Negative Findings in Hypothermia by Canadians (from today New England Journal)

June 4, 2008

Hypothermia Therapy after Traumatic Brain Injury in Children

S. Hutchison, M.D., Roxanne E. Ward, B.A., Jacques Lacroix, M.D.,

C. Hébert, M.D., M.H.Sc., Marcia A. , Ph.D., Desmond J. Bohn, M.B.,

B. Dirks, M.D., Steve Doucette, M.Sc., Dean Fergusson, Ph.D.,

Gottesman, M.D., Ari R. Joffe, M.D., Haresh M. Kirpalani, M.B., M.Sc.,

Philippe G. Meyer, M.D., P. , M.D., Moher, Ph.D., Ram N.

Singh, M.D., W. Skippen, M.D., for the Hypothermia Pediatric Head

Injury Trial Investigators and the Canadian Critical Care Trials Group

ABSTRACT

Background Hypothermia therapy improves survival and the neurologic outcome

in animal models of traumatic brain injury. However, the effect of

hypothermia therapy on the neurologic outcome and mortality among children

who have severe traumatic brain injury is unknown.

Methods In a multicenter, international trial, we randomly assigned children

with severe traumatic brain injury to either hypothermia therapy (32.5°C for

24 hours) initiated within 8 hours after injury or to normothermia (37.0°C).

The primary outcome was the proportion of children who had an unfavorable

outcome (i.e., severe disability, persistent vegetative state, or death), as

assessed on the basis of the Pediatric Cerebral Performance Category score

at 6 months.

Results A total of 225 children were randomly assigned to the hypothermia

group or the normothermia group; the mean temperatures achieved in the two

groups were 33.1±1.2°C and 36.9±0.5°C, respectively. At 6 months, 31% of the

patients in the hypothermia group, as compared with 22% of the patients in

the normothermia group, had an unfavorable outcome (relative risk, 1.41; 95%

confidence interval [CI], 0.89 to 2.22; P=0.14). There were 23 deaths (21%)

in the hypothermia group and 14 deaths (12%) in the normothermia group

(relative risk, 1.40; 95% CI, 0.90 to 2.27; P=0.06). There was more

hypotension (P=0.047) and more vasoactive agents were administered (P<0.001)

in the hypothermia group during the rewarming period than in the

normothermia group. Lengths of stay in the intensive care unit and in the

hospital and other adverse events were similar in the two groups.

Conclusions In children with severe traumatic brain injury, hypothermia

therapy that is initiated within 8 hours after injury and continued for 24

hours does not improve the neurologic outcome and may increase mortality.

(Current Controlled Trials number, ISRCTN77393684 [controlled-trials.com] .)

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