AUA 2017: Phase 3 Randomized Trial of Intravenous Mannitol Versus Placebo Prior To Renal Ischemia During Partial Nephrectomy: Impact on Renal Function Outcomes

Boston, MA (UroToday.com) Renal function recovery is a key outcome of nephron sparing surgery (NSS) and mannitol has been used during NSS to reduce the extent of renal function loss as a result of surgery. However, the role of mannitol during NSS has not been prospectively tested or validated, and is based on limited preclinical data on animal models. Additionally, studies have shown that the use of mannitol not only lack benefits on postoperative renal function recovery, but it could also potentially lead to renal failure. In this study, Dr. Spaliviero and colleagues conducted a randomized controlled trial to compare the effects of mannitol versus placebo to protect against the effects of transient renal ischemia and to assess the impact on postoperative renal function in patients undergoing NSS for renal cell cancer.

Patients undergoing open or robot-assisted laparoscopic NSS were randomized to received either mannitol or normal saline solution placebo, within 30 minutes prior to renal artery clamping. A standardized fluid management algorithm was used intraoperatively to maintain hemodynamic stability and urine output, and eGFR was obtained postoperatively at postoperative day 1 and 2, 6 weeks, and 6 months. The primary endpoint of the study was difference in eGFR at 6 months following surgery. A threshold of 6 units of eGFR was used to define clinical significance and two-tailed P-value and a 95% confidence interval (CI) for difference were determined.

Primary and secondary endpoint outcomes and comparison of observed eGFR means in the mannitol arm and placebo arm over the study period showed no significant difference.

Based on their results, the authors concluded that intravenous mannitol infusion during NSS does not lead to clinically relevant improvement in renal function outcomes and should be discontinued.

This poster was awarded best poster of the session.

Presented by: Massimiliano Spaliviero, MD

Authors: Massimiliano Spaliviero, Nicholas E. Power, Katie S. Murray, Daniel D. Sjoberg, Nichole E. Benfante, Melanie L. Bernstein, James Wren, Andrew J. Vickers, Paul Russo, and Jonathan A. Coleman.

Affiliation: Memorial Sloan Kettering Cancer Center, New York, NY, USA

Written By: Susan Li, Department of Urology, School of Medicine, University of California, Irvine, for UroToday.com.

at the 2017 AUA Annual Meeting - May 12 - 16, 2017 – Boston, Massachusetts, USA

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