Table 4.
Safety Outcomes within 7 Days after Randomization and 28-Day Mortality.
| Outcome | Hypothermia Group (N = 46) |
Normothermia Group (N = 28) |
P value* |
|---|---|---|---|
| Blood-product use | |||
| Overall (Any type) | 23 (50%) | 8 (29%) | 0.08 |
| Cryoprecipitate | 1 (2%) | 0 (0%) | 0.62 |
| Fresh frozen plasma | 15 (33%) | 5 (18%) | 0.18 |
| Packed red blood cells/whole blood | 15 (33%) | 4 (14%) | 0.09 |
| Platelets | 3 (7%) | 0 (0%) | 0.23 |
| Arrhythmias | |||
| Any serious arrhythmias | 3 (7%) | 3 (11%) | 0.55 |
| Asystole | 1 (2%) | 3 (11%) | 0.17 |
| Atrial (SVT, atrial flutter, JET) | 1 (2%) | 0 (0%) | 0.62 |
| Pulseless electrical activity (PEA) | 1 (2%) | 0 (0%) | 0.62 |
| Ventricular (sustained VT greater than 30 secs, VF, Torsades) |
0 (0%) | 0 (0%) | 1.00 |
| Other | 1 (2%) | 1 (4%) | 0.76 |
| Culture-proven infections** | |||
| Overall (Any) | 31 (67%) | 12 (43%) | 0.04 |
| Blood | 3 (7%) | 2 (7%) | 0.91 |
| Respiratory | 23 (50%) | 9 (32%) | 0.14 |
| Urine | 6 (13%) | 2 (7%) | 0.47 |
| Total number of infections | |||
| Overall | 36 | 14 | |
| Blood | 3 | 2 | |
| Respiratory | 26 | 10 | |
| Urine | 7 | 2 | |
| Number of days at risk | 323 | 166 | |
| Rate (95% CI) of infections per 100 days at risk† |
|||
| Overall | 11.1 (7.8, 15.4) | 8.4 (4.6, 14.2) | 0.46† |
| Blood | 0.9 (0.2, 2.7) | 1.2 (0.1, 4.4) | 1.00 |
| Respiratory | 8.0 (5.3, 11.8) | 6.0 (2.9, 11.1) | 0.49 |
| Urine | 2.2 (0.9, 4.5) | 1.2 (0.1, 4.4) | 0.73 |
| All cause 28-day mortality | 22 (48%) | 14 (50%) | 0.86 |
*
P values for all comparisons, except where noted, are 2-sided mid p-values, based on an exact likelihood ratio test.
†
Confidence intervals are exact two-sided 95% CIs, and p-values are based on an exact test of homogeneity of event rates between the Hypothermia arm and the Normothermia arm, assuming event data follow Poisson distributions.
**
For completeness: one eye culture with stenotrophomonas maltophilia andstaphylococcus coagulase negative (excluded); Respiratory culture isolation of Adenovirus; parainfluenza excluded; one blood culture with diphtheroids (excluded).