HYPERION
Trial question
What is the role of moderate therapeutic hypothermia in patients with cardiac arrest who have non-shockable rhythm?
Study design
Multi-center
Open label
RCT
Population
Characteristics of study participants
36.0% female
64.0% male
N = 581
581 patients (208 female, 373 male).
Inclusion criteria: patients with coma who had been admitted to the ICU after resuscitation from cardiac arrest with non-shockable rhythm.
Key exclusion criteria: a no-flow time of > 10 minutes; a low-flow time of > 60 minutes; major hemodynamic instability; time from cardiac arrest to a screening of > 300 minutes; moribund condition; severe hepatic dysfunction.
Interventions
N=284 hypothermia (induction of a body temperature of 33°C with a window of +- 0.5 degree Celsius and maintained for 24 hours).
N=297 normothermia (body temperature maintained at 36.5 to 37.5°C for 48 hours according to the standard protocol).
Primary outcome
Rate of survival with a favorable neurologic outcome, Cerebral Performance Category of 1 or 2, on day 90
10.2%
5.7%
10.2 %
7.6 %
5.1 %
2.5 %
0.0 %
Hypothermia
Normothermia
Significant
increase ▲
NNT = 22
Significant increase in the rate of survival with a favorable neurologic outcome, Cerebral Performance Category of 1 or 2, on day 90 (10.2% vs. 5.7%; AD 4.5%, 95% CI 0.1 to 8.9).
Secondary outcomes
No significant difference in death at day 90 (81.3% vs. 83.2%; ARD -1.9, 95% CI -8 to 4.3).
No significant difference in survival to ICU discharge (21.8% vs. 20.5%; HR 1.07, 95% CI 0.75 to 1.52).
No significant difference in survival to hospital discharge (19.7% vs. 16.8%; HR 1.19, 95% CI 0.81 to 1.74).
Safety outcomes
No significant difference in prespecified serious adverse events.
Conclusion
In patients with coma who had been admitted to the ICU after resuscitation from cardiac arrest with non-shockable rhythm, hypothermia was superior to normothermia with respect to the rate of survival with a favorable neurologic outcome, Cerebral Performance Category of 1 or 2, on day 90.
Reference
Jean-Baptiste Lascarrou, Hamid Merdji, Amélie Le Gouge et al. Targeted Temperature Management for Cardiac Arrest with Nonshockable Rhythm. N Engl J Med. 2019 Dec 12;381(24):2327-2337.
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