TELSTAR: Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation (TELSTAR)
Cardiac Arrest, Anoxic Encephalopathy, Status Epilepticus
About this trial
This is an interventional treatment trial for Cardiac Arrest focused on measuring Cardiac arrest, Postanoxic encephalopathy, Electroencephalographic status epilepticus, EEG monitoring, Anti-epileptic drugs
Eligibility Criteria
Inclusion Criteria:
- Patients after cardiac arrest with suspected postanoxic encephalopathy
- Age 18 years or older
- Continuous EEG with at least eight electrodes started within 24 hours after cardiac arrest
- Electroencephalographic status epilepticus on continuous EEG
- Possibility to start treatment within three hours after detection of electroencephalographic status epilepticus.
Exclusion Criteria:
- A known history of another medical condition with limited life expectancy (<6 months)
- Any progressive brain illness, such as a brain tumor or neurodegenerative disease
- Pre-admission Glasgow Outcome Scale score of 3 or lower
- Reason other than neurological condition to withdraw treatment
- Follow-up impossible due to logistic reasons
Sites / Locations
- Hôpital Erasme - Université libre de Bruxelles
- Radboud University Medical Center
- Medisch Spectrum Twente
- University Medical Center Groningen
- St. Antonius Hospital
- Academic Medical Center
- VieCuri Medical Centre
- Rijnstate Hospital
- Maasstad Hospital
- Maastricht UMC+
- Canisius-Wilhelmina Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Anti-epileptic drugs
No anti-epileptic drugs
Step 1: Phenytoin (loading dose 15-20 mg/kg iv, maintenance doses 150 mg iv twice per day) PLUS one of the following benzodiazepines (bolus + continuous infusion): lorazepam or midazolam. Benzodiazepine dosing regimes should be based on national and local protocols for status epilepticus treatment Step 2: Propofol infusion (with a maximum rate of 8 mg/kg/hour) PLUS a second anti-epileptic drug in addition to fenytoin: Option 1: levetiracetam bolus 1500 mg, followed by 1000 mg 2 dd 1 intravenously or Option 2: valproic acid bolus 10-20 mg/kg in 30 min, followed by15 mg/kg/day in 2 dosages intravenously. Step 3: Thiopental, initial dosage 12,5 mg/kg/hr for the first 6 hours followed by 5 mg/kg/hr for 6 hours. After these loading dosages, treatment should be guided by the EEG pattern.
The non-intervention group will be treated conform standard guidelines of treatment of comatose patients after cardiac arrest, but without anti-epileptic drugs or EEG based deep sedation. Treatment to suppress clinical myoclonia or seizures with low dose propofol is left to the discretion of the treating physician. Decisions regarding limitation or withdrawal of treatment will be done in accordance with the Dutch guideline "postanoxic coma" in both treatment arms. Reasons for withdrawal of treatment will be documented.