- Design
- Pilot multicentre randomised clinical trial
- Population
- 35 intubated adults with heatstroke, 10 ICUs in China
- Primary outcome
- Feasibility; secondary safety and 28-day outcomes
- Effect
- Severe GI injury 52.9% vs 0%; arrhythmia 41.2% vs 11.1%; survival 82.4% vs 83.3%
This pilot trial in ten Chinese intensive care units randomised 35 intubated adults with heatstroke to rapid cooling to 35°C within two hours, held for 48 hours, or to controlled normothermia (36.5 to 37.5°C), cooling only above 38°C.
The trial showed a full trial is feasible. It also showed harm: severe gastrointestinal injury occurred in 52.9% with hypothermia against 0% with normothermia, and arrhythmias in 41.2% against 11.1%. Every patient in the hypothermia group needed a sedative mixture for refractory shivering, against 27.8% with normothermia. There was no difference in 28-day survival (82.4% vs 83.3%) or poor functional outcome.
It does not question rapid initial cooling of heatstroke, which remains standard. It questions continuing to cool below normal temperature once a patient reaches intensive care.
- Cool heatstroke rapidly at presentation; that remains standard care.
- Once in intensive care, aim for normothermia rather than prolonged cooling to 35°C.
- Watch for gastrointestinal injury and arrhythmia in any patient cooled below normal temperature.
- Have a stepwise shivering protocol ready whenever targeted temperature management is used.
Why it matters
Heatstroke is rising, and protocols borrowed from cardiac arrest cooling may do harm here.
Don't overread it
A small pilot; it signals harm but cannot settle the question of benefit.
The statistics, in plain English
With 35 patients, the trial was too small to detect differences in survival. The harms reached statistical significance despite the small size, which makes them harder to dismiss.
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