HYBERNATUS Trial

HYBERNATUS

  • Hypothermia for Brain Enhancement Recovery by Neuroprotective and Anticonvulsivant Action after Convulsive Status Epilepticus Trial
  • multicenter, open-label, parallel-group, RCT
  • 11 French ICUs
  • 03/2011 to 01/2015

 

Inclusion

  • >18
  • convulsive status epilepticus – >=5mins continuous clinical seizure activity or >2 sz without return to baseline in interval
  • admitted <8hours after onset
  • intubated

Exclusion

  • return to baseline state of consciousness
  • need for ‘E’ surgery that would preclude therapeutic hypothermia
  • post-anoxic status epilepticus
  • imminent death
  • DNR order
  • bacterial meningitis

Methodology

  • lower T to 32-34C x 24h
  • IV fluids at 4C, ice packs at groin and neck, cold-air tunnel around body
  • repeated propofol boluses if seizures continue followed by maintenance IV infusion to maintain burst-suppression EEG pattern x 24 hours
  • Outcomes assessed:
    • Primary: absence of functional impairment at 90d (GOS score of 5)
    • Secondary
      • death rates: ICU, hospital, day 90
      • progression to EEG-confirmed status epilepticus (coma +/- subtle convulsive movements but with generalized or lateralized ictal discharges on EEG between 6 and 12 hours after randomization
      • refractory status epilepticus on day 1 (continuous or intermittent clinical seizures, EEG-confirmed seizures, or both despite two AEDs within 24 hours after onset)
      • super-refractory status epilepticus (ongoing or recurrent status epilepticus between 24 and 48 hours after initiation of anesthetic treatment)
      • total seizure duration
      • ICU LOS
      • Hospital LOS

capture

Outcome:

  • 268 patients included in analysis, 138 in hypothermia group, 130 in control group
  • PRIMARY OUTCOME = GOS5 — 49% vs 43% (OR 1.22 95% CI 0.75-1.99 p=0.43)
  • 15 (hypothermia group) vs 29 patients had progression to EEG-confirmed status epilepticus (OR 0.40 95% CI 0.2-0.79, p=0.009)
  • no other secondary outcomes differed significantly

 

 

 

Conclusion:

  • no beneficial effect of therapeutic hypothermia vs standard care alone in patients with status epilepticus who are receiving mechanical ventilation.

Current Evidence for Therapeutic Hypothermia in Neurocritical Care:

  1. TBI- controversial
  2. refractory intracranial hypertension, ischemic stroke and ICH – incorporated into treatment
  3. Bacterial meningitis with coma – may be harmful 

 

Reference:

Legriel, Stephane et al. “Hypothermia For Neuroprotection In Convulsive Status Epilepticus”. New England Journal of Medicine 375.25 (2016): 2457-2467.

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