近日，德国明斯特大学医院Alexander Zarbock团队报道了减少大手术后中度或重度急性肾损伤的预防性护理策略。相关论文于2025年11月13日发表在《柳叶刀》杂志上。

急性肾损伤（AKI）是大手术常见且重要的并发症，但推荐的预防性护理很少得到实施。研究人员使用尿液生物标志物来识别AKI高风险患者，并实施预防性护理策略，以在大手术后72小时内减少AKI。

BigpAK-2是一项在欧洲34家医院进行的多中心随机临床试验。根据预先确定的临床危险因素和肾小管应激生物标志物，接受大手术的AKI高风险患者（年龄≥18岁）被随机分配到常规护理或预防性护理策略，按照肾脏疾病改善全球结局指南的建议：先进的血流动力学监测，优化容量状态和血流动力学，避免肾毒性药物和放射对比剂，预防高血糖。主要结局是在术后72小时内发生中度或重度AKI，在意向治疗人群中进行评估。通过比较组间不良事件发生率来评估安全性。

发现:2020年11月25日至2024年6月21日，共筛查7873例患者，随机分为1180例（15.0%），其中干预组589例（49.9%），对照组591例（50.1%）。在可用于主要终点分析的1176例患者中，干预组中有84例（14.4%）患者发生中度或重度AKI，对照组中有131例（22.3%）患者发生AKI（优势比0.57 [95% CI 0.40 - 0.79; p= 0.0002；需要治疗的人数为12人[7-33]）。两组不良事件发生率无差异。最常见的不良事件是房颤（干预组50例[8.8%]，对照组56例（9.7%））、与血流动力学相关的心律失常（干预组41例[7.2%]，对照组50例[8.6%]）、大出血或出血（干预组34例[6.0%]，对照组31例[5.3%]）和意外返回手术室（干预组29例[5.1%]，对照组38例[6.5%]）。

研究结果表明，在接受大手术的AKI高风险成人中，由支持措施和避免肾毒素组成的预防性护理策略可显著减少中度或重度AKI的发生，而不会增加不良事件。

附：英文原文

Title: A preventive care strategy to reduce moderate or severe acute kidney injury after major surgery (BigpAK-2); a multinational, randomised clinical trial

Author: Alexander Zarbock, Marlies Ostermann, Lui Forni, Christian Bode, Lennart Wild, Christian Putensen, Diego Parise Roux, Elena Elías Martín, Christian Arndt, Tim Rahmel, Silvia de Rosa, Céline Monard, Antoine G Schneider, Adam Glass, Mona Jung-Knig, Stefano Romagnoli, James Gossage, Nuttha Lumlertgul, Jan Gerrit Haaker, Javier Ripollés-Melchor, Savino Spadaro, Antonio Siniscalchi, Emmanuel Futier, Lucie Aupetitgendre, Irene Romero Bhathal, Raquel García álvarez, Alice Bernard, Peter Rosenberger, Carola Wempe, Mahan Sadjadi, Melanie Meersch, Karen Fischhuber, Rinaldo Bellomo, John A Kellum, Thilo von Groote, Wim Vandenberghe, Lander Vanhulle, Eric Hoste, Robin Lalande, Emmanuel Futier, Ugo Schiff, Lucie Aupetitgendre, Alexander Zarbock, Thilo von Groote, Melanie Meersch, Carola Wempe, Mahan Sadjadi, Hendrik Booke, Raphael Weiss, Christian Strau, Dana Meschede, Karen Fischhuber, Moritz Fabian Danzer, Joachim Ger, Jan Gerrit Haaker, Ulrich Michael Gbel, Mona Juliane Brune, André Hemping-Bovenkerk, Thorsten Brenner, Florian Espeter, Marc M Berger, Tim Rahmel, Michael Adamzik, Matthias Unterberg, Britta Marko, Timo Brandenburger, Thomas Dimski, Detlef Kindgen-Milles, Onnen Mrer, Christian Bode, Lennart Wild, Christian Putensen, Philippe Kruse, Konrad Peukert, Andrea Sauer, Alice Bernard, Peter Rosenberger, Helene Hberle, Valbona Mirakaj, Mona Jung-Knig, Jan Larmann, Markus A Weigand, Hans Thomas Hlzer, Indra Wimmelmeier, Stefan Pielmeier, Jrg Reutershan, Richard Ellerkmann, Christian Arndt, Ann-Kristin Schubert, Benjamin Vojnar, Hinnerk Wulf, Andreas Güldner, Martin Mirus, Peter M Spieth, Stefano Romagnoli, Gianluca Villa, Benedetta Mura, Lorenzo Turi, Antonio Siniscalchi, Stefano Tigano, Chiara Capozzi, Carmen Seccafico, Lucia Cattin, Massimo De Cal, Maria Salinas Rojo, Benito Franco DArcangelo, Gaetano Scaramuzzo, Carlo Alberto Volta

Issue&Volume: 2025-11-13

Abstract:

Background

Acute kidney injury (AKI) is a common and important complication of major surgery, yet recommended preventive care is rarely administered. We used urinary biomarkers to identify patients at high risk of AKI and implemented a preventive care strategy to reduce AKI within 72 h after major surgery.

Methods

BigpAK-2 was a multicentre randomised clinical trial done in 34 hospitals in Europe. Patients (aged ≥18 years) undergoing major surgery at high risk for AKI identified by predefined clinical risk factors and tubular stress biomarkers were randomly assigned to usual care or a preventive care strategy as per recommendations by the Kidney Disease Improving Global Outcome guidelines: advanced hemodynamic monitoring, optimisation of volume status and haemodynamics, avoidance of nephrotoxic drugs and radiocontrast agents, and prevention of hyperglycaemia. The primary outcome was the occurrence of moderate or severe AKI within 72 h after surgery, assessed in the intention-to-treat population. Safety was assessed by comparing rates of adverse events between groups. This trial is registered with ClinicalTrials.gov, NCT04647396.

Findings

From Nov 25, 2020, to June 21, 2024, 7873 patients were screened and 1180 (15·0%) were randomly assigned (589 [49·9%] to the intervention group and 591 [50·1%] to the control group). Among the 1176 patients available for the primary endpoint analysis, moderate or severe AKI occurred in 84 (14·4%) patients in the intervention group and in 131 (22·3%) patients in the control group (odds ratio 0·57 [95% CI 0·40–0·79; p=0·0002; number needed to treat 12 [7–33]). There were no differences in adverse events. The most common adverse events were atrial fibrillation (50 [8·8%] in the intervention group vs 56 (9·7%) in the control group), hemodynamically relevant arrhythmias (41 [7·2%] in the intervention group vs 50 [8·6%] in the control group), significant bleeding or haemorrhage (34 [6·0%] in the intervention group vs 31 [5·3%] in the control group), and unplanned return to the operating room (29 [5·1%] in the intervention vs 38 [6·5%] in the control group).

Interpretation

Among adults at high risk for AKI undergoing major surgery, a preventive care strategy consisting of supportive measures and avoidance of nephrotoxins significantly reduced the occurrence of moderate or severe AKI without increasing adverse events.

DOI: 10.1016/S0140-6736(25)01717-9

Source: https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(25)01717-9/abstract