Is albumin use SAFE in patients with traumatic brain injury?

Abstract

uid resuscitation in patients with traumatic brain injury. N Engl J Med 2007, 357:874-884 [1]. 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 resuscitated with saline. The SAFE investigators conducted a post hoc follow-up study of patients with traumatic brain injury who were enrolled in the study. Methods Objective: The aims of the study were to document baseline characteristics that are known to infl uence outcomes from traumatic brain injury in the albumin and saline groups and to compare death and functional neurologic 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 history of 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%) received four 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 patients with GCS scores of 3 to 8 were classifi ed as having severe brain injury (160 [69.3%] in the albumin group and 158 [69.0%] in the 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, as compared with 42 of 206 in the saline group (20.4%) (relative risk, 1.63; 95% confi dence interval [CI], 1.17 to 2.26; P=0.003). Among patients with severe brain injury, 61 of 146 patients in the albumin group (41.8%) died, as compared with 32 of 144 in the saline group (22.2%) (relative risk, 1.88; 95% CI, 1.31 to 2.70; P<0.001); among patients with GCS scores of 9 to 12, 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 patients with traumatic brain injury, flresuscitation with albumin was associated with higher mortality rates than was resuscitation with saline. (Current Controlled Trials number, ISRCTN76588266.)