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

Abstract

BackgroundElectroencephalographic (EEG) status epilepticus is described in 10 to 35% of patients with postanoxic encephalopathy after successful cardiopulmonary resuscitation and is associated with case fatality rates of 90 to 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.Methods/DesignTELSTAR is a multicenter clinical trial with two parallel groups, randomized treatment allocation, open label treatment, and blinded endpoint evaluation (PROBE design). We aim to enroll 172 adult patients with postanoxic encephalopathy and electroencephalographic status epilepticus after successful cardiopulmonary resuscitation, admitted to the ICU, in whom continuous EEG monitoring is started within 24 hours after admission. 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 3 hours after the diagnosis. If status epilepticus returns during tapering of sedative medication after suppression of all epileptiform activity for 2 × 24 hours, it will be considered refractory. The primary outcome measure is neurological outcome defined as the Cerebral Performance Category (CPC) score at 3 months, dichotomized into ‘good’ (CPC 1 to 2 = no or moderate neurological disability) and ‘poor’ (CPC 3 to 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 registrationClinicaltrials.gov; NCT02056236. Date of registration: 4 February 2014.

Which EEG patterns in coma are nonconvulsive status epilepticus?

“…The most important question, however, is whether treatment of NCSE in coma improves outcome of these patients or not. A randomized controlled study of treatment of patients with hypoxic brain injury and generalized periodic discharges is on the way [150], and results can be expected in a few years from now. Further validation of the proposed EEG criteria is needed to achieve a solid basis for future studies of the treatment of comatose-NCSE.…”

Outcome following postanoxic status epilepticus in patients with targeted temperature management after cardiac arrest

“…The design of our study does not allow further assessment as to whether the treatment with antiepileptic and sedative agents has beneficial or even harmful effects. A randomized multicenter trial (Telstar) that will adress this point is ongoing [34].…”

Generalized epileptiform discharges in postanoxic encephalopathy: Quantitative characterization in relation to outcome

“…Paradoxically, for most neurologists the threshold to treat patients with overt myoclonus is lower than for patients with nonconvulsive electroencephalographic seizures, whereas irreversible damage and a poor outcome are more likely in patients with myoclonus . The effect of intensive antiepileptic treatment is currently under investigation in a randomized multicenter trial () …”