INDIVIDUAL PATIENT COHORT ANALYSIS OF THE EFFICACY OF HYPERTONIC SALINE DEXTRAN IN PATIENTS WITH TRAUMATIC BRAIN INJURY AND HYPOTENSION/

Background: Resuscitation with hypertonic saline/dextran (HSD) has bee n suggested to be efficacious in patients who have traumatic brain inj ury and are hypotensive. We undertook a cohort analysis of individual patient data from previous prospective randomized double-blinded trial s to evaluate improvements in survival at 24 hours and discharge after initial treatment with HSD in patients who had traumatic brain injury (head region Abbreviated Injury Score greater than or equal to 4) and hypotension (systolic blood pressure less than or equal to 90 mm Hg). Methods: All variables and end points were defined before initiation of data handling. Investigators were blind as to the treatment. Case r eport forms were received from six studies. Of these, 223 patients met the inclusion for traumatic brain injury. Comparisons between HSD and standard of care were made using stratified analysis and logistic reg ression to assess efficacy, confounding, and interaction. Potential co nfounding variables of pre-fluid treatment, Glasgow Coma Scale score ( 3-8 vs. 9-15), injury type, and systolic blood pressure can be conside red a priori factors that were known before randomization. Effects of the various trials was also considered. Results: Treatment with HSD re sulted in a survival until discharge of 37.9% (39 of 103) compared wit h 26.9% (32 of 119) with standard of care (p = 0.080). Using logistic regression, adjusting for trial and potential confounding variables, t he treatment effect can be summarized by the odds ratio of 2.12 (p = 0 .048) for survival until discharge. Conclusion: Patients who have trau matic brain injuries in the presence of hypotension and receive HSD ar e about twice as likely to survive as those who receive standard of ca re.