Clinical trial registration: NCT01058746
Objective
To examine, by a prospective randomized controlled trial, the influence of Liberal (LIB) versus Restricted (RES) perioperative fluid administration on morbidity following pancreatectomy.
Summary Background Data
Randomized controlled trials in patients undergoing major intra-abdominal surgery have challenged the historical use of liberal fluid administration, suggesting a more restricted regimen may be associated with fewer postoperative complications.
Methods
Patients scheduled to undergo pancreatic resection were consented for randomization to a LIB (n=164) or RES (n=166) perioperative fluid regimen. Sample size was designed with 80% power to decrease Grade 3 complications from 35% to 21%.
Results
Between July 2009 and July 2015, we randomized 330 patients undergoing pancreaticoduodenectomy (PD, n=218), central (n=16) or distal pancreatectomy (DP, n=96). Patients were equally distributed for all demographic and intraoperative characteristics. Intraoperatively, LIB patients received crystalloid 12ml/kg/hr and RES patients 6ml/kg/hr. Cumulative crystalloid given (median, range, ml) days 0–3 was LIB: 12252 (6600–21365), RES 7808 (2700–16274) p<0.0001. Sixty day mortality was 2/330 (0.6%). Median operative time for PD was 227 minutes (105–462) and DP 150 (44–323). Grade 3 complications occurred in 20% of LIB and 27% of RES patients (p=0.6). Median length of stay was 7 days and 5 days for PD and DP, respectively, in both arms.
Conclusions
In a high volume institution, major perioperative complications from pancreatic resection were not significantly influenced by fluid regimens that differed approximately 1.6 fold.