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Individual Patient Cohort Analysis of the Efficacy of Hypertonic Saline/Dextran in Patients with Traumatic Brain Injury and Hypotension

Wade, C. E. PhD; Grady, J. J. PhD; Kramer, G. C. PhD; Younes, R. N. MD; Gehlsen, K. PhD; Holcroft, J. W. MD

Journal of Trauma-Injury Infection & Critical Care: May 1997 - Volume 42 - Issue 5S - pp 61S-65S
14Th Bodensee Symposium On Microcirculation: Small Volume Resuscitation In Head Injury, Bodensee, Germany, June 14-16, 1996: Article

Background: Resuscitation with hypertonic saline/dextran (HSD) has been suggested to be efficacious in patients who have traumatic brain injury and are hypotensive. We undertook a cohort analysis of individual patient data from previous prospective randomized double-blinded trials 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 > or = to 4) and hypotension (systolic blood pressure < or = 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 report 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 regression to assess efficacy, confounding, and interaction. Potential confounding variables of pre-fluid treatment, Glasgow Coma Scale score (3-8 vs. 9-15), injury type, and systolic blood pressure can be considered a priori factors that were known before randomization. Effects of the various trials was also considered.

Results: Treatment with HSD resulted in a survival until discharge of 37.9% (39 of 103) compared with 26.9% (32 of 119) with standard of care (p = 0.080). Using logistic regression, adjusting for trial and potential confounding variables, the treatment effect can be summarized by the odds ratio of 2.12 (p = 0.048) for survival until discharge.

Conclusion: Patients who have traumatic brain injuries in the presence of hypotension and receive HSD are about twice as likely to survive as those who receive standard of care.

From the Medisan Pharmaceuticals Inc. (C.E.W.), Uppsala, Sweden, Departments of Biostatistics (J.J.G.), and Anesthesiology (G.C.K.), University of Texas Medical Branch, Galveston, Texas, Trauma Service and Department of Surgery (R.N.Y.), University of Sao Paulo School of Medicine, Sao Paulo, Brazil, Sidney Kimmel Cancer Center (K.G.), San Diego, California, and Department of Surgery (J.W.H.), School of Medicine, University of California, Davis Medical Center, Sacramento, California.

Address for reprints: Dr. Charles Wade, 109 Pearl, Sausalito, CA 94965.

© Williams & Wilkins 1997. All Rights Reserved.