Christopher R Brackney, Luis A Diaz, Eric B Milbrandt, Ali Al-Khafaji and Joseph M Darby*. Critical Care 2010, 14:307
Background
The Saline versus Albumin Fluid Evaluation study suggested that patients with traumatic brain injury resuscitated with albumin had a higher mortality rate than those resuscitatedwith saline. The SAFE investigators conducted a post hoc follow-up study of patientswith traumatic brain injury who were enrolled in the study.
Methods
Objective: The aims of the study were to document baseline characteristicsthat are known to inl uence outcomes from traumatic brain injuryin the albumin and saline groups and to compare death and functionalneurologic outcomes in the two groups 24 months after randomization.
Design: A post hoc follow-up study of patients with traumatic brain injury who were enrolled in the SAFE study.
Setting: Intensive care units of 16 academic tertiary hospitals in Australia and New Zealand.
Subjects: 460 patients 18 years or older with traumatic brain injury (i.e., a historyof trauma, evidence of head trauma on a computed tomographic[CT] scan, and a score of 13 on the Glasgow Coma Scale [GCS]).
Intervention: 231 (50.2%) receivedfour percent albumin and 229 (49.8%) received saline.
Outcomes: The primary outcome measures were the mortality rate and functional neurologic outcome 24 months after randomization. Multivariate logistic-regression was used to adjustment for baseline covariates known to be associated with increased mortality from traumatic brain injury (age older than 60 years, GCS score of 8, systolic pressure of <90 mm Hg, and traumatic subarachnoid hemorrhage). Analyses were conducted in all patients and in subgroups according to severity of traumatic brain injury.
Results
The subgroup of patientswith GCS scores of 3 to 8 were classii ed as having severe braininjury (160 [69.3%] in the albumin group and 158 [69.0%] inthe saline group). Demographic characteristics and severity of brain injury were similar at baseline. At 2 years,71 of 214 patients in the albumin group (33.2%) had died, ascompared with 42 of 206 in the saline group (20.4%) (relativerisk, 1.63; 95% coni dence interval [CI], 1.17 to 2.26; P=0.003).Among patients with severe brain injury, 61 of 146 patientsin the albumin group (41.8%) died, as compared with 32 of 144in the saline group (22.2%) (relative risk, 1.88; 95% CI, 1.31to 2.70; P<0.001); among patients with GCS scores of 9 to12, death occurred in 8 of 50 patients in the albumin group(16.0%) and 8 of 37 in the saline group (21.6%) (relative risk,0.74; 95% CI, 0.31 to 1.79; P=0.50).
Conclusions
In this post hoc study of critically ill patientswith traumatic brain injury, l uid resuscitation with albumin was associated with higher mortality rates than was resuscitationwith saline. (Current Controlled Trials number, ISRCTN76588266.)
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