Zarbock Alexander, Gerß Joachim, Van Aken Hugo, Boanta Andreea, Kellum John A, Meersch Melanie
Department of Anesthesiology, Intensive Care and Pain Medicine, University of Münster, Albert-Schweitzer-Campus 1, Gebäude A1, 48149, Münster, Germany.
Institute of Biostatistics and Clinical Research, University of Münster, Münster, Germany.
Trials. 2016 Mar 18;17(1):148. doi: 10.1186/s13063-016-1249-9.
Acute kidney injury remains a common complication in critically ill patients and despite multiple trials and observational studies, the optimal timing for initiation of renal replacement therapy is still unclear. The early versus late initiation of renal replacement therapy in critically ill patients with acute kidney injury (ELAIN) study is a randomized, single-center, prospective, two-arm, parallel group trial to reduce mortality in patients with severe acute kidney injury. We describe the study design and discuss aspects of the need for a trial in this patient cohort.
METHODS/DESIGN: Our plan is to randomize critically ill patients with acute kidney injury to 'early' or 'late' initiation of renal replacement therapy according to stage 2 and 3 of the KDIGO classification using a specific trial protocol. We plan to guide data collection and analysis using pre-existing definitions and testing. The primary endpoint is overall survival in a 90-day follow-up period. Secondary endpoints include 28-day, 60-day, 90-day and 1-year all-cause mortality, recovery of renal function, ICU and hospital length-of-stay. The primary analysis will be an intention-to-treat analysis; secondary analyses include treated analyses. We will also specify rules for handling data and determining outcome.
Several challenges for study design and execution can be seen in our trial, and it should generate results that will inform and influence the practice of renal replacement therapy in critically ill patients with acute kidney injury.
German Clinical Trials Register: DRKS00004367 ( www.germanctr.de ); 28 May 2013.
急性肾损伤仍是重症患者常见的并发症，尽管进行了多项试验和观察性研究，但开始肾脏替代治疗的最佳时机仍不明确。急性肾损伤重症患者肾脏替代治疗早期与晚期启动（ELAIN）研究是一项随机、单中心、前瞻性、双臂、平行组试验，旨在降低重症急性肾损伤患者的死亡率。我们描述了该研究设计，并讨论了在这一患者群体中进行试验的必要性。
方法/设计：我们计划根据KDIGO分类的2期和3期，使用特定试验方案将急性肾损伤重症患者随机分为肾脏替代治疗“早期”或“晚期”启动组。我们计划使用预先存在的定义和检测方法来指导数据收集和分析。主要终点是90天随访期内的总生存率。次要终点包括28天、60天、90天和1年的全因死亡率、肾功能恢复情况、重症监护病房（ICU）和住院时间。主要分析将采用意向性分析；次要分析包括治疗分析。我们还将明确处理数据和确定结果的规则。
在我们的试验中可以看到研究设计和实施面临的几个挑战，它应该能产生结果，为急性肾损伤重症患者的肾脏替代治疗实践提供信息并产生影响。
德国临床试验注册中心：DRKS00004367（www.germanctr.de）；2013年5月28日。
