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Cardiac Arrest | TELSTAR: Treatment of ELectroencephalographic STatus Epilepticus After Cardiopulmonary Resuscitation

Cardiac Arrest research study

What is the primary objective of this study?

The purpose of this study is to estimate the effect of medical treatment of electro-encephalographic status epilepticus on neurological outcome of patients with postanoxic encephalopathy after cardiac arrest.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Cardiac Arrest

Anoxic Encephalopathy

Status Epilepticus

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

Drug:Anti-epileptic drugsRecommendations for the treatment of status epilepticus are based on recent international guidelines for treatment of overt status epilepticus. The objective of treatment with AED is to suppress all epileptiform activity. There is no clear proof that induction of a burst-suppression pattern is of additional value and induction of burst suppression is therefore not obligate. If the electroencephalographic status epilepticus returns after tapering sedative treatment at 24 hours, the procedure will be repeated. If the status returns after 2 x 24 hours, it will be considered refractory. Decisions regarding limitation or withdrawal of treatment will be done in accordance with the Dutch guideline "postanoxic coma". Reasons for withdrawal of treatment will be documented.

Other:No anti-epileptic drugsThe 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". Reasons for withdrawal of treatment will be documented.

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

Anti-epileptic drugsStep 1. Lorazepam 4 mg iv (initial dosage) titrated up to a maximum of 12 mg/24 hours OR midazolam 10 mg (initial dosage) up to 60 mg/24 hours (in steps of 5 mg/5 minutes) PLUS Fenytoine bolus i.v. 15-20 mg/kg in 30 minutes, followed by 150 mg 2 dd 1, adapted based on serum levels. Step 2. Propofol infusion with a maximum 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.

No anti-epileptic drugsThe 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.

Study Status

Recruiting

Start Date: April 2014

Completed Date: September 2019

Phase: N/A

Type: Interventional

Design:

Primary Outcome: Neurological outcome

Secondary Outcome: Long term outcome

Study sponsors, principal investigator, and references

Principal Investigator: Jeannette Hofmeijer, MD PhD

Lead Sponsor: University of Twente

Collaborator: Rijnstate Hospital

More information:https://clinicaltrials.gov/show/NCT02056236

Ruijter BJ, van Putten MJ, Horn J, Blans MJ, Beishuizen A, van Rootselaar AF, Hofmeijer J; TELSTAR study group. Treatment of electroencephalographic status epilepticus after cardiopulmonary resuscitation (TELSTAR): study protocol for a randomized controlled trial. Trials. 2014 Nov 6;15:433. doi: 10.1186/1745-6215-15-433.

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