Abstract
Convulsive status epilepticus (CSE) is a major medical emergency associated with a 50 % morbidity rate. CSE guidelines have recommended prompt management for many years, but there is no evidence to date that they have significantly improved practices or outcomes. Developing neuroprotective strategies for use after CSE holds promise for diminishing morbidity and mortality rates. Hypothermia has been shown to afford neuroprotection in various health conditions. We therefore designed a trial to determine whether 90-day outcomes in mechanically ventilated patients with CSE requiring management in the intensive care unit (ICU) are improved by early therapeutic hypothermia (32–34 °C) for 24 h with propofol sedation. We are conducting a multicentre, open-label, parallel-group, randomised, controlled trial (HYBERNATUS) of potential neuroprotective effects of therapeutic hypothermia and routine propofol sedation started within 8 h after CSE onset in ICU patients requiring mechanical ventilation. Included patients are allocated to receive therapeutic hypothermia (32–34 °C) plus standard care or standard care alone. We plan to enrol 270 patients in 11 ICUs. An interim analysis is scheduled after the inclusion of 135 patients. The main study objective is to evaluate the effectiveness of therapeutic hypothermia (32–34 °C) for 24 h in diminishing 90-day morbidity and mortality (defined as a Glasgow Outcome Scale score <5). The HYBERNATUS trial is expected to a decreased proportion of patients with a Glasgow Outcome Scale score lower than 5 after CSE requiring ICU admission and mechanical ventilation.Trial registration Clinicaltrials.gov identifier NCT01359332 (registered on 23 May 2011)
Highlights
Convulsive status epilepticus (CSE) is a life-threatening emergency that requires on-scene antiepileptic treatment adjusted according to the treatment response [1]
Despite national and international guidelines emphasising the importance of urgent anticonvulsant therapy according to a stepwise algorithm, SE remains associated with high mortality and morbidity rates
The contrast between the dual anticonvulsant and neuroprotective properties of therapeutic hypothermia demonstrated in experimental studies, on the one hand, and the paucity of clinical evidence, on the other, combined with the potential beneficial effects of therapeutic hypothermia on several causes of SE, prompted us to design the HYBERNATUS trial [35]
Summary
Convulsive status epilepticus (CSE) is a life-threatening emergency that requires on-scene antiepileptic treatment adjusted according to the treatment response [1]. Legriel et al Ann. Intensive Care (2016) 6:54 seizures, focal neurological signs, and progression to refractory status epilepticus (SE) [4]. Intensive Care (2016) 6:54 seizures, focal neurological signs, and progression to refractory status epilepticus (SE) [4] Some of these factors may be amenable to improvement and may constitute therapeutic targets. Pathophysiological considerations and experimental data suggest a beneficial effect of therapeutic hypothermia in SE. Proof of such an effect in human patients has not been obtained [31, 32]. HYBERNATUS is a multicentre, open-label, parallel-group, randomised, controlled trial in patients with CSE requiring admission to the intensive care unit (ICU) and mechanical ventilation
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