Document Detail

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.
MedLine Citation:
PMID:  25115420     Owner:  NLM     Status:  In-Data-Review    
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.
Harish Lavu; Naomi M Sell; Timothy I Carter; Jordan M Winter; David P Maguire; David M Gratch; Richard A Berman; Marian G Feil; Zvi Grunwald; Benjamin E Leiby; Edward C Pequignot; Ernest L Rosato; Charles J Yeo
Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Annals of surgery     Volume:  260     ISSN:  1528-1140     ISO Abbreviation:  Ann. Surg.     Publication Date:  2014 Sep 
Date Detail:
Created Date:  2014-08-13     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  0372354     Medline TA:  Ann Surg     Country:  United States    
Other Details:
Languages:  eng     Pagination:  445-55     Citation Subset:  AIM; IM    
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From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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