Hypotermie u TBI – up to date 2011 - Česká společnost ...

Clifton Lancet Neurology 2010
The NABIS: H II trial therefore tested the effects of very early hypothermia in
adults with severe nonpenetrating brain injury. Enrollment occurred from
December 2005 to June 2009, when the trial was terminated for futility.
There was concern over slow accrual and patient safety, the investigators
say.
The primary analysis centers on 97 patients — 52 in the hypothermia group
and 45 in the normothermia group — who were followed up from June
2006 to December 2009.
For patients in the hypothermia group, the mean time to reach 35°C was 2.6
hours and to reach 33°C was 4.4 hours. Hypothermia was maintained for a
fixed duration of 48 hours.
According to the investigators, poor outcomes (severe disability, vegetative
state, or death) were equally common and not significantly different in the
hypothermia group and the normothermia group.
Table 1. Poor Outcome by Treatment
Primary Analysis Hypothermia, No. (%) (n = 52)
Normothermia, No. (%) (n = 45)
RR (95% CI) P Value Poor outcome31 (60)25 (56)1.08 (0.76 – 1.53).67CI =
confidence interval; RR = relative risk