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

作者：Alexander Zarbock, Alexander Zarbock, Marlies Ostermann, Lui G. Forni, Christian Bode, Lennart Wild, Christian Putensen, Diego Parise Roux, E Martin, Christian Arndt, Tim Rahmel, Silvia De Rosa, Céline Monard, Antoine Schneider, Adam Glass, Mona Jung-König, 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, Alexander Zarbock, Thilo von Groote, Melanie Meersch, Carola Wempe, Mahan Sadjadi, Hendrik Booke, Raphael Weiss, Christian Strauß, Dana Meschede, Karen Fischhuber, Moritz Fabian Danzer, Joachim Gerß, Jan Gerrit Haaker, Ulrich Michael Göbel, 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 Mörer, Christian Bode, Lennart Wild, Christian Putensen, Philippe Kruse, Konrad Peukert, Andrea Sauer, Alice Bernard, Peter Rosenberger, Helene Häberle, Valbona Mirakaj, Mona Jung-König, Jan Larmann, Markus A Weigand, Hans Thomas Hölzer, Indra Wimmelmeier, Stefan Pielmeier, Jörg 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 D'Arcangelo, Gaetano Scaramuzzo, Carlo Alberto Volta, Markus W Hollmann, Wolfgang O Bauer, Jenifer S Breel-Tebbutt, Javier Ripollés-Melchor, Paula Fernández-Valdes-Bango, Alicia Ruiz-Escobar, Alfredo Abad-Gurumeta, Diego Parise Roux, Elena Elías Martín, Beatriz Prada De Las Heras, María Gómez-Rojo, Alberto Balvis Balvis, Alejandro Suárez-de-la-Rica, Carlos López, Emilio Maseda, Irene Romero Bhathal, Maider Puyada Jáuregui, Hugo Rivera-Ramos, Marta Antelo Adrán, Rosalia Navarro-Perez, Marta Embid-Rojas, Luis Sante-Serna, Pau Vallhonrat Alcantara, Alejandro Suárez-de-la-Rica, Raquel García Álvarez, Elena Murcia Sánchez, Paula Rodríguez Nieto, Ángel Molero Molinero, Antoine G Schneider, Céline Monard, Jean Daniel Chiche, Yannis Ahmad, Clémence Ferlay, Marlies Ostermann, Morad Sallam, Nuttha Lumlertgul, Ryan Haines, Nurul Zaynah, James Gossage, Nandor Marczin, Alessandra Verzelloni Sef, Marco Scaramuzzi, Adam Glass, Jon Silversides, Elliott Lonsdale, Christine Turley-Rock, Lui Forni, Fizza Haider, Adam Rossiter, Priya Bhogal, Ingeborg D Welters, Jin-Xi Yuan, David Shaw · 发表于：The Lancet · 年份：2025 · DOI：10.1016/s0140-6736(25)01717-9 · 被引用次数：35 · 研究领域：Acute Kidney Injury Research、Trauma, Hemostasis, Coagulopathy, Resuscitation、Chronic Kidney Disease and Diabetes

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 1...