Department of Anaesthesia & Perioperative Medicine, Alfred Hospital and Monash University, Melbourne, Vic, Australia.
Department of Intensive Care, Austin Hospital, Melbourne, Vic, Australia; Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, Melbourne, Vic, Australia; School of Medicine, University of Melbourne, Melbourne, Vic, Australia.
Br J Anaesth. 2018 Nov;121(5):1013-1024. doi: 10.1016/j.bja.2018.08.010. Epub 2018 Sep 21.
Renal injury is a common perioperative complication. The adoption of renal endpoints, standardised and valid for use in perioperative clinical trials, would enhance the quality of perioperative clinical research. The Standardised Endpoints in Perioperative Medicine (StEP) initiative was established to derive standardised endpoints for use in perioperative clinical trials.
A systematic review was conducted to identify renal endpoints currently reported in perioperative clinical trials. In parallel, an initial list of candidate endpoints was developed based on renal theme group expertise. A multi-round Delphi consensus process was used to refine this list and produce a suite of recommended perioperative renal outcome measures.
Based on our systematic review, 63 studies were included for analysis. Marked heterogeneity and imprecision of endpoint definitions were observed. Our initial list of candidate endpoints included 10 endpoints for consideration. The response rates for Delphi rounds 1, 2, and 3 were 89% (n=16), 90% (n=75), and 100% (n=6), respectively. A final list of four renal endpoints was identified: acute kidney injury defined by the Kidney Disease: Improving Global Outcomes (KDIGO) consensus criteria, acute kidney disease defined by ≥30% decline in estimated glomerular filtration rate from baseline at 30 days after operation in patients meeting the acute-kidney-injury criteria within 7 days of surgery, the composite of death or renal replacement therapy, and the Major Adverse Kidney Events (MAKE) composite.
We identified four key renal outcome measures that should be considered for use in perioperative clinical trials. Using standardised definitions to capture and report these endpoints will facilitate improved benchmarking and meta-analysis of future trials.
肾损伤是一种常见的围手术期并发症。采用适用于围手术期临床试验的肾脏终点，将提高围手术期临床研究的质量。标准的围手术期医学终点（StEP）倡议旨在为围手术期临床试验制定标准化的终点。
系统评价旨在确定目前在围手术期临床试验中报告的肾脏终点。同时，根据肾脏专题小组的专业知识，初步制定了候选终点清单。多轮 Delphi 共识过程用于完善该清单并生成一系列推荐的围手术期肾脏结局测量指标。
根据我们的系统评价，纳入了 63 项研究进行分析。观察到终点定义的明显异质性和不精确性。我们的候选终点初始清单包括 10 个考虑因素。德尔菲第 1 轮、第 2 轮和第 3 轮的回复率分别为 89%（n=16）、90%（n=75）和 100%（n=6）。确定了四个肾脏终点：肾脏疾病改善全球结局（KDIGO）共识标准定义的急性肾损伤，手术 7 天内符合急性肾损伤标准的患者术后 30 天内估计肾小球滤过率从基线下降≥30%的急性肾疾病定义，死亡或肾脏替代治疗的复合终点以及主要不良肾脏事件（MAKE）复合终点。
我们确定了四个关键的肾脏结局测量指标，应考虑用于围手术期临床试验。使用标准化定义来捕获和报告这些终点将有助于提高未来试验的基准测试和荟萃分析。
