Document Type

Article

Original Publication Date

2001

Journal/Book/Conference Title

The New England Journal of Medicine

Volume

344

DOI of Original Publication

10.1056/NEJM200102223440803

Comments

Originally Published at http://dx.doi.org/10.1056/NEJM200102223440803

Date of Submission

January 2015

Abstract

Background

Induction of hypothermia in patients with brain injury was shown to improve outcomes in small clinical studies, but the results were not definitive. To study this issue, we conducted a multicenter trial comparing the effects of hypothermia with those of normothermia in patients with acute brain injury.

Methods

The study subjects were 392 patients 16 to 65 years of age with coma after sustaining closed head injuries who were randomly assigned to be treated with hypothermia (body temperature, 33°C), which was initiated within 6 hours after injury and maintained for 48 hours by means of surface cooling, or normothermia. All patients otherwise received standard treatment. The primary outcome measure was functional status six months after the injury.

Results

The mean age of the patients and the type and severity of injury in the two treatment groups were similar. The mean (±SD) time from injury to randomization was 4.3±1.1 hours in the hypothermia group and 4.1±1.2 hours in the normothermia group, and the mean time from injury to the achievement of the target temperature of 33°C in the hypothermia group was 8.4±3.0 hours. The outcome was poor (defined as severe disability, a vegetative state, or death) in 57 percent of the patients in both groups. Mortality was 28 percent in the hypothermia group and 27 percent in the normothermia group (P=0.79). The patients in the hypothermia group had more hospital days with complications than the patients in the normothermia group. Fewer patients in the hypothermia group had high intracranial pressure than in the normothermia group.

Conclusions

Treatment with hypothermia, with the body temperature reaching 33°C within eight hours after injury, is not effective in improving outcomes in patients with severe brain injury. (N Engl J Med 2001; 344:556-63.)

Rights

From The New England Journal of Medicine, Clifton G. L., Miller, E. R., Choi, S. C. et al., Lack of Effect of Induction of Hypothermia after Acute Brain Injury, Vol. 344, Page 556, Copyright © 2001 Massachusetts Medical Society. Reprinted with permission.

Is Part Of

VCU Biostatistics Publications

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