EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI): study protocol for a multicentre, observational trial

IntroductionMore than 300 million surgical procedures are performed each year. Acute kidney injury (AKI) is a common complication after major surgery and is associated with adverse short-term and long-term outcomes. However, there is a large variation in the incidence of reported AKI rates. The esta...

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Published in:	BMJ open Vol. 11; no. 12; p. e055705
Main Authors:	Kerschke, Laura, Saadi, Omayma, Cherifi, Abdelhadi, Ouyahia, Amel, Aldana, Eduar, Torrado, María Alejandra, Attia, Doaa Ali, Gabr, Mohamed Ahmed, Legros, Vincent, Geneve, Claire, Mauny, Stéphanie Tao, Cousin, Aidren Le, Vautier, Pierre, Magazzeni, Laurent, Magazzeni, Philippe, Elmawieh, Jamil, Falcone, Jeremy, Girardet, Emeline, Ponsonnard, Sébastien, Lefevre, Montaine, Diop, Amanita, Jean-Michel, Vanessa, Latry, Vanessa, Braun, Thierry, Mangeant, Simone, Grand, Hubert, Garçon, Pierre, Pradel, Gaël, Bossion, Florence Prunier, Groote, Thilo Caspar von, Dimski, Thomas, Cleophas, Sebastian, Haunhorst, Stephanie, Flohr, Lena, Häberle, Helene, Leser, Nora Michaela, Stetz, Lena, Boschin, Matthias, Gründel, Matthias, Baumgärtel, Romina, Muras, Lennart, Thal, Serge, Mavrommatis, Efthymios, Pantazi, Danai, Dimakopoulou, Antonia, Dimitropoulou, Katerina, Ingoglia, Gilia, Sollazzi, Liliana, Aceto, Paola, Spadaro, Savino, Vadalà, Maria Cristina, Abdulwahed, Eman, Younes, Eman Sayed, Aliwa, Mohamed, Msherghi, Ahmed, Albarouni, Sufyan, Ekhuja, Taha, Mijovska, Maja Mojsova, Khader, Ahmed, Regufe, Rita de Freitas, Ivkin, Artem, Kumykova, Elmira, Shestov, Alexey, Ahmad Barmou, Abdulnaser Ahmad, Kaserer, Alexander, Akbas, Samira, Petrun, Andreja Möller, Gregorcic, Irena, Wi, Ismail, Becerra-Bolaños, Ángel, Domínguez-Arbelo, Ancor, Munoz, Maria Begona Covas, Matas, Juan Mulet, Teslev, Alisia Cezara, Hinojal, Ignacio, Abasolo, María Gastaca, de la Fuente, Erika Olea, Ferreira, Lourdes, Rezola, Paula Ortega, Casado, Rosalía Navarro, Blasco Blasco, Francho Miguel, Herreros, Natalia Gijón, Jiménez, Andrea Lara, Cobeta, Pilar, Gil, Diego, Galán, Patricia, Manrique, Susana, Villa, Laura Villarino, Mukadder, Orhan Sungur, Altun, Demet, Özdemir, Levent, Boztug, Neval, Tunay, Demet Lafli, Basaran, Burcu, Bingul, Emre Sertac, Girgin, Behic, Demir, Hafize Fisun, Ozcan, Mustafa Soner, Özbilgin, Sule, Cansabuncu, Seda
Format:	Journal Article
Language:	English
Published:	England British Medical Journal Publishing Group 30-12-2021 BMJ Publishing Group LTD BMJ Publishing Group
Series:	Protocol
Subjects:	Acute Kidney Injury - epidemiology Acute Kidney Injury - etiology acute renal failure adult intensive & critical care Anaesthesia Anesthesiology Biomarkers chronic renal failure Cohort Studies Creatinine Epidemiology Heart surgery Hemodialysis Humans Incidence Industrialized nations Intensive care Kidney diseases Low income groups Mortality Multicenter Studies as Topic Observational studies Observational Studies as Topic Participation Patients Prospective Studies Renal Replacement Therapy surgery Urine epidemiology acute renal failure chronic renal failure adult intensive & critical care surgery
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Summary:	IntroductionMore than 300 million surgical procedures are performed each year. Acute kidney injury (AKI) is a common complication after major surgery and is associated with adverse short-term and long-term outcomes. However, there is a large variation in the incidence of reported AKI rates. The establishment of an accurate epidemiology of surgery-associated AKI is important for healthcare policy, quality initiatives, clinical trials, as well as for improving guidelines. The objective of the Epidemiology of Surgery-associated Acute Kidney Injury (EPIS-AKI) trial is to prospectively evaluate the epidemiology of AKI after major surgery using the latest Kidney Disease: Improving Global Outcomes (KDIGO) consensus definition of AKI.Methods and analysisEPIS-AKI is an international prospective, observational, multicentre cohort study including 10 000 patients undergoing major surgery who are subsequently admitted to the ICU or a similar high dependency unit. The primary endpoint is the incidence of AKI within 72 hours after surgery according to the KDIGO criteria. Secondary endpoints include use of renal replacement therapy (RRT), mortality during ICU and hospital stay, length of ICU and hospital stay and major adverse kidney events (combined endpoint consisting of persistent renal dysfunction, RRT and mortality) at day 90. Further, we will evaluate preoperative and intraoperative risk factors affecting the incidence of postoperative AKI. In an add-on analysis, we will assess urinary biomarkers for early detection of AKI.Ethics and disseminationEPIS-AKI has been approved by the leading Ethics Committee of the Medical Council North Rhine-Westphalia, of the Westphalian Wilhelms-University Münster and the corresponding Ethics Committee at each participating site. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and used to design further AKI-related trials.Trial registration numberNCT04165369.
Bibliography:	Protocol ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23
ISSN:	2044-6055 2044-6055
DOI:	10.1136/bmjopen-2021-055705