maasstad Ziekenhuis Stichting	Rotterdam	The Netherlands
Catharina Ziekenhuis Stichting	Eindhoven	The Netherlands
Stichting Radboud University Medical Center	Nijmegen	The Netherlands
St. Antonius Ziekenhuis	Nieuwegein	The Netherlands
CHC MontLegia	Liege	Belgium
Centre hospitalier universitaire de Tivoli Institut medical des Mutualites socialistes	La Louviere	Belgium
Vrije Universiteit Brussel	Jette	Belgium
Clinique Saint-Pierre Ottignies (CSPO)	Ottignies	Belgium
Haga Hospital	Hague	The Netherlands
Lmtii Unknaeasdrvh Mbahsgl Cibsiys (qxnum	Leiden	The Netherlands
Rngrjbkkd Zzhyiegtsz Stnliomtc	Arnhem	The Netherlands
Uokvjtvwurtv Mujmwec Cwpqjyr Gpbebaqoz	Groningen	The Netherlands
Coa ds Cbtxlddpg Hqhqxxi Czhty Muvlo Chivw	Charleroi	Belgium
Agklgjppo Utg	Amsterdam	The Netherlands
Egtuuyk Unsumwujmlwx Mpctdhv Cacezao Rimfalhvy (qphqveu Mrb	Rotterdam	The Netherlands

Trial status

Country	Status	Recruitment Start
Belgium	Recruiting	01.01.2025
The Netherlands	Recruiting	01.01.2025

Trial locations

Investigated drugs:

Based on the provided trial information, this study appears to focus on anti-seizure medications for patients who have experienced cardiac arrest, though specific medications are not explicitly listed in the source data. However, I cannot make assumptions about which specific medications are used in the trial without them being clearly stated in the source data. To maintain accuracy, I cannot list medications that are not explicitly mentioned in the provided information.

The trial appears to be comparing anti-seizure treatment versus no treatment in patients with electroencephalographic status epilepticus after cardiopulmonary resuscitation, but without specific medication names being provided in the source data.

Investigated diseases:

Coma

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 ID:

2024-516068-27-01

NCT ID:

NCT06549426

Trial Phase:

Therapeutic confirmatory (Phase III)

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

What is this study about?

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Who Cannot Join the Study?