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Ann Surg. 2014 Sep;260(3):445-55. doi: 10.1097/SLA.0000000000000872.

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.

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  • 1*Departments of Surgery †Anesthesia ‡Biostatistics, Thomas Jefferson University, Jefferson Pancreas Biliary and Related Cancer Center, Philadelphia, PA.

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.

PMID:
25115420
[PubMed - in process]
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