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The HYSLAR Trial: A Prospective Randomized Controlled Trial of the Use of a Restrictive Fluid Regimen With 3% Hypertonic Saline Versus Lactated Ringers in Patients Undergoing Pancreaticoduodenectomy

Lavu, Harish MD*; Sell, Naomi M. MHS*; Carter, Timothy I. MD*; Winter, Jordan M. MD*; Maguire, David P. MD; Gratch, David M. DO; Berman, Richard A. MD; Feil, Marian G. CRNA; Grunwald, Zvi MD; Leiby, Benjamin E. PhD; Pequignot, Edward C. MS; Rosato, Ernest L. MD*; Yeo, Charles J. MD*

doi: 10.1097/SLA.0000000000000872
Papers of the 134th ASA Annual Meeting
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Objective: This study was designed to determine whether the volume and type of fluid administered for pancreaticoduodenectomy impacts postoperative outcomes.

Background: Three percent hypertonic saline (HYS) has been suggested as a means of reducing the volume of fluid required to sustain tissue perfusion in the perioperative period.

Methods: Between May 2011 and November 2013, patients undergoing pancreaticoduodenectomy were enrolled in an institutional review board–approved, single-center, prospective, parallel, randomized controlled trial (NCT 01428050), comparing lactated Ringers (LAR) (15 mL/kg/hr LAR intraoperation, 2 mL/kg/hr LAR postoperation) with HYS (9 mL/kg/hr LAR and 1 mL/kg/hr HYS intraoperation, 1 mL/kg/hr HYS postoperation).

Results: A total of 264 patients were randomized. Demographic variables between groups were similar. The HYS patients had a significantly reduced net fluid balance (65 vs 91 mL/kg, P = 0.02). The overall complication rate was reduced in the HYS group (43% vs 54%), with a relative risk of 0.79 [95% confidence interval (CI), 0.62–1.02; P = 0.073], factoring stratification for pancreas texture. After adjustment for age and weight, the relative risk was 0.75 [95% CI (0.58–0.96); P = 0.023]. The total number of complications was significantly reduced in the HYS group (93 vs 123), with an incidence rate ratio of 0.74 [95% CI (0.56–0.97); P = 0.027]. After adjustment for age and weight, the incidence rate ratio was 0.69 [95% CI (0.52–0.90); P = 0.0068]. Reoperations, length of stay, readmissions, and 90-day mortality were similar between groups.

Conclusions: A moderately restrictive fluid regimen with HYS resulted in a statistically significant 25% reduction in complications when adjusted for age, weight, and pancreatic texture.

Supplemental Digital Content is Available in the Text.The objective of this study was to determine whether the volume and type of fluid administered for pancreaticoduodenectomy impacts postoperative outcomes. A moderately restrictive fluid regimen with 3% hypertonic saline resulted in a statistically significant 25% reduction in complications when adjusted for age, weight, and pancreatic texture.

*Departments of Surgery

Anesthesia

Biostatistics, Thomas Jefferson University, Jefferson Pancreas Biliary and Related Cancer Center, Philadelphia, PA.

Reprints: Harish Lavu MD, Department of Surgery, Thomas Jefferson University, 1025 Walnut St, Ste 605, Philadelphia, PA 19107. E-mail: harish.lavu@jefferson.edu.

Presented at the 134th Annual Meeting of the American Surgical Association, April 10–12, 2014, Boston, MA.

Disclosure: The authors have no conflicts of interest to declare.

Supplemental digital content is available for this article. Direct URL citations appear in the printed text and are provided in the HTML and PDF versions of this article on the journal's Web site (www.annalsofsurgery.com).

© 2014 by Lippincott Williams & Wilkins.