Open access Protocol BMJ Open: first published as 10.1136/bmjopen-2021-055705 on 30 December 2021. Downloaded from http://bmjopen.bmj.com/ on October 6, 2023 at Univesity Autonomous of Barcelona. EPIdemiology of Surgery-­Associated Acute Kidney Injury (EPIS-­AKI): study protocol for a multicentre, observational trial Raphael Weiss,1 Khaschayar Saadat-­Gilani,1 Laura Kerschke,2 Carola Wempe,1 Melanie Meersch ‍ ‍,1 Alexander Zarbock ‍ ‍,1 the EPIS-­AKI Investigators To cite: Weiss R, Saadat-­ ABSTRACT Gilani K, Kerschke L, et al. Introduction More than 300 million surgical procedures STRENGTHS AND LIMITATIONS OF THIS STUDY EPIdemiology of Surgery-­ are performed each year. Acute kidney injury (AKI) is ⇒ The trial will be conducted as an internation- Associated Acute Kidney al prospective, observational, multicentre, cohort a common complication after major surgery and is Injury (EPIS-­AKI): study study investigating the epidemiology of surgery-­ associated with adverse short-­term and long-­term protocol for a multicentre, outcomes. However, there is a large variation in the associated acute kidney injury (AKI) according to the observational trial. BMJ Open 2021;11:e055705. doi:10.1136/ incidence of reported AKI rates. The establishment of current Kidney Disease: Improving Global Outcomes bmjopen-2021-055705 an accurate epidemiology of surgery-­associated AKI is definition of AKI. important for healthcare policy, quality initiatives, clinical ⇒ The trial has several strengths: a large cohort of ► Prepublication history and patients, an international setting with diverse con- trials, as well as for improving guidelines. The objective additional supplemental material tinents, regions and countries participating as well of the Epidemiology of Surgery-­associated Acute Kidney for this paper are available Protected by copyright. Injury (EPIS-­AKI) trial is to prospectively evaluate the as the large different types of surgeries and patients online. To view these files, please visit the journal online epidemiology of AKI after major surgery using the latest allow a universal analysis of the epidemiology of (http://dx.doi.org/10.1136/​ Kidney Disease: Improving Global Outcomes (KDIGO) surgery-­associated AKI. bmjopen-2021-055705). consensus definition of AKI. ⇒ An add-­on study will evaluate novel biomarkers for Methods and analysis EPIS-­AKI is an international early detection of AKI and to distinguish between Received 21 July 2021 prospective, observational, multicentre cohort study transient and persistent AKI. Accepted 26 November 2021 including 10 000 patients undergoing major surgery who ⇒ Given the large number of patients and participating are subsequently admitted to the ICU or a similar high study sites the trial is highly depending on the com- dependency unit. The primary endpoint is the incidence pliance and accuracy of the involved sites which is a of AKI within 72 hours after surgery according to the limitation of the study. 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 syndrome is associated with adverse short- adverse kidney events (combined endpoint consisting of persistent renal dysfunction, RRT and mortality) at day 90. and long-­term outcomes, resulting in a major Further, we will evaluate preoperative and intraoperative healthcare burden worldwide.3–6 Although risk factors affecting the incidence of postoperative AKI. In the incidence varies depending on the an add-­on analysis, we will assess urinary biomarkers for patient population and type of surgery, AKI is early detection of AKI. now being considered as an independent risk Ethics and dissemination EPIS-­AKI has been approved factor for adverse outcomes such as chronic © Author(s) (or their by the leading Ethics Committee of the Medical Council kidney disease, chronic dialysis dependency, employer(s)) 2022. Re-­use North Rhine-­Westphalia, of the Westphalian Wilhelms-­ permitted under CC BY-­NC. No as well as higher mortality rates.7–9 Although University Münster and the corresponding Ethics major surgery is the second most common commercial re-­use. See rights Committee at each participating site. Results will be and permissions. Published by cause of AKI, there is a large variability in BMJ. disseminated widely and published in peer-­reviewed the reported incidences of surgery-­associated 1 journals, presented at conferences and used to design Department of Anaesthesiology, further AKI-­related trials. AKI.10 After abdominal surgery, the incidence Intensive Care and Pain Medicine, Universitätsklinikum Trial registration number NCT04165369. rate of AKI ranges from 1.8% to 39.3%.11–14 Münster, Münster, Germany Recent studies in cardiac surgery patients 2 Institute of Biostatistics and reported a broad range in the incidence of Clinical Research, University of INTRODUCTION AKI from 3.1% to 39.9%.15–18 After intro- Münster, Münster, Germany More than 300 million surgical procedures are ducing a uniform definition, results were Correspondence to performed each year and acute kidney injury thought to become comparable. Most of the Dr Alexander Zarbock; (AKI) is a common complication after major trials, though, are retrospective and therefore ​zarbock@​uni-​muenster.​de surgery with increasing incidence.1 2 This their message is limited due to the nature of Weiss R, et al. BMJ Open 2021;11:e055705. doi:10.1136/bmjopen-2021-055705 1 Open access BMJ Open: first published as 10.1136/bmjopen-2021-055705 on 30 December 2021. Downloaded from http://bmjopen.bmj.com/ on October 6, 2023 at Univesity Autonomous of Barcelona. the trial design. Additionally, AKI is mainly diagnosed by limited capabilities due to poverty, lack of education the serum creatinine criterion, whereas the urine output and limited access to healthcare and equipment, such as (UO) criterion is often disregarded. However, it has electronic health data and patient files,28–32 the numbers been shown in intensive care unit (ICU) patients as well of AKI cases and AKI-­associated complications, such as as in cardiac surgery patients that the urine criterion is mortality, are likely underestimated. important for diagnosing and staging AKI.19 20 As such, a Consequently, the exact incidence of AKI after major retrospective cohort study including 4229 patients under- surgery is currently unknown. going major non-­cardiac surgery showed an increase of Epidemiology of Surgery-­ associated Acute Kidney AKI from 8.1% to 64.0% when considering both serum Injury (EPIS-­AKI) is designed to prospectively evaluate creatinine and UO in contrast to serum creatinine alone.21 the global epidemiology of AKI after major surgery using Patients meeting both AKI-­criteria showed significantly the latest KDIGO consensus definition. Further, the trial higher mortality rates and need for renal replacement as aims at assessing preoperative and intraoperative risk compared with patients with AKI solely or predominantly associated with surgery-­associated AKI. diagnosed by one criterion.19 Furthermore, it could be demonstrated that patients diagnosed with AKI based Objectives and aims on UO had significantly longer ICU and hospital stays as Aim 1 compared with those patients with to serum creatinine-­ To prospectively evaluate the epidemiology of AKI within based AKI.22 72 hours (defined by the KDIGO criteria) after major Though research regarding AKI is performed nearly surgery that requires admission to an ICU or a similar worldwide, the vast majority of data derives from studies high dependency unit. conducted in high developed countries making it difficult Aim 2 to compare their results to data from low-­income/middle-­ To assess preoperative and intraoperative risk factors for income countries. Low-­income and middle-­income coun- the development of surgery-­associated AKI and evaluate tries often neither have the resources nor infrastructure modifiable risk factors. to conduct large prospective trials. Furthermore, data quality and study design are crucial points as most of the Protected by copyright. Aim 3 studies are conducted retrospectively, used different clas- We aim to evaluate and validate novel biomarkers for early sifications and lack standardisation. A meta-­analysis from detection of surgery-­associated AKI and to differentiate 2013 included 312 studies from 2004 to 2012 of which between transient (<48 hours) and persistent (>48 hours) only 154 adopted a Kidney Disease: Improving Global AKI in an add-­on analysis. Outcomes (KDIGO) equivalent AKI definition. This diversity underlines the difficulty. The pooled overall AKI rate in critically ill adult patients according to KDIGO METHODS AND ANALYSIS was 31.7%. However, the incidence in different regions Design and setting varied noteworthily: Northern Europe 14.7%, Western The EPIS-­AKI trial is an international prospective, obser- Europe 20.1%, Southern Europe 31.5%, Northern vational, multicentre, cohort study conducted at more America 24.5%, Southern America 29.6%, Western Asia than 90 centres across the world (online supplemental 16,7%, Eastern Asia 14.7%. While the vast majority of table 1). The final version of the participating centres will included patients derived from high-­ income countries be attached to the final report of the clinical trial. (ie, approximately 1.9 million from North America and The protocol follows the principles of ‘Strengthening Europe), only 3000 subjects from South America could be the Reporting of Observational Studies in Epidemiology’ included. Nevertheless it could be demonstrated that the (STROBE) and the Declaration of Helsinki (version AKI-­associated mortality was inversely related to income Fortaleza 2013). The flow chart is summarised in figure 1. of countries and percentage of gross domestic product spent on total health expenditure.23 Another systemic Patient and public involvement review and meta-­ analysis from 2020 considering criti- EPIS-­AKI is an investigator initiated observational trial cally ill patients presented similar results. Although AKI that was designed by investigators of the Department incidences were similar between developed (38 studies, for Anesthesiology, Intensive Care and Pain Medicine at 39.3%) and developing countries (18 studies, 35.1%), the University Hospital Münster. No other institutions patients in the latter had worse outcomes regarding ICU nor patients were involved in the trial design. However, stay, need for dialysis and mortality.24 patients will be asked for their participation in this trial Considering recent studies from Germany and else- to collect corresponding data (see the Consent process where, 57%–75.6% of AKI cases go undetected, undiag- section). Furthermore, national coordinators and nosed and/or undocumented.25–27 This demonstrates different societies (box 1) helped to promote the study in that AKI seems not to receive adequate recognition or their respective countries and to translate prepared docu- attention even in high developed countries. Given the ments into several languages. Especially, the European fact that many regions in low-­ income/middle-­ income Society of Anesthesiology and Intensive Care provided countries additionally suffer from lower living conditions, support in recruiting national coordinators. Study results 2 Weiss R, et al. BMJ Open 2021;11:e055705. doi:10.1136/bmjopen-2021-055705 Open access BMJ Open: first published as 10.1136/bmjopen-2021-055705 on 30 December 2021. Downloaded from http://bmjopen.bmj.com/ on October 6, 2023 at Univesity Autonomous of Barcelona. Box 1 Supporting societies Name of participating societies Colegio Mexicano de Medicina Crítica Colombian Association of Surgery Czech Society of Anesthesiology and Intensive Care Deutsche Gesellschaft für Anästhesiologie und Intensivmedizin European Society of Anaesthesiology and Intensive Care Korean Society of Anesthesiologists Società Italiana di Anestesia Analgesia Rianimazione e Terapia Intensiva Société Française d'Anesthésie et de Réanimation South African Society of Anaesthesiologists Spanish Perioperative Audit and Research Network Turkish Anaesthesiology and Reanimation Society be considered (including elective and emergency surgery) as long as patients fulfil all the inclusion and none of the exclusion criteria. Due to the nature of the surgical proce- dures, some specialties will be more present than others. Therefore, subgroup analyses will be performed to focus on the incidence of AKI in different specialties. In addition, in selected centres, urine samples will be collected immedi- Figure 1 EPIS-­AKI Trial Workflow Research coordinators ately after surgery from routinely placed urinary catheters. will screen patients for eligibility on a daily basis and then We expect an evenly distributed sex ratio. No patient ask patients for study participation. After surgery, inclusion/ will be excluded from the study based on sex, ethnicity Protected by copyright. exclusion criteria will be rechecked and if still eligible or religion. Sex will be used for covariate adjustment in a (especially duration of surgery ≥2 hours, admission to ICU multivariate data analysis. or similar), patients will be enrolled and included in the trial. All subjects will be treated according to the standards Consent process of the local centres. Patients will be monitored closely for Country-­specific requirements, including ethics approval the first postoperative 72 hours during their stay on a high and/or study registration at local authorities, have to be dependency unit. In addition, in selected study sites urine fulfilled prior to starting patient enrolment. All patients samples will be collected directly from the routinely inserted urine catheter immediately after surgery. AKI, acute kidney will be approached and informed before participation, injury; EPIS-­AKI, Epidemiology of Surgery-­associated Acute usually during their anaesthesia previsit, and will be asked Kidney Injury; ICU, intensive care unit, PACU; post anesthesia to give written informed consent according to local regu- care unit, MAKE90; major adverse kidney events at day 90. lations. This is a two-­step process. After surgery has been performed, patients have to be finally proven for eligi- bility according to study criteria. Participation in this trial will be published in a peer-­reviewed journal. At request, is voluntary. All patients will receive standard periopera- patients and/or their representatives will be informed tive care. None of the patients is exposed to additional about the results of the trial. risks. All data will be kept confidential and stored in a pseudonymised form. The patient has the right to with- Participants draw from the study at any time without providing a All adult patients (age ≥18 years) undergoing major surgery reason and without medical treatment being affected. for at least 2 hours and who are admitted to an ICU or a similar high dependency unit will be asked for study partic- Observation ipation and will be included in this trial. Subjects who fulfil All included patients will be treated according to the one of the exclusion criteria ((1) pre-­ existing AKI, (2) standard of care at each participating site. Patients will AKI within last 3 months, (3) end-­stage renal disease with be closely monitored for the first 72 hours after surgery dialysis dependency and (4) kidney transplant) will not be and during ICU stay. This time period will give the possi- included. Two major inclusion criteria were chosen (major bility to distinguish between rapid recovery (<48 hours) surgery defined as surgery >2 hours plus a subsequent ICU and persistent AKI (>48 hours). Data regarding routine admission) to exclude patients undergoing minor surgeries clinical management will be collected, especially data on the one hand and to exclude revision surgeries of criti- regarding demographics, comorbidities, type of surgical cally ill patients on the other hand. The combination of the procedure, complications and administered medication duration of surgery and the subsequent admission to an ICU (table 1). Furthermore, AKI stages will be documented is the important component to only include patients at risk. according to KDIGO criteria and assessed by serum-­ All surgical patients independent of surgical specialty may creatinine (SCr) and UO. Once the inlaying urine Weiss R, et al. BMJ Open 2021;11:e055705. doi:10.1136/bmjopen-2021-055705 3 Open access BMJ Open: first published as 10.1136/bmjopen-2021-055705 on 30 December 2021. Downloaded from http://bmjopen.bmj.com/ on October 6, 2023 at Univesity Autonomous of Barcelona. Table 1 Collected data and information Preoperative Patient data Medical history medication Intraoperative data Postoperative data Outcomes Follow-­up Age Hypertension Aspirin (ASA/ Surgical specialty Start/end of documentation Date of ICU discharge Date of ASS) follow-­up Gender Atrial fibrillation/flutter ACE inhibitors or Type of surgery APACHE II score Date of hospital discharge Patient ARBs condition Ethnicity Previous myocardial Beta-­blockers Surgical procedure as SAPS score Condition of hospital RRT infarction listed by ICHI discharge (alive/death) Height Congestive heart failure Diuretics Duration of surgery Fluid intake (crystalloids, Date of death SCr level according to NYHA colloids, blood products) classification Weight Diabetes NSAIDs Total time of Fluid output (total blood loss, SCr level at ICU discharge   (except ASA/ cardiopulmonary bypass urinary output) and hospital discharge ASS) SCr baseline Chronic obstructive Statins Total X-­Clamp time Removal of urine catheter RRT at hospital discharge   disease Date of Chronic kidney disease Vasopressors Fluid intake (crystalloids, Application of vasopressors Days of RRT in hospital   hospital (Stages) colloids, blood products) admission Date of Peripheral vascular Use of contrast Fluid output (total blood Application of nephrotoxic     surgery disease media on week loss, urinary output) agents prior to surgery Date of ICU Previous stroke   Episodes of hypotension Application of diuretics     admission (MAP <55 mm Hg for more than 5 min)   ASA Score   Application of Postoperative complications     vasopressors       Application of AKI according to KDIGO     Protected by copyright. nephrotoxic agents classification       Application of diuretics Severity of AKI           Intraoperative Occurence of AKI     complications         Duration of AKI     (transient <48 hour vs Persistent >48 hour)         Diagnosis (worst case AKI)     via SCr, UO, both         RRT             Start of RRT             Modality of RRT at initiation             Indication for RRT     ACE, Angiotensin converting enzyme inhibitors; AKI, acute kidney injury; APACHE, Acute physiology and chronic health evaluation; ARBs, angiotensin-­receptor blockers; ASA, American Society of Anesthesiologists; ASA/ASS, acetylsalicylic acid; ICHI, International classification of health interventions; ICU, intensive care unit; KDIGO, Kidney Disease: Improving Global Outcomes; MAP, Mean arterial pressure; NSAID, Nonsteroidal anti-­inflammatory drugs; NYHA, New York Heart Association; RRT, renal replacement therapy; RRT, Renal replacement therapy; SAPS, Simplified acute physiology score; SCr, Serum-­creatinine; UO, Urine output; UO, urine output . catheter is removed, the urine criterion will no longer be Kidney Disease: Improving Global Outcomes 2 used to diagnose and stage an AKI. SCr: 2–2.9 times baseline within 7 days. After 90 days, a follow-­up will be performed by telephone UO:<0.5 mL/kg/hour for ≥12 hours. call contacting the patient or the general practitioner. Kidney Disease: Improving Global Outcomes 3 Outcomes SCr:≥4.0 mg/dL (353.60 µmol/L) or ≥3 times baseline The primary outcome of the trial is the incidence of within 7 days. AKI within the first 72 hours after surgery according to UO:<0.3 mL/kg/hour for ≥24 hours or anuria KDIGO criteria (including the distribution of stages): for ≥12 hours. The secondary outcomes include: Kidney Disease: Improving Global Outcomes 1 ► Use of renal replacement therapy. SCr: ≥0.3 mg/dL (26.52 µmol/L) within 48 hours or ► Length of ICU stay 1.5–1.9 times baseline within 7 days. ► Length of hospital stay. UO:<0.5 mL/kg/hour for 6–12 hours. ► Transient (<48 hours) vs persistent (>48 hours) AKI. 4 Weiss R, et al. BMJ Open 2021;11:e055705. doi:10.1136/bmjopen-2021-055705 Open access BMJ Open: first published as 10.1136/bmjopen-2021-055705 on 30 December 2021. Downloaded from http://bmjopen.bmj.com/ on October 6, 2023 at Univesity Autonomous of Barcelona. ► Renal recovery (SCr value within the <1.5 times range We aim for a high quality, prospective, large-­ scale, of the baseline SCr at day 90). multi-­centre, observational trial to estimate the incidence ► Survival of post-­surgery AKI (primary aim) with high precision. – ICU mortality. That is, to obtain a small width of the corresponding – Hospital mortality. 95% (Clopper-­Pearson) CI. The width of the Clopper-­ ► Major adverse kidney events at day 90 (MAKE90): Pearson CI for a proportion increases (ie, the precision combined endpoint consisting of decreases) the closer the incidence of surgery-­associated – Mortality. AKI is to 50%. Assuming that the incidence of surgery-­ – Renal replacement therapy. associated AKI does not exceed 40% (which is in line with – Persistent renal dysfunction defined as SCr≥1.5 the previous reported rates), we calculated the width of times as compared with baseline SCr. the CI under the worst-­case scenario (ie, scenario with maximum CI width/lowest precision). This is realised, if Furthermore, secondary analyses will be performed for the incidence of surgery-­associated AKI is at the very top ► Effect of preoperative risk factors on the incidence of of the reported rates (ie, 40%). The precision will be as postoperative AKI. calculated, if the incidence of surgery-­associated AKI is ► Effect of predetermined intraoperative factors on the 40%, or higher, if the incidence is less than 40%. Using incidence of postoperative AKI. this approach, the width of the CI based on a sample ► Predictive value of different AKI biomarkers (urine size of n=10 000 patients and a confidence level of 95% for this endpoint will be collected in some centres). is given by 0.019. Thus, with n=10 000 patients, the inci- dence of surgery-­associated AKI can be estimated with at Data collection least this precision. Clinical data will be collected from the patient charts of The study also aims to detect factors that might be each participating site in an electronic case report form correlated to the occurrence of surgery-­associated AKI, (eCRF) (Research Electronic Data Capture, V.10.6.22, as for example, the type of surgery, age, country income respectively up-­to-­date version, Vanderbilt University) in and predefined preoperative/intraoperative factors. a pseudonymised form. Patient identifiable information Therefore, further exploratory analyses such as univari- Protected by copyright. will not be available for data-­analysis. Investigators will be able and multivariable logistic regression analyses will given secure login credentials (username and password). be conducted. Given the fact that the study does neither Data transmission and storage of web-­based information include interventions nor additional risks for patients is encrypted and will be stored and backed up at the West- but there is a relatively large number of different types falian Wilhelms University of Münster. of surgeries, a sample size of n=10 000 patients is reason- able to investigate the influence of this parameters on the Data quality occurrence of surgery-­associated AKI in a univariable and Each study team will be instructed on how to use the multivariable context. data entry system and how to interpret the protocol. A frequently asked questions summary describing crucial Biomarker samples parts of the trial is handed out to the participating sites. To further investigate and compare the performance of Furthermore, every team has to be guided by at least one biomarkers to predict surgery-­associated AKI in a clinical local qualified doctor to ensure medical understanding. background urine samples are collected in selected study The current KDIGO criteria are also included and centres as an add-­on study. We will measure common displayed in the eCRF to make it as easy and reliably as new biomarkers as tissue inhibitor of metalloprotein- possible for the onsite staff to classify AKI stages. ases 2 and insulin like growth factor binding protein 7 However, each team will be provided an emergency ([TIMP2]*[IGFBP7]), kidney injury molecule-­1 (KIM-­1), contact number and mail address to ask for help neutrophil gelatinase associated lipocalin (NGAL), fatty-­ regarding medical, technical or protocolary issues. The acid-­binding protein (FABP-­1), C-­C chemokine ligand 14 study organising team will offer rapid support throughout (CCL14) and assess whether the biomarkers can predict the entire study period. Furthermore, protocol and study the development of an AKI ([TIMP2]*[IGFBP7], KIM-­1, materials are translated into common languages to facil- NGAL, FABP-­1) or syndrome progression (CCL14). This itate processes and to avoid uncertainties. Close contact will help to better understand biomarker kinetics, to eval- will be held especially to national coordinators as well as uate their significance and demonstrate their relation to each single study site on a routinely manner, enabling to AKI development. Parameters will be determined by participants to resolve any unclarities straightforwardly, using commercially available assays prepared according rapidly and directly with the organising study team. This to the respective manufactures protocol. will ensure collaborators are able to collect accurate data. Statistical analysis Sample size Calculations are carried out in cooperation with the Depending on the type of surgery, AKI incidences of local Institute of Biostatistics and Clinical Research and 1.8%–39.3% are reported in existing literature. are intended to answer the question of the research Weiss R, et al. BMJ Open 2021;11:e055705. doi:10.1136/bmjopen-2021-055705 5 Open access BMJ Open: first published as 10.1136/bmjopen-2021-055705 on 30 December 2021. Downloaded from http://bmjopen.bmj.com/ on October 6, 2023 at Univesity Autonomous of Barcelona. project and to provide scientific evidence using statistical CONCLUSION methods. Statistical analyses will be performed according The EPIS-­AKI trial is a large international observational to the principles of the International Council for trial with the aim to investigate the epidemiology of Harmonisation of Technical Requirements for Pharma- surgery-­associated AKI. Currently, there is a large vari- ceuticals for Human Use (ICH)-­guideline E9 ‘Statistical ability in the reported rates of AKI after major surgery. Principles for Clinical Trials’ using standard statistical After abdominal surgery, the incidence of AKI ranges software. from 1.8% to 39.3%.11–14 Recent published studies in Data will be summarised by standard descriptive statis- cardiac surgery demonstrated a range in the incidence tical measures. Normally distributed variables will be of AKI from 3.1% to 39.9%.15–18 In a surgical critical care reported as mean and SD and non-­normally distributed setting, the incidence rate was reported to be 53.2%.30 variables as median and lower and upper quartile. Cate- These variabilities are in part a result of the different gorical variables will be expressed as proportion. For definitions used for diagnosing AKI. On the other hand, primary and secondary outcomes point estimates and there is a large number of unreported AKIs meaning that 95% CIs will be given. Data presentation will follow the the actual incidence of AKI may even be higher.23–26 Since STROBE guideline. AKI is independently associated with adverse outcomes, an In the primary statistical analysis, the incidence of AKI exact knowledge of the incidence is imperatively needed will be estimated together with the exact corresponding to enhance the awareness for this critical syndrome and two-­sided 95% CI according to Clopper-­ Pearson. The consequently optimise patient management in order prespecified secondary outcomes will be evaluated to improve patient outcomes. The EPIS-­AKI trial is the first large international observational trial focusing on based on descriptive statistics, point estimates and corre- surgery-­associated AKI defined by the KDIGO criteria. sponding 95% CIs. The results of this trial will enhance the awareness for this In order to evaluate the impact of factors that might be critical condition and is ultimately needed to design new correlated to the occurrence of surgery-­associated AKI, trials that focus on prevention and management of AKI. as for example, the type of surgery (ie, cardiac, ortho- paedic, etc), preoperative and intraoperative factors (eg, Acknowledgements The authors would like to thank all participating centres Protected by copyright. length of surgery, use of blood products, morbidities), and their investigators as well as assisting societies, especially the ESAIC, for their and country income group, univariable and multivariable continuous support and work. logistic regression analyses will be conducted. Further- Collaborators Hichem Makhloufi, Anis Cherak,Lamine Lakhel Ghanem, Zohier more, the ability of novel biomarkers to predict the occur- Gouaglia, Dina Nasrine Guadouri, Fayrouz Naouel Hama, Mustafa Kara, Omayma Saadi (Constantine, Algeria, Constantine Centre Hospitalier Universitaire, rence of surgery-­ associated AKI will be assessed using Department of Anesthesiology and Resuscitation); Rachida Sakhraoui, Fadila logistic regression analyses. Results from logistic regres- Bourou, Abdelhadi Cherifi, Rahmoune Ghania Sadaoui (Alger, Algeria, Etablissement sion analyses will be presented as ORs, corresponding Hospitalier Spécialisé Salim Zemirli El Harrach, Department of Anesthesiology and Resuscitation); Amel Ouyahia (Sétif, Algeria, Saadna Abdenour Teaching Hospital, 95% CIs and p values. Department of Anesthesia); Ilhem Ouahab, Souad Bouaoud, Meriem Abdoun (Sétif, To quantify evidence of differences between groups Algeria, University Hospital of Sétif, Department of Epidemiology, Department of given by categorical parameters, such as the type of General Surgery); Anisse Tidjane, Benali Tabeti, Nabil Boudjenan-­Serradj (Oran, surgery, statistical tests like t-­tests, Mann-­Whitney-­U tests, Algeria, University Hospital 1st November 1954, Department of General Surgery); Carlos Jose Pérez Rivera, Paulo Cabrer, Julián Corso, Juan Pablo García, Sharon χ2 tests or Fisher’s exact tests will be used appropriate to Idarraga, Christopher Montoya (Bogotá, Colombia, Universidad El Bosque, the distributional characteristics of the endpoint. Fundación Cardioinfantil, Clinical Research Coordinator, Department of General Additionally, subgroup analyses will be performed Surgery); Rafael Figueroa, Eduar Aldana, María Alejandra Torrado (Ibagué, Colombia, based on the type of surgery (elective vs emergency Avidanti Clinic Ibaqué, Department of Anesthesiology); Ke Peng, Zheng-­min Ma, Yu-­fan Yang, Ya-­juan Zhu (Jiangsu, China, First Affiliated Hospital of Soochow surgery; surgical specialty). University, Department of Anesthesiology); Peter Sklienka, Michal Frelich, Vojtech All inferential statistics are intended to be explor- Jarkulis, Pavel Sevcik, Vojtech Vodicka (Ostrava, Czech Republic, University Hospital atory (ie, hypothesis generating) and will be interpreted Ostrava, Department of Anesthesia and Intensive Care); Mohamed Gamal Elbahnasawy, Shady Elsalhawy, Sara Motawea, Zeinab Othman, Mohamed Sahma accordingly. A two-­ sided p <0.05 will be considered as (Tanta, Egypt, Tanta University Faculty of Medicine, Department for Emergency statistically noticeably. medicine and traumatology); Ahmed Mahmoud Nafea (Alexandria, Egypt, Alexandria University Main Hospital, Department of Anesthesiology); Nermin Ahmed, Doaa Ali Attia (Alexandria, Egypt, Alexandria University, Medical Research Institute); Moataz Ethics and dissemination Maher Emara,Mohamed Mamdouh Bonna, Mohamed Ahmed Gabr, Amany Ismail EPIS-­AKI has been approved by the leading Ethics Tarbay (Mansoura, Egypt, Mansoura University, Faculty of Medicine, Liver Transplant Committee of the Medical Council North Rhine-­ - Gastrointestinal Surgical Center, Department of Anesthesiology and Intensive Westphalia and of the Westphalian Wilhelms-­University Care); Ibrahim Abdelmonaem Abdehaleem, Esraa Elsayed Mohamed, Amr Mahmoud Eldeeb (Sharkia, Egypt, Zagazig University Hospital, Department of Anesthesiology); Münster (2019-­ 424 f-­ S) and the corresponding Ethics Ahmed Mohamed Abbas, John Ashraf Magdy, Zyad Hassan Hamed, Hany Mostafa Committee at each participating site. The results will Esmaeil Osman, Mostafa Samy Abbas (Assiut, Egypt, Assiut University Hospitals, be presented at national as well as international confer- Department of Anesthesia and Intensive Care); Oliver Joannes-­Boyau, Nicolas Barraud, Corentin Berthelot, Thibault Camus, Anissa Dahmi, Mylène Defaye, ences. The final manuscript will be published in a peer-­ Sébastien Derville, Younes El-­Boustani, Elsa Deloge, Hélène Jacob, Simon Monziols, reviewed journal and results will be used to design further Fred Priem, Jean-­Jacques Robin (Bordeaux, France, Centre Hospitalier Universitaire AKI related studies. de Bordeaux, Department of Anesthesiology and Intensive Care); Vincent Legros, 6 Weiss R, et al. BMJ Open 2021;11:e055705. doi:10.1136/bmjopen-2021-055705 Open access BMJ Open: first published as 10.1136/bmjopen-2021-055705 on 30 December 2021. Downloaded from http://bmjopen.bmj.com/ on October 6, 2023 at Univesity Autonomous of Barcelona. Therry Floch, Salvatore Muccio (Reims, France, Centre Hospitalier Universitaire de (Münster, Germany, Herz-­Jesu-­Krankenhaus, Department of Anesthesiology and Reims, Hôpital Maison Blanche, Surgical Intensive Care Unit); Claire Geneve, Marie Intensive Care); Matthias Boschin, Christian Sengelhoff (Sendenhorst, Germany, St. Lim Legouge, Stéphanie Tao Mauny, Willy Mfam, Léa Pascot (Orléans, France, Josef-­Stift Sendenhorst, Department of Anesthesiology and Intensive Care); Ulrich Centre Hospitalier Universitaire de Orléans, Department of Anesthesiology and Michael Göbel, Jan Gerrit Haaker, Carina-­Kristin Göttker, Matthias Gründel (Münster, Critical Care Medicine); Christophe Aveline, Mireille Chartier, Benjamin Duteurtre, Germany, Sankt Franziskus Hospital, Department of Anesthesiology and Intensive Jean Francois Gautier, Aidren Le Cousin, Pierre Vautier (Cesson-­Sévigné, France, Care); Matthias Heringlake, Romina Baumgärtel, Astrid Berggren, Madeleine Hôpital Privé Sévigné, Department of Anesthesiology and Critical Care Medicine); Gülzow, Lennart Muras, Hauke Paarmann (Karlsburg, Germany, Hospital Karlsburg, Julien Nadaud, Nathalie Begel, Claire-­Annissa Chekirine, Vincent Derlon, Elodie Department of Anesthesiology and Intensive Care); Serge Thal, Alexander Bentley, Grein, Marie-­Annick Lehair, Laurent Magazzeni, Philippe Magazzeni, Carsten Potter, Dschamil El-­Masri, Anne Sebastiani (Wuppertal, Germany, University Witten/ Catherine Roth, Florence Voivret (Vantoux, France, Hôpital Robert Schuman-­Groupe Herdecke, Helios University Hospital Wuppertal, Department of Anesthesiology and UNEOS, Department of Anesthesiology and Critical Care Medicine); Thomas Intensive Care); Eleni Arnaoutoglou, Maria Ntalouka (Larissa, Greece, University of Rimmelé, Valérie Cerro (Lyon, France, Hôpital Edouard Herriot, Department of Thessaly, University Hospital Larissa, Department of Anesthesiology); Paula Anesthesiology and Critical Care Medicine); Stéphanie Suria, Jamil Elmawieh, Stratigopoulou, Anastasia Analytis, Efthymios Mavrommatis (Athens, Greece, Laiko Annabelle Stoclin (Villejuif, France, Gustave Roussy Cancer Center, Postoperative General Hospital of Athens, Department of Anesthesiology); Petros Tzimas, Agathi Intensive Care Unit); Cédric Cirenei, Gregoire Andrieu, Sven Couloumy, Jeremy Karakosta, Danai Pantazi (Ioannina, Greece, University of Ioannina, University Falcone, Marion Fajardy, Arsène Gagneuil, Emeline Girardet, Agnès Mazereeuw Hospital Ioannina, Department of Anesthesiology); Antonia Dimakopoulou, Katerina (Lille, France, Centre Hospitalier Universitaire de Lille, Hôpital Huriez, Department of Dimitropoulou (Athens, Greece, ‘G. Gennimatas’ General Hospital of Athens, Anesthesiology and Intensive Care); Sébastien Ponsonnard (Limoges, France, Department of Anesthesiology); Orestis Ioannidis (Thessaloniki, Greece, General Polyclinique de Limoges, Clinique François Chénieux, Department of Anesthesiology Hospital G. Papanikolaou, Department of General Surgery of A.U.TH); Humam and Intensive Care); Pierre-­Yves Egreteau, Mélanie Bertel, Simon Bocher, Vanessa Jalaawiy (Al-­Diwaniyah, Iraq, Al-­Diwaniyah Hospital, Department of General Carn, Lenaïg Le Guen, Guillaume Le Loup, Montaine Lefevre (Morlaix, France, Surgery); Aeshah Anwar (Bagdad, Iraq, Bagdad Medical City Hospital, Department of Centre Hospitalier des Pays de Morlaix, Department of Intensive Care Medicine); General Surgery); Hashim Talib Hashim (Thi Qar, Iraq, Al-­Nassiryah Teaching Carole Ichai, Amanita Diop (Nice, France, Centre Hospitalier Universitaire de Nice Hospital); Hogir Imad Rasheed Aldawoody (Khanaqeen, Iraq, Khanaqeen General Hôpital Pasteur 2, Department of Intensive Care Medicine); Vanessa Jean-­Michel, Hospital, Department of General Surgery); Andrea Cortegiani, Giulia Catalisano, Gilia Sylvie Devlieger, Juliette Duthoit, Mohamed El Kadiri (Tourcoing, France, Centre Ingoglia, Mariachiara Ippolito (Palermo, Italy University of Palermo, Policlinico Paolo Hospitalier Dron Tourcoing, Department of Intensive Care Medicine); Maxime Léger, Giaccone, Department of Anesthesia and Intensive Care); Silvia De Rosa, Lucia Viviane Cassisa, Sigismond Lasocki, Charline Masson, Emmanuel Rineau (Angers, Cattin (Vicenza, Italy, Vicenza Hospital, Department of Anesthesia and Intensive France, Centre Hospitalier Universitaire d'Angers, Department of Anesthesiology and Care, International Renal Research Institute of Vicenza (IRRIV)); Andrea Bianchin, Intensive Care); Pierre Verrier, Axel Coquerel (Caen, France, Centre François Marisa Barone (Montebelluna, Italy, Montebelluna City Hospital, Department of Baclesse, Postoperative Intensive Care Unit); Philippe Montravers, Enora Atchade Anesthesia and Intensive Care); Gianluca Paternoster (Potenta, Italy, San Carlo (Paris, France, Hôpital Bichat, Department of Anaesthesiology and Surgical Intensive Regional Hospital, Department of Anesthesia and Intensive Care, Branch Care); Charles-­Edouard Rochon, Céline Delerue (Blois, France, Centre Hospitalier Cardioanesthesia); Salvatore Lucio Cutuli, Andrea Russo, Liliana Sollazzi, Laura Protected by copyright. Simone Veil de Blois, Department of Anesthesiology and Intensive Care); Vidal Cascarano, Massimo Antonelli, Paola Aceto, Bruno Romanò (Rome, Italy, Gemelli Quentin, Vanessa Latry (Tarbes, France, Centre Hospitalier de Bigorre, Department University General Hospital, Department of Anesthesia, Intensive Care and of Anesthesiology and Critical Care Medicine); Nina Queixalos, Vincent Cottenceau Emergency Medicine); Savino Spadaro (Ferrara, Italy, University of Ferrara, Faculty (Centre Hospitalier Universitaire de Bordeaux, Site Pellegrin, Surgical and of Medicine, Department Morphology, Surgery and Experimental Medicine); Traumatologic Intensive Care); Thierry Braun, Saad Bouzoubaa, Basile Christ, Vincenzo Francesco Tripodi, Michele Rossi, Rosamaria Scappatura, Maria Cristina Audrey Geiger, Joachim Gomille, Vianney Kieffer, Simone Mangeant, Christelle Vadalà (Calabria, Italy, Great Metropolitan Hospital "Bianchi-­Melacrino-­Morelli", Prochilo, Christian Schmitt, Stefan Skwirba (Strasbourg, France, Clinique Sainte Department of Anesthesia and Intensive Care, Branch Cardioanesthesia); Diego Anne, Department of Anesthesiology and Intensive Care); Hubert Grand, Frédérique Fiume (Rome, Italy, Sant'Eugenio Hospital, Department of Anesthesia and Intensive Boury (Libourne, France, Centre Hospitalier Libourne, Department of Intensive Care); Care); Maria Teresa Strano, Giulia Oddo (Palermo, Italy, Public Hospital Cristina Nicolas Mayeur, Marie Pasquie (Toulouse, France, Clinique Pasteur, Cardiovascular Benfratelli, Department of Anesthesia and Intensive Care); Clemente Santorsola and Thoracic Surgery Unit and Intensive Care Unit); Pierre Garçon (Jossigny, France (Esine, Italy, General Hospital Vallecamonica-­Sebino ASL Vallecamonica-­Sebino, Centre Hospitalier de Marne-­La-­Vallée, Intensive Care Unit); Vincent Bruckert, Department of Anesthesia, Intensive Care and Emergency Medicine); Bilal Abu Vincent Arnould, Mona Bonciu, Thibault Chapelle, Luc Facchino, Florence Hussain, Adnan Raed Alnaser, Anas Hassouneh Ghassan, Khaled Hasanein, Fagot-­Gandet, Andrea Iachim, Elena Mannu, Olivier Perus, Rémi Plattier, Romain Mohammed Theab (Amman, Jordan, Al-­Basheer Hospital, Amman, Departmet of Rozier (Nice, France, Centre Hospitalier Universitaire de Nice, Department of Surgery); Seokyung Shin, Seungho Jung, Kyuho Lee (Seoul, Korea, Yonsei University Anesthesiology and Intensive Care); Gaël Pradel, Michel Boudinaud, Marie-­Hélène College of Medicine, Department of Anesthesiology and Pain Medicine); Sung Mee Hausermann, My Hue Nguyen (Aurillac, France, Centre Hospitalier Henri Mondor Jung, Jongyoon Baek (Daegu, Korea, Yeungnam University School of Medicine, d'Aurillac, Department of Intensive Care Medicine); Andersen Ramorasata, Amélie University Hospital Yeungnam, Department of Anesthesiology and Pain Medicine); Barreau, Anne-­Hélène Boivin (Mont de Marsan, France, Centre Hospitalier Mont de Muhammed K. Elhadi (Tripoli, Libya, University of Tripoli, Faculty of Medicine); Wafa Marsan, Department of Anesthesiology and Intensive Care); Céline Ravry (Dax, Wafa O.Aldressi, Issa Abuzeid, Mohammed Albaraesi, Sarah Aldressi (Benghazi, France, Centre Hospitalier de Dax, Department of Anesthesiology and Intensive Libya Benghazi Medical Center, Departmet of General Surgery); Wegdan Khalel, Care); Nicolas Mottard, Johanne Beuvelot, Florence Prunier Bossion, Olivier Eman Abdulwahed, Akram Abdulhamid Ashur Abujrad, Amer Almaghrabi, Muhand Desebbe (Lyon, France, Clinique de la Sauvegarde, Department of Anesthesiology Mohammed Alteleeb, Entisar Ahmed Ali Alshareea, Marwa Isa Biala, Abdulqudus and Critical Care); Alexander Zarbock, Christian Dörr, Thilo Caspar von Groote, Mira Deeknah, Dooua Ali Gheddim, Reem Ghmagh, Nawras Salih Ali Abu Ikhrays, Marwa Küllmar, Christina Massoth, Melanie Meersch, Khaschayar Saadat-­Gilani, Raphael Sinan (Tripoli, Libya, Tripoli Central Hospital, Department of Anesthesiology); Enas Weiss, Carola Wempe (Münster, Germany, University Hospital Münster, Department Soula, Sumayyah Ghayth Bahroun, Khawla Derwish, Aya Munir Mohamed, Eman of Anesthesiology, Intensive Care and Pain Medicine); Sebastian Ziemann, Linda Sayed Younes (Sabratha, Libya, National Cancer Institute); Rayet Al Islam Benjouira, Grüßer, Ana Kowark, Pia Wittig (Aachen, Germany, University Hospital RWTH Aachen, Mohamed Aliwa, Najwa Abdullah Altashani, Mohammed Omar Alteb (Tripoli, Libya, Department of Anesthesiology and Intensive Care); Timo Brandenburger, Thomas National Heart Center Tripoli, Department of Anesthesiology); Ahmed Msherghi, Dimski, Niklas Döhmen, Laura Huthmann, Daniela Kaierle, Claude Pelletier, Manon Fatima Alagelli, Sufyan Albarouni, Ahmed Albishti, Sarah Aljamal, Mohamed Alsori, Schleß (Düsseldorf, Germany, University Hospital Düsseldorf, Department of Taha Ekhuja, Suha Elzwai, Mohammed Ghula, Tahani Mustafa, Ahmed Tuwaib, Haifa Anesthesiology and Intensive Care); Andreas Hohn, Sebastian Cleophas, Stephanie Zriba (Tripoli, Libya, University Hospital Tripoli, Department of Anesthesiology); Haunhorst, Marina Jansen, Alexandra Schmitt, Julia Soisch, Kilian Sturm Hamza Mahmoud Agilla (Tripoli, Libya, AboSleem Hospital, Department of (Mönchengladbach, Germany, Kliniken Maria Hilf Mönchengladbach, Department of Anesthesiology and Intensive Care); Toky Andriamahefa Rafanomezantsoa Anesthesiology and Intensive Care); Peter Rosenberger, Alexander Bendig, Lena (Toamasina, Madagascar Centre Hospitalier Universitaire de Analankininina Flohr, Helene Häberle, Pascal Hofmann, Jonathan Kuhle, Nora Michaela Leser, Toamasina, Department of Anesthesiology); Anne Marie Camilleri Podesta, Denise Kathrin Pfister, Stefanie Prohaska, Franziska Sennholz, Lena Stetz, Kathrin Weber Mifsud Bonnici, Tiziana Pirotta (Msida, Malta, University of Malta, Mater Dei (Tübingen, Germany, University Hospital Tübingen, Department of Anesthesiology Hospital, Department of Anesthesiology and Intensive Care); Gilberto Adrián Gasca and Intensive Care); Sebastian Stehr (Leipzig, Germany, University Hospital Leipzig, López (Ixtapaluca, Mexik, Regional Hospital of High Specialty of Ixtapaluca, Department of Anesthesiology and Intensive Care); Stephan Klaus, Marco Sadlo Department of Anesthesiology); Maja Mojsova Mijovska, Tatjana Davitkovska, Weiss R, et al. BMJ Open 2021;11:e055705. doi:10.1136/bmjopen-2021-055705 7 Open access BMJ Open: first published as 10.1136/bmjopen-2021-055705 on 30 December 2021. Downloaded from http://bmjopen.bmj.com/ on October 6, 2023 at Univesity Autonomous of Barcelona. Aleksandra Gavrilovska, Sanja Lukikj, Marija Vesova, Dina Zafirova (Skopje, North Department of Anesthesia); Orhan Sungur Mukadder, Demet Altun, Nur Canbolat, Macedonia, University Hospital Skopje Mother Theresa, Department for Anesthesia Müşerref Beril Dinçer, Tulay Özkan Seyhan (Istanbul, Turkey, Istanbul University, Reanimation and Intensive Care); Sarah Amro (Hebron, Palestine Princess Alia Istanbul Faculty of Medicine, Department of Anesthesiology); Serap Aktaş Yıldırım Governmental Hospital, Department of Anesthesiology); Baraa N. F. Hajjaj, Muawia (Istanbul, Turkey, Acıbadem Altunizade Hospital, Department of Anesthesiology); Alkhazendar, Yousuf Barakat, Sewar Abdulaziz Elejla, Ahmed Elhissi, Ahmed Khader, Müzeyyen İyigün (Istanbul, Turkey, Acibadem Atakent Hospital, Department of Ali Salem (Gaza, Palestine, Palestinian Ministry of Health - Al-­Shifa Medical Anesthesiology); Davut Yapıcı, Levent Özdemir, Aslinur Sagun (Mersin University, Complex, Department of Anesthesiology); Rita de Freitas Regufe,André Filipe de School of Medicine, Department of Anesthesiology and Intensive Care); Neval Oliveira Eloy, Lisbete Marisa Neto Cordeiro Perdigão (Setúbal, Portugal, Central Boztug, Yesim Cetintas, Bora Dinc, Emel Gündüz (Antalya, Turkey, University Hospital Hosptial de Setúbal, Department for Anesthesiology); Evgeny Grigoriev, Artem Ivkin, Akdeniz, Department of Anesthesiology); Hakkı Ünlügenç, Demet Lafli Tunay (Adana, Roman Kornelyuk (Kemerovo, Russia, Kemerovo Cardiology Centre, Department of Turkey, Çukurova University, Department of Anesthesiology); Deniz Karakaya, Anesthesiology); Michael Yaroustovsky, Marina Abramyan, Ekaterina Komardina Burhan Dost, Ozgur Komurcu (Samsun, Turkey, Mayıs University, Department of (Moscow, Russia, Bakulev Scientific Center for Cardiovascular Surgery, Department Anesthesiology); Özlem Korkmaz Dilmen, Eren Fatma Akcil, Özlem Korkmaz Dilmen, of Anesthesiology); Nataliya Lesteva, Medina Aybazova, Elmira Kumykova, Svetlana Yusuf Tunali (Istanbul, Turkey, Istanbul University Cerrahpasa, Cerrahpasa Faculty of Lesina, Gennady Rybakov, Alexey Shestov (St. Petersburg, Russia, Almazov National Medicine, Department of Anesthesiology and Intensive Care Medicine); Gülay Ok, Medical Research Centre, Polenov Neurosurgical Institute, Department of Eda Tok Alsina, Özge Hakli (Manisa, Turkey, Manisa Celal Bayar University, Medical Anesthesiology and Intersive care); Abdulnaser Ahmad Ahmad Barmou, Bushra Lotfi Faculty, Department of Anesthesiology and Reanimation); Cengiz Polat, Namigar Altayeb Ahmed, Aisha Mohammad Eliyas, Yousra Emadeldin (Al Khobar, Saudi Turgut (Istanbul, Turkey, Prof. Dr. Cemil Tascioglu City Hospital, Department of Arabia, Almana General Hospital Al-­Khobar, Department of Cardiology); Alexander Anesthesiology); Nurcan Kızılcık, Özge Köner (Istanbul, Turkey, Yeditepe University, Kaserer,Clara Castellucci, Julian Rössler, Samira Akbas (Zürich, Switzerland, Faculty of Medicine); Öznur Şen, Nurdan Aydin, Burcu Basaran, Emre Sertac Bingul University Hospital Zürich, Institute for Anesthesiology); Andreja Möller Petrun, Irena (Istanbul, Turkey, Haseki Sultangazi Research and Training Hospital, Department of Gregorcic, Vesna Sok (Maribor, Slovenia, University Medical Centre Maribor, Anesthesiology and Intensive Care); Yavuz Gürkan, Kamil Darcin, Semra Ugur Department of Anesthesiology and Intensive Care); Roman Čičak (Murska Sobota, (Istanbul, Turkey, University Hospital Koç, Department of Anesthesiology and Slovenia, General Hospital of Murska Sobota, Department of Anesthesiology and Reanimation); Kemal Tolga Saracoglu (Istanbul, Turkey, Health Sciences University Perioperative Medicine); Elizabeth Bárcena, Antonio Guisado, Ismail Wi (Granada, Kartal Dr. Lutfi Kirdar Training and Research Hospital, Department of Anesthesiology Spain, University Hospital Vrigen de las Nieves, Department of Anaesthesia, Critical and Intensive Care); Asli Demir, Özgök Aysegül, Eda Balci, Behic Girgin, Aygun Guler, Care and Pain Therapy); Javier Ripollés Melchor (Madrid, Spain, University Hospital Ümit Karadeniz, Nihal Özaslan, Yigit Özay Hülya, Namik Ozcan, Aysun Postaci, Infanta Leonor, Department of Anesthesiology and Intensive Care); Ángel Mehmet Sahap, Nevriye Salman (Ankara, Turkey, Ankara City Hospital, Department Becerra-­Bolaños, Sergio Cabrera-­Doreste, Ancor Domínguez-­Arbelo, María of Anesthesiology); Özlem Sağır, Bulent Atik, Murat Bicakcioglu, Hafize Fisun Demir, Candelaria Delgado-­Alonso, Virginia Muiño-­Palomar, Aurelio Rodríguez-­Pérez (Gran Ugün Fatih, Nazan Kocaoglu (Balikesir, Turkey Balikesir University, Department of Canaria, Spain, University Hospital Gran Canaria Doctor Negrín, Department of Anesthesiology and Intensive Care); Hüseyin ilksen Toprak, Duygu Demiröz Aslan, Anesthesiology and Intensive Care); Javier Mata Estévez, Maria Begona Covas Yusuf Ziya Colak (Malatya, Turkey, University Hospital Inonu, Department of Munoz, Juan Mulet Matas, Sara Perez Palao, Maria Dolores Mira Quirós, Alisia Anaesthesiology and Reanimation); Mustafa Soner Ozcan (Isparta, Turkey, Suleyman Protected by copyright. Cezara Teslev (Palma de Mallorca, Spain University Hospital Son Llàtzer, Department Demirel University School of Medicine, Department: Anesthesiology and of Anesthesiology and Pain Medicine); Mercedes Garcia Alvarez, Marga Argilaga, Reanimation); Mehmet Yilmaz (Department of Anesthesiology and Reanimation, María Campos, Albert Bainac, Astrid Batalla, Mercedes Garcia Alvarez, Marta Giné, Health Sciences University Medical School, Derince, Kocaeli, Turkey); Umran Karaca Gracia Herránz, Ignacio Hinojal (Barcelona, Spain, University of Barcelona, Hospital (Bursa, Turkey, University of Health Sciences Turkey, Yuksek Ihtisas Training and de Sant Pau, Department of Anesthesiology and Pain Medicine); Margarita Logroño Research Hospital, Department of Anesthesiology and Reanimation); Sevtap Ejea, Noelia de la Rosa Ruiz, María Gastaca Abasolo, Carla Rosario Houhton Acuna, Hekimoglu Sahin (Edirne, Turkey, Trakya University, Faculty of Medicine Department Ibai Iriarte Zaranton, Ana Mendigurenmurua, María José Munoz Sanz, Erika Olea de of Anesthesiology and Reanimation); Özlem Ersoy Karka, Gizem Demir Şenoğlu la Fuente, María Pilar Pérez Vaquero, Ana Soto Iglesias, Ana Ugarte Mieres, Alaitz (Düzce, Turkey, Düzce University, Department of Anesthesiology and Reanimation); Urtiaga Urrestizala (Vitoria-­Gasteiz, Spain, University Hospital Araba (Txagorritxu Süheyla Erkoç Karadağ, Neslihan Alkis (Ankara, Turkey, Ankara University School of Hospital Álava); Department of Anesthesiology and Intensive Care); Lourdes Ferreira, Medicine, İbni Sina Hospital); Volkan Baytaş (Ankara, Turkey, Ankara University Félix Lobato, Marta Aguado Sevilla (Logroño (La Rioja); Spain, San Pedro Hospital, School of Medicine, Cebeci Hospital); Engin Erturk, Ali Akdogan, Ahmet Besir, Engin Department of Anesthesiology); Andres Erazo, Pere Miró, Sergi Sabaté, Diana Erturk, Dilek Kutanis, Sedat Saylan, Ersagun Tugcugil (Trabzon, Turkey, Karadeniz Vernetta (Barcelona, Spain, Fundación Puigvert, Department of Anesthesiology and Technical University, Faculty of Medicine, Department of Anesthesiology and Intensive Care); Berta Castellano Paulis, Anabel Adell Perez, Marta Aseguinolaza Intensive Care); Pinar Ayvat (Izmir, Turkey, Izmir Democracy University School of Pagola, Berta Castellano Paulis, Elena del Val Peciña, Ainhoa Garmendia Odriozola, Medicine, Department of Anesthesiology and Reanimation Department); Berrin Amaia Lopetegi Aizpurua, Olatz Pavón Piquer, Pilar Plou Garcia, Paula Ortega Rezola, Günaydın, Beyza Mehri Büyükgebiz (Ankara, Turkey, Gazi University School of Antia Osorio Lopez (Donostia, Spain, University Hospital Donostia, Department of Medicine, Department of Anesthesiology); Omer Faruk Boran, Feyza Calisir, Yavuz Anesthesiology, Intensive Care and Pain Medicine); Isabel de la Calle Gil, Rosalía Orak (Kahramanmaraş, Turkey, Kahramanmaras Sutcu Imam University Faculty of Navarro Casado (Madrid, Spain, Hospital 12 de Octubre, Department of Medicine, Department of Anesthesiology and Reanimation); Bahar Kuvaki Balkan, Anesthesiology and Intensive Care); Peter Adamove, Roser Bayona Domenge, Bahar Kuvaki Balkan, Sibel Büyükcoban, Erol Gökel, Sakize Ferim Günenc, Sule Francho Miguel Blasco Blasco, Adriana Alexandra Rueda Villamizar, Maria Antonia Özbilgin (Izmir, Turkey, Dokuz Eylül Üniversitesi, Department of Anesthesiology and Perelló Llaneras (Barcelona, Spain, University Hospital Bellvitge, Department of Reanimation); Suna Göre, Selcan Akesen, Seda Cansabuncu (Bursa, Turkey, Bursa Anesthesiology); Jose Ignacio García-­Sánchez, Laura Fernandez Téllez, Sara García Uludag University, Medical Faculty, Department of Anaesthesiology and Zamorano, Natalia Gijón Herreros, Andrea Rodriguez Esteve (Madrid, Spain, Reanimation); Natalia Momot, Anna Panchenko (Zaporizhzhia, Ukraine, Zaporizhzhia University Hospital Fundacion Alcorcón, Departament of Anesthesiology and Critical State Medical University Hospital, Department of Anesthesiology and Intensive Care); Pablo Monedero Rodríguez, Isabel García Trigo, Agustín Alcaraz, Andrea Lara Care); Jean-­Francois Pittet, Kristen Rutledge (Birmingham, USA University of Jiménez, Iñigo Rubio, Nuria García, Raquel Callejas (Navarra, Spain, University Alabama, Department of Anesthesiology and Perioperative Medicine). Hospital Navarra, Departament of Anesthesiology and Critical Care); Angel Manuel Candela Toha, Eli Claros, Pilar Cobeta, Pascual Crespo,Trini Dorado, Elena Elías, Contributors RW performed the trial and designed the manuscript; KS-­G Javier Felices, Diego Gil, María Gómez, Nuria Mané, María Martín, Adolfo Martínez, performed the trial and designed the manuscript; EPIS-­AKI Investigators performed Lucía Pereira, Alberto Balvis Noemí Samaranch, Ana Serrano, Carlos Tiscar, Judith the study. LK helped design the trial and draft the manuscript; CW helped design VillaHoz (Madrid, Spain, University Hospital Ramón y Cajal, Department of the trial, performed study coordination and drafted the manuscript; MM conceived Anesthesiology and Intensive Care, Branch Cardiovascular and Thoracic the study, designed the trial and drafted the manuscript; AZ conceived the study, Anesthesia); Patricia Galán Menéndez, Elena Cardona, Anna Conesa, Veronica designed the trial and drafted the manuscript. MM and AZ shared last authorship. Estepa, Patricia Galán, Laura Llinares Espí, Yuri Loaiza Aldeán, Susana Manrique, Funding This work was supported by an unrestricted research grant from Baxter Víctor Morales Ariza, Laura Villarino Villa (Barcelona, Spain, University Hospital Vall and the German Research Foundation (KFO342/1, ZA428/18-­1, and ZA 428/21-­1 to d’Hebron, Department of Anesthesiology and Critical Care); Elfayadh Saidahmed AZ; ME5413/1-­1 to MM). Mohamed Amed Suliman, Hytham Hamid (Omdurman, Sudan, Shargh Alneel Competing interests None declared. Hospital, Military Hospital Omdurman, Department of Anesthesia); Ahmed Mohamed Ibrahim, Modather Mohamed Saeed (Al-­Qadarif, Sudan, Gadarif Teaching Hospital, Patient consent for publication Consent obtained from parent(s)/guardian(s) 8 Weiss R, et al. BMJ Open 2021;11:e055705. doi:10.1136/bmjopen-2021-055705 Open access BMJ Open: first published as 10.1136/bmjopen-2021-055705 on 30 December 2021. Downloaded from http://bmjopen.bmj.com/ on October 6, 2023 at Univesity Autonomous of Barcelona. Provenance and peer review Not commissioned; externally peer reviewed. 14 Brunelli SM, Waikar SS, Bateman BT, et al. Preoperative statin use and postoperative acute kidney injury. Am J Med Supplemental material This content has been supplied by the author(s). It has 2012;125:1195–204. not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been 15 Kim J-­Y, Joung K-­W, Kim K-­M, et al. Relationship between a peer-­reviewed. Any opinions or recommendations discussed are solely those perioperative intravenous fluid administration strategy and acute of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and kidney injury following off-­pump coronary artery bypass surgery: an responsibility arising from any reliance placed on the content. Where the content observational study. Crit Care 2015;19:350. includes any translated material, BMJ does not warrant the accuracy and reliability 16 Kim WH, Park JY, Ok S-­H, et al. Association between the neutrophil/ of the translations (including but not limited to local regulations, clinical guidelines, lymphocyte ratio and acute kidney injury after cardiovascular surgery: a retrospective observational study. Medicine terminology, drug names and drug dosages), and is not responsible for any error 2015;94:e1867. and/or omissions arising from translation and adaptation or otherwise. 17 Bernardi MH, Schmidlin D, Ristl R, et al. Serum creatinine Back-­ Open access This is an open access article distributed in accordance with the Estimation in cardiac surgery patients: misclassification of Creative Commons Attribution Non Commercial (CC BY-­NC 4.0) license, which AKI using existing formulae and a data-­driven model. CJASN permits others to distribute, remix, adapt, build upon this work non-­commercially, 2016;11:395–404. 18 Seelhammer TG, Maile MD, Heung M, et al. Kinetic estimated and license their derivative works on different terms, provided the original work is glomerular filtration rate and acute kidney injury in cardiac surgery properly cited, appropriate credit is given, any changes made indicated, and the use patients. J Crit Care 2016;31:249–54. is non-­commercial. See: http://creativecommons.org/licenses/by-nc/4.0/. 19 Kellum JA, Sileanu FE, Murugan R, et al. Classifying AKI by urine output versus serum creatinine level. JASN 2015;26:2231–8. ORCID iDs 20 Priyanka P, Zarbock A, Izawa J. The impact of acute kidney injury Melanie Meersch http://orcid.org/0000-0002-6011-8049 by serum creatinine or urine output criteria on major adverse Alexander Zarbock http://orcid.org/0000-0002-2124-1714 kidney events in cardiac surgery patients. 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