Intravenous mannitol versus placebo during partial nephrectomy in patients with normal kidney function: A double-blind, clinically-integrated, randomized trial Journal Article
| Authors: | Spaliviero, M.; Power, N. E.; Murray, K. S.; Sjoberg, D. D.; Benfante, N. E.; Bernstein, M. L.; Wren, J.; Russo, P.; Coleman, J. A. |
| Article Title: | Intravenous mannitol versus placebo during partial nephrectomy in patients with normal kidney function: A double-blind, clinically-integrated, randomized trial |
| Abstract: | Background Mannitol is currently used as a renal protective agent to mitigate the effects of renal ischemia during nephron-sparing surgery (NSS). This routine practice lacks rigorous methodological study. Objective To assess the effect on renal function outcomes after surgery of mannitol infusion prior to renal ischemia during NSS. Design, setting, participants This prospective, randomized, placebo-controlled, double-blind trial included 199 patients with a preoperative estimated glomerular filtration rate (eGFR) >45 ml/min/1.73m2 scheduled for NSS; the trial was conducted between July 2012 and July 2015. Intervention Patients undergoing NSS were randomized to receive mannitol (12.5 g) or placebo intravenously within 30 min prior to renal vascular clamping. Outcome measurements and statistical analysis The primary outcome was the difference in eGFR (renal function) between the two groups at 6 mo following surgery assessed with an analysis of covariance model using preoperative eGFR, treatment group, and surgical approach as covariates. Results and limitations At baseline, the median age of the patients was 58 yr, and the median eGFR was 88 ml/min/1.73m2. Comparing placebo with mannitol infusion, the adjusted difference of 0.2 eGFR units at 6 mo was not significant (p = 0.9), with the upper bound of the 95% confidence interval (–3.1 to 3.5) excluding a clinically relevant effect of mannitol. Limitations include evaluation of a single mannitol dose and patients all had excellent preoperative renal function. Conclusions Intraoperative 12.5 g mannitol infusion during NSS has no demonstrable clinical benefit when compared with standardized fluid hydration in patients with normal preoperative renal function, and its use in this setting is not warranted. Patient summary In this randomized trial, patients with normal kidney function who received mannitol during surgery to remove part of their kidney had no better kidney function 6 mo after surgery than those who did not receive mannitol. We conclude that this routine practice should be discontinued. Using intravenous mannitol intraoperatively to mitigate the effects of renal ischemia during nephron-sparing surgery was not associated with improved renal function outcomes in this prospective, randomized, placebo-controlled, double-blind trial; the practice should be discontinued. © 2017 European Association of Urology |
| Keywords: | adult; controlled study; middle aged; cancer surgery; major clinical study; placebo; follow up; prospective study; randomized controlled trial; partial nephrectomy; radical nephrectomy; kidney function; nephron-sparing surgery; kidney ischemia; nephron sparing surgery; single drug dose; kidney cancer; postoperative hemorrhage; double blind procedure; mannitol; hydration; clinical outcome; renal function; estimated glomerular filtration rate; human; male; female; priority journal; article; evaluation study |
| Journal Title: | European Urology |
| Volume: | 73 |
| Issue: | 1 |
| ISSN: | 0302-2838 |
| Publisher: | Elsevier Science, Inc. |
| Date Published: | 2018-01-01 |
| Start Page: | 53 |
| End Page: | 59 |
| Language: | English |
| DOI: | 10.1016/j.eururo.2017.07.038 |
| PROVIDER: | scopus |
| PUBMED: | 28822586 |
| PMCID: | PMC6701857 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 2 January 2018 -- Source: Scopus |
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