title: 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.
abstract: 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.
authors.affiliation: *Departments of Surgery †Anesthesia ‡Biostatistics, Thomas Jefferson University, Jefferson Pancreas Biliary and Related Cancer Center, Philadelphia, PA.
authors.forename: Harish
authors.initials: H
authors.lastname: Lavu
authors.forename: Naomi M
authors.initials: NM
authors.lastname: Sell
authors.forename: Timothy I
authors.initials: TI
authors.lastname: Carter
authors.forename: Jordan M
authors.initials: JM
authors.lastname: Winter
authors.forename: David P
authors.initials: DP
authors.lastname: Maguire
authors.forename: David M
authors.initials: DM
authors.lastname: Gratch
authors.forename: Richard A
authors.initials: RA
authors.lastname: Berman
authors.forename: Marian G
authors.initials: MG
authors.lastname: Feil
authors.forename: Zvi
authors.initials: Z
authors.lastname: Grunwald
authors.forename: Benjamin E
authors.initials: BE
authors.lastname: Leiby
authors.forename: Edward C
authors.initials: EC
authors.lastname: Pequignot
authors.forename: Ernest L
authors.initials: EL
authors.lastname: Rosato
authors.forename: Charles J
authors.initials: CJ
authors.lastname: Yeo
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D016063:Blood Loss, Surgical; D019091:Critical Pathways; D005260:Female; D005440:Fluid Therapy / Q000379:methods; D006801:Humans; D007552:Isotonic Solutions / Q000008:administration & dosage*; D008297:Male; D008875:Middle Aged; D010190:Pancreatic Neoplasms / Q000517:prevention & control; D016577:Pancreaticoduodenectomy / Q000706:statistics & numerical data; D011182:Postoperative Care / Q000706:statistics & numerical data; D011183:Postoperative Complications / Q000453:epidemiology / Q000517:prevention & control*; D011446:Prospective Studies; D000077325:Ringer's Lactate; D012462:Saline Solution, Hypertonic / Q000008:administration & dosage*
chemical_list: D007552:Isotonic Solutions; D000077325:Ringer's Lactate; D012462:Saline Solution, Hypertonic