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The HYSLAR Trial: A Prospective Randomized Trial on the Use of a Restrictive Fluid Regimen with 3% Hypertonic Saline (HS) versus Lactated Ringers (LR) in Patients Undergoing Pancreaticoduodenectomy (PD)
Harish Lavu*, Naomi Sell*, Jordan Winter*, Timothy Carter*, David Maguire*, David Gratch*, Marian Feil*, Richard Berman*, Zvi Grunwald*, Benjamin Leiby*, Edward Pequignot*, Ernest Rosato, Charles Yeo
Thomas Jefferson University, Philadelphia, PA
OBJECTIVE(S):
Restrictive fluid regimens have been shown to reduce perioperative complications in patients undergoing surgery. The objective of this study was to determine if the volume and type of fluid administered during and after PD impacts postoperative outcomes.
METHODS:
Between May 2011 and November 2013, patients undergoing PD were consented and enrolled in an IRB approved, prospective, randomized trial (NCT 01428050). At laparotomy, patients were stratified by gland texture (soft vs hard) and randomized to LR (15ml/kg/hr LR intraop, and 2ml/kg/hr LR postop until the morning of POD #1) or HS (9ml/kg/hr LR and 1ml/kg/hr HS intraop, and 1ml/kg/hr HS postop until the morning of POD #1). The trial was powered to detect a 30% reduction in the overall rate of complications (80% power, alpha= 0.05, chi-squared test).
RESULTS:
There were 245 patients, with 122 and 123 in the LR and HS groups, respectively. Demographic variables between groups were similar (Table). The LR patients had a significantly greater net fluid balance (91 vs 65 ml/kg, p=0.02) for the entire admission. The overall complication rate (54% vs 41%, p<0.05) and the cumulative number of complications (120 vs 80, p=0.01), were significantly greater in the LR group. Reoperation rate, length of stay, readmission rate, and 30 day mortality were similar between groups.
CONCLUSIONS:
A restrictive fluid regimen with 3% HS significantly reduces complications in patients undergoing PD.
| Lactated Ringers (n=122) | Hypertonic Saline (n=123) | p value | Lactated Ringers (n=122) | Hypertonic Saline (n=123) | p value | |||
| Age (years) | 68.6 | 66.6 | NS | Subjects with Complications | 66 (54%) | 50 (41%) | <0.05 | |
| BMI | 25.3 | 26.8 | NS | Cumulative Complications | 120 | 80 | 0.01 | |
| Preop Albumin | 4.2 | 4.1 | NS | Pancreatic Fistula | 20 (16%) | 18 (15%) | NS | |
| Estimated Blood Loss (ml) | 400 | 350 | NS | Delayed Gastric Emptying | 21 (17%) | 13 (11%) | NS | |
| Fluid Intake Intraop (ml/kg/hr) | 14.8 | 10.9 | <0.001 | Intra-Abdominal Abscess | 20 (16%) | 9 (7%) | <0.03 | |
| Intake for Entire Admission (ml/kg) | 316 | 274 | 0.006 | Reoperative Rate | 1 (1%) | 4 (3%) | NS | |
| Output for Entire Admission (ml/kg) | 213 | 212 | NS | Length of Stay (days) | 7 | 7 | NS | |
| Total Admission Balance (ml/kg) | 91 | 65 | 0.02 | Readmission Rate | 13 (11%) | 15 (12%) | NS | |
| Pathology: Pancreatic and Periampullary Cancer | 88 (72%) | 84 (68%) | NS | 30 day Mortality | 1 (1%) | 0 (0%) | NS |
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