Treatment of electroencephalographic status epilepticus after cardiopulmonary resuscitation (TELSTAR): study protocol for a randomized controlled trial

Background
Electroencephalographic (EEG) status epilepticus is described in 10-35% of patients with postanoxic encephalopathy after successful cardiopulmonary resuscitation and is associated with case fatality rates of 90-100%. It is unclear whether these EEG patterns represent a condition to be treated with anticonvulsants to improve outcome, or an expression of severe ischemic damage, in which treatment is futile.

Design
TELSTAR is a multicenter clinical trial with two parallel groups, randomized treatment allocation, open label treatment, and blinded endpoint evaluation (PROBE design).

Population
We aim to enroll 172 adult patients with postanoxic encephalopathy and electroencephalographic status epilepticus after successful cardiopulmonary resuscitation, admitted to the intensive care unit, in whom continuous EEG monitoring is started within 24 hours after admission.

Interventions
Patients are randomly assigned to either medical treatment to suppress all electrographic seizure activity, or no treatment of electroencephalographic status epilepticus. Antiepileptic treatment is based on guidelines for treatment of overt status epilepticus and is started within three hours after the diagnosis. If status epilepticus returns during tapering of sedative medication after suppression of all epileptiform activity for 2 x 24 hours, it will be considered refractory.

Outcome measures
The primary outcome measure is neurological outcome defined as the Cerebral Performance Category (CPC) score at three months, dichotomized into “good” (CPC 1-2 = no or moderate neurological disability) and “poor” (CPC 3-5 = severe disability, coma, or death). Secondary outcome measures include mortality and, for patients surviving up to 12 months, cognitive functioning, health related quality of life, and depression.

Trial status
Recruitment commenced in May 2014 and is ongoing. The expected time of completion is November 2018.

Trial registration
Clinicaltrials.gov, identifier NCT02056236.