PD55-01: A prospective single-blinded randomized controlled clinical trial of perioperative goal-directed fluid therapy versus standard fluid therapy for patients undergoing open radical cystectomy on a standardized postoperative enhanced recovery pathway
Friday, May 15, 2020
7:00 AM – 9:00 AM
Sherri M Donat, Kay See Tan, Guido Dalbagni, Alessia C Pedoto, Harry W Herr, Bernard H Bochner, Eugene K Cha, Timothy F Donahue, Mary Fischer, Vittoria Arslan-Carlon
Introduction: Postoperative ileus (POI) is a common complication of intra-abdominal surgeries, including radical cystectomy (RC) with reported POI rates as high as 32%. Targeted individualized perioperative fluid management has been shown to improve postoperative outcomes and POI for abdominal surgeries, compared to standard fluid therapy (SFT). We investigated whether goal-directed fluid therapy (GDFT) during open RC is associated with POI incidence (main outcome) and other perioperative/postoperative complications by 30 days post-surgery.
Methods: This prospective, single-blinded trial at a US cancer center randomized patients undergoing open RC to GDFT or SFT. Participants were =21 years old, had body mass index =45, and no active atrial fibrillation. The algorithm determining amount of fluid to administer combines preoperative and postoperative stroke volume optimization and intraoperative stroke volume variation minimalization, using the EV1000 clinical monitoring platform via a Flotrac sensor. All patients were treated on a standardized postoperative enhanced recovery pathway. Complications were collected prospectively up to 30 days postsurgery using the modified Clavien system and compared between groups using Fisher’s exact test.
Results: Between August 2014 and April 2018, 283 randomized RC patients received their assigned intervention, 142 GDFT and 141 SFT (ClinicalTrials.gov NCT02145871, no longer recruiting patients). Incidence of POI was similar between GDFT and SFT arms (25% vs 21%, p=0.5), as was incidence of grade 3-5 complications (15% vs 16%, p=0.7). Patients in the GDFT arm were more likely to experience at least one complication (96% vs 89%, p=0.028) and acute kidney injury (AKI) (56% vs 40%, p=0.006). All patients with AKI recovered to preoperative baseline by discharge, and no patient required dialysis. Median length of stay was 7 days in both arms (p=0.6), with similar urgent care visit and readmission rates between arms.
Conclusions: In patients undergoing open RC, we found no significant benefit in rate reduction of POI or other high-grade perioperative/postoperative complications with individualized GDFT versus SFT. For future comparison, studies should standardize definitions of outcomes and better delineate their patient populations. Source of
Funding: Supported by the Gary Gladstein Family, the Sidney Kimmel Center for Prostate and Urologic Cancers, Ruth L. Kirschstein National Research Service Award T32CA082088 (MG), and the P30-CA008748 National Institutes of Health cancer center support grant