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
The enrolment period has ended and data are being analyzed. Between May 2014 and Januari 2022, 172 patients have been enrolled.
We expect the first study results to be published in February 2022.
Trial registration
Clinicaltrials.gov, identifier NCT02056236.