CAERvest® - a novel endothermic hypothermic device for core temperature cooling: safety and efficacy testing.

INTRODUCTION: Cooling of the body is used to treat hyperthermic individuals with heatstroke or to depress core temperature below normal for neuroprotection. A novel, chemically activated, unpowered cooling device, CAERvest®, was investigated for safety and efficacy. METHODS: Eight healthy male participants (body mass 79.9 ± 1.9 kg and body fat percentage 16.1 ± 3.8%) visited the laboratory (20 °C, 40% relative humidity) on four occasions. Following 30-min rest, physiological and perceptual measures were recorded. Participants were then fitted with the CAERvest® proof of concept (PoC) or prototype 1 (P1), 2 (P2) or 3 (P3) for 60 min. Temperature, cardiovascular and perceptual measures were recorded every 5 min. After cooling, the CAERvest® was removed and the torso checked for cold-related injuries. RESULTS: Temperature measures significantly (p < 0.05) reduced pre to post in all trials. Larger reductions in core and skin temperatures were observed for PoC (-0.36 ± 0.18 and -1.55 ± 0.97 °C) and P3 (-0.36 ± 0.22 and -2.47 ± 0.82 °C), compared with P1 and P2. No signs of cold-related injury were observed at any stage. CONCLUSION: This study demonstrates that the CAERvest® is an effective device for reducing body temperature in healthy normothermic individuals without presence of cold injury. Further research in healthy and clinical populations is warranted.

Final results of MRC CRASH, a randomised placebo-controlled trial of intravenous corticosteroid in adults with head injury-outcomes at 6 months.

MRC CRASH is a randomised controlled trial (ISRCTN74459797) of the effect of corticosteroids on death and disability after head injury. We randomly allocated 10,008 adults with head injury and a Glasgow Coma Scale score of 14 or less, within 8 h of injury, to a 48-h infusion of corticosteroid (methylprednisolone) or placebo. Data at 6 months were obtained for 9673 (96.7%) patients. The risk of death was higher in the corticosteroid group than in the placebo group (1248 [25.7%] vs 1075 [22.3%] deaths; relative risk 1.15, 95% CI 1.07-1.24; p=0.0001), as was the risk of death or severe disability (1828 [38.1%] vs 1728 [36.3%] dead or severely disabled; 1.05, 0.99-1.10; p=0.079). There was no evidence that the effect of corticosteroids differed by injury severity or time since injury. These results lend support to our earlier conclusion that corticosteroids should not be used routinely in the treatment of head injury.

Effect of intravenous corticosteroids on death within 14 days in 10008 adults with clinically significant head injury (MRC CRASH trial): randomised placebo-controlled trial.

BACKGROUND: Corticosteroids have been used to treat head injuries for more than 30 years. In 1997, findings of a systematic review suggested that these drugs reduce risk of death by 1-2%. The CRASH trial--a multicentre international collaboration--aimed to confirm or refute such an effect by recruiting 20000 patients. In May, 2004, the data monitoring committee disclosed the unmasked results to the steering committee, which stopped recruitment. METHODS: 10008 adults with head injury and a Glasgow coma score (GCS) of 14 or less within 8 h of injury were randomly allocated 48 h infusion of corticosteroids (methylprednisolone) or placebo. Primary outcomes were death within 2 weeks of injury and death or disability at 6 months. Prespecified subgroup analyses were based on injury severity (GCS) at randomisation and on time from injury to randomisation. Analysis was by intention to treat. Effects on outcomes within 2 weeks of randomisation are presented in this report. This study is registered as an International Standard Randomised Controlled Trial, number ISRCTN74459797. FINDINGS: Compared with placebo, the risk of death from all causes within 2 weeks was higher in the group allocated corticosteroids (1052 [21.1%] vs 893 [17.9%] deaths; relative risk 1.18 [95% CI 1.09-1.27]; p=0.0001). The relative increase in deaths due to corticosteroids did not differ by injury severity (p=0.22) or time since injury (p=0.05). INTERPRETATION: Our results show there is no reduction in mortality with methylprednisolone in the 2 weeks after head injury. The cause of the rise in risk of death within 2 weeks is unclear.