术后 20% 白蛋白与心脏手术相关性肾损伤、统计分析计划和更新方案

Mayurathan Balachandran, Adrian Pakavakis, Wisam Al-Bassam, David Collins, Raffaele Mandarano, Vineet Sarode, Rinaldo Bellomo, Alastair Brown, Shailesh Bihari, Mozhu Li, Alana Brown, Yahya Shehabi
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引用次数: 0

摘要

背景心脏手术相关急性肾损伤(CS-AKI)的发病率仍然很高。心脏手术后发生急性肾损伤的患者出现持续性肾功能不全和长期死亡率升高的风险较高。慢性肾脏病患者和因复杂手术而延长搭桥时间的患者发生 CS-AKI 的风险明显增加。之前的白蛋白试验并未显示出预防 CS-AKI 的任何益处。不过,这些试验并未将重点放在高危患者身上,也未将白蛋白作为复苏策略。ALBICS-AKI 的目的是证明与标准护理相比,高浓度白蛋白输注对心脏手术高危患者 CS-AKI 的影响。方法ALBICS-AKI是一项由研究者发起的多中心、随机、开放标签试验。澳大利亚和意大利的七个中心将参与该试验。我们将随机抽取 620 名接受泵上心脏手术的成年患者,这些患者必须符合以下条件之一:估计肾小球滤过率为 60 ml/min/1.73m2、合并瓣膜/s、冠状动脉或涉及胸主动脉的手术。手术后 6 小时内,将以 20 毫升/小时的速度开始输注 20% 的白蛋白,持续 15 小时。所有患者都将按照机构协议接受标准护理。主要结果是根据基于肌酐的 KDIGO 定义,出院时或第 28 天(以先到者为准)出现 AKI 的患者比例。次要结果包括第 28 天的主要肾脏不良事件、AKI II 期和 III 期、肾脏替代治疗需求和住院死亡率。伦理和传播 澳大利亚研究机构的试验已获得莫纳什卫生领导研究委员会的批准,意大利研究机构的试验已获得意大利医药局的批准。预计研究完成日期为 2024 年 9 月。研究结果将在重要会议上公布,并在同行评审期刊上发表。试验注册号:澳大利亚-新西兰临床试验注册中心 ACTRN12619001355167
本文章由计算机程序翻译,如有差异,请以英文原文为准。
Postoperative 20% Albumin and Cardiac Surgery Associated Kidney Injury, Statistical Analysis Plan and Updated Protocol
Background The incidence of cardiac surgery associated acute kidney injury (CS-AKI) remains high. Patients who develop AKI after cardiac surgery are at higher risk of persistent renal dysfunction and increased long-term mortality. The risk of CS-AKI is significantly increased in patients with chronic kidney disease and in patients having prolonged bypass for complex surgery. Previous trials of albumin did not show any benefit in prevention of CS-AKI. These trials, however, did not focus on high-risk patients and used albumin as a resuscitation strategy. The aim of ALBICS-AKI is to demonstrate the effect of concentrated albumin infusion on CS-AKI in high-risk patients undergoing cardiac surgery compared with standard care. Methods ALBICS-AKI is an investigator initiated, multicentre, randomised, open label trial. Seven centres in Australia and Italy will participate in the trial. We will randomise 620 adult patients who will undergo on-pump cardiac surgery with one of the following: an estimated glomerular filtration rate <60 ml/min/1.73m2, combined valve/s, coronary artery, or surgery involving thoracic aorta. Within 6 hours after surgery, a 20% albumin infusion will commence at 20ml/h for 15 hours. All patients will receive standard care as per institutional protocols. The primary outcome is the proportion of patients with AKI according to creatinine based KDIGO definition at hospital discharge or day 28, whichever comes first. Secondary outcomes include Major Adverse Kidney Events at day 28, AKI stage II and III, need for renal replacement therapy, and hospital mortality. Ethics and dissemination The trial was approved by Monash Health Lead Research Committee for Australian sites and by the Italian Medicine Agency for Italian sites. The estimated study completion date is Sep 2024. The results will be presented at major conferences and submitted for publication in peer-reviewed journals. Trial registration number Australian New Zealand Clinical Trials Registry ACTRN12619001355167
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