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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.

SUBMITTER: Wong NC

PROVIDER: S-EPMC8560079 | biostudies-literature |

REPOSITORIES: biostudies-literature

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Project description:Background and objectiveNephron sparing surgery (NSS) is the preferred management for clinical stage T1 (cT1) renal masses. In recent years, indications have expanded to larger and more complex renal tumors. In an effort to provide optimal patient outcomes, urologists strive to achieve the pentafecta when performing partial nephrectomy. This has led to the continuous technologic advancement and technique refinement including the use of augmented reality, ultrasound techniques, changes in surgical approach and reconstruction, uses of novel fluorescence marker guided imaging, and implementation of early recovery after surgery (ERAS) protocols. The aim of this narrative review is to provide an overview of the recent advances in pre-, intra-, and post-operative management and approaches to managing patients with renal masses undergoing NSS.MethodsWe performed a non-systematic literature search of PubMed and MEDLINE for the most relevant articles pertaining to the outlined topics from 2010 to 2022 without limitation on study design. We included only full-text English articles published in peer-reviewed journals.Key content and findingsPartial nephrectomy is currently prioritized for cT1a renal masses; however, indications have been expanding due to a greater understanding of anatomy and technologic advances. Recent studies have demonstrated that improvements in imaging techniques utilizing cross-sectional imaging with three-dimensional (3D) reconstruction, use of color doppler intraoperative ultrasound, and newer studies emerging using contrast enhanced ultrasound play important roles in certain subsets of patients. While indocyanine green administration is commonly used, novel fluorescence-guided imaging including folate receptor-targeting fluorescence molecules are being investigated to better delineate tumor-parenchyma margins. Augmented reality has a developing role in patient and surgical trainee education. While pre-and intra-operative imaging have shown to be promising, near infrared guided segmental and sub-segmental vessel clamping has yet to show significant benefit in patient outcomes. Studies regarding reconstructive techniques and replacement of reconstruction with sealing agents have a promising future. Finally, ERAS protocols have allowed earlier discharge of patients without increasing complications while improving cost burden.ConclusionsAdvances in NSS have ranged from pre-operative imaging techniques to ERAS protocols Further prospective investigations are required to determine the impact of novel imaging, in-vivo fluorescence biomarker use, and reconstructive techniques on achieving the pentafecta of NSS.

Project description:BackgroundMannitol 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.ObjectiveTo assess the effect on renal function outcomes after surgery of mannitol infusion prior to renal ischemia during NSS.Design, setting, participantsThis prospective, randomized, placebo-controlled, double-blind trial included 199 patients with a preoperative estimated glomerular filtration rate (eGFR) >45ml/min/1.73m2 scheduled for NSS; the trial was conducted between July 2012 and July 2015.InterventionPatients undergoing NSS were randomized to receive mannitol (12.5g) or placebo intravenously within 30min prior to renal vascular clamping.Outcome measurements and statistical analysisThe 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 limitationsAt baseline, the median age of the patients was 58 yr, and the median eGFR was 88ml/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.ConclusionsIntraoperative 12.5g 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 summaryIn 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.

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Phase III Trial of Intravenous Mannitol Versus Placebo During Nephron-sparing Surgery: Post Hoc Analysis of 3-yr Outcomes.

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