This mammoth effort was an open-label pragmatic RCT comparing hypothermia (33 degrees) vs normothermia (37 degrees) in comatose survivors of cardiac arrest with non-shockable rhythms (PEA or asystole).
As if PEA and asystole were not bad enough, they excluded the sicker patients who would have highly likely died anyway- regardless of cooling or no cooling. These were patients who had no CPR for >10 minutes, CPR for more than 60 minutes, those with high vasopressor requirements etc.
The primary outcome was a good one; survival with a favorable day-90 neurologic outcome. This was defined as independent & able to perform ADL’s (CPC score 1-2). Unfortunately, it was possibly poorly determined by a single blinded psychologist by phone interview.
Over 4 years, 581 patients were included from 25 French ICU’s. On day 90, 10.2% of the hypothermia group vs. 5.7% of the normothermia had a good outcome (difference 4.5% 95%CI 0.1 to 8.9; P=0.04 and a NNT of 22.) Overall mortality did not differ between the groups at 80%.
Despite the results, I am a bit less enthusiastic about this one.
The literature is still conflicting, and this is far from overwhelming data.
The primary result has a fragility index of 1. If only one of the patients that did well in the hypothermia group were reclassified as unfavorable at 90 days, the results would not have been statistically significant… we would be talking about a negative trial.
There are other issues with the measurement of the primary outcome, external validity and a few other things.
In the end, it is probably fine if your ICU wants to cool these patients. But please make sure it does not distract & get in the way of providing adequate resuscitation and supportive care. Stay cool (or not) and do the right things first.
Lascarrou JB, Merdji H, Le Gouge, A, et al. Targeted Temperature Management for Cardiac Arrest with Non-Shockable Rhythm. New Engl J Med; 2019: 381:2327-2337. [link to article]
Dr Brian Doyle is an emergency physician originally from the United States but now very much calls Tasmania his home. Unfortunately, it will now be a bit more difficult to deport him from the country as he passed his Australian citizenship test a few years ago. (He was able to answer that Phar Lap won the Melbourne rather than the Davis Cup). His main interests are mostly the clinical aspects of emergency medicine but also in education, ultrasound and critical appraisal of the literature. He spends much of his time annoying people to help out with conferences.