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.

中文翻译：

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肾功能正常患者部分肾切除术中静脉使用甘露醇与安慰剂的比较：一项双盲，临床整合，随机试验

背景

甘露醇目前被用作肾脏保护剂，以减轻保肾手术（NSS）期间肾脏缺血的影响。这种常规做法缺乏严格的方法学研究。

客观的

在NSS肾缺血之前，评估甘露醇输注手术后对肾功能预后的影响。

设计，设置，参与者

这项前瞻性，随机，安慰剂对照，双盲试验纳入了199例接受NSS术前估计肾小球滤过率（eGFR）> 45 ml / min / 1.73m ^2的患者。该试验于2012年7月至2015年7月进行。

干涉

接受NSS的患者在肾血管夹紧前30分钟内随机接受甘露醇（12.5 g）或安慰剂静脉注射。

成果测量和统计分析

主要结局是两组患者术后6 mo的eGFR（肾功能）差异，采用术前eGFR，治疗组和手术方式作为协变量的协方差模型分析进行评估。

结果与局限性

在基线时，患者的中位年龄为58岁，eGFR的中位值为88 ml / min / 1.73m ²。比较安慰剂和甘露醇输注，在6 mo时0.2 eGFR单位的调整差异不显着（p  = 0.9），95％置信区间的上限（–3.1至3.5）不包括甘露醇的临床相关作用。局限性包括评估单次甘露醇剂量，所有患者术前肾功能均良好。

结论

在术前肾功能正常的患者中，术中12.5 g甘露醇的输注与标准液水化相比没有明显的临床益处，因此不保证在这种情况下使用它。

病人总结

在这项随机试验中，肾功能正常的患者在手术后6个月接受了甘露醇去除部分肾脏的肾脏功能比未接受甘露醇的患者在术后6个月没有更好的肾功能。我们得出结论，应停止这种常规做法。