Phase III trial of intravenous mannitol versus placebo during nephron-sparing surgery: Post hoc analysis of 3-yr outcomes Journal Article
| Authors: | Wong, N. C.; Alvim, R. G.; Sjoberg, D. D.; Shingarev, R.; Power, N. E.; Spaliviero, M.; Murray, K. S.; Benfante, N. E.; Hakimi, A. A.; Russo, P.; Coleman, J. A. |
| Article Title: | Phase III trial of intravenous mannitol versus placebo during nephron-sparing surgery: Post hoc analysis of 3-yr outcomes |
| Abstract: | Our recently reported phase III trial demonstrated that patients undergoing nephron-sparing surgery (NSS) with an estimated glomerular filtration rate (eGFR) of ≥45 ml/min/1.73 m2 who received mannitol had no improvement in renal function at 6 mo compared with those who received placebo. Some authors have suggested that benefit is restricted to subgroups, such as those with comorbidities. We assessed whether preoperative eGFR, or other patient and surgical factors modified the effect of mannitol on postoperative outcomes at 6 mo and with extended follow-up. We also assessed whether mannitol was associated with differences in long-term GFR years after surgery. No significant difference between the mannitol or placebo groups (mean eGFR difference: 1.4; 95% confidence interval: –2.6, 5.3; p = 0.5) was found in the 134 patients with known eGFR at 3 yr after NSS. At both 6 mo and 3 yr, the effect of mannitol was not significantly modified by patient or surgical factors including preoperative eGFR. In summary, we validated our original trial conclusions by finding that intraoperative use of mannitol does not improve either short- or long-term renal function in patients undergoing NSS. Specifically, there is no evidence that comorbidities, including lower preoperative eGFR, modify the effect of mannitol. Patient summary: Use of mannitol at the time of partial nephrectomy does not improve either short- or long-term renal function even in patients with comorbidities, including lower preoperative renal function. The routine use of intraoperative mannitol should be discontinued. © 2019 Use of mannitol at the time of partial nephrectomy does not improve either short- or long-term renal function even in patients with comorbidities, including lower preoperative renal function. The routine use of intraoperative mannitol should be discontinued. © 2019 |
| Keywords: | controlled study; treatment outcome; major clinical study; postoperative period; placebo; drug efficacy; follow up; partial nephrectomy; preoperative period; kidney tumor; kidney function; nephron-sparing surgery; nephron sparing surgery; intraoperative period; comorbidity; mannitol; function; post hoc analysis; renal; estimated glomerular filtration rate; human; article |
| Journal Title: | European Urology Focus |
| Volume: | 5 |
| Issue: | 6 |
| ISSN: | 2405-4569 |
| Publisher: | Elsevier B.V. |
| Date Published: | 2019-11-01 |
| Start Page: | 977 |
| End Page: | 979 |
| Language: | English |
| DOI: | 10.1016/j.euf.2019.04.003 |
| PUBMED: | 31029560 |
| PROVIDER: | scopus |
| PMCID: | PMC8560079 |
| DOI/URL: | |
| Notes: | Article -- Export Date: 2 December 2019 -- Source: Scopus |
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