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1. Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial): study protocol for an international, prospective, randomised controlled multicentre trial

Author

Joachim Gerss, Javier Ripollés-Melchor, Emmanuel Futier, Melanie Meersch, Carola Wempe, Detlef Kindgen-Milles, Alexander Zarbock, Markus W Hollmann, Sigismond Lasocki, Thomas Rimmele, Tim Rahmel, Michael Adamzik, Hartmuth Nowak, Ingeborg Welters, Brian Johnston, Ane Abad-motos, Alfredo Abad-gurumeta, Marc Moritz Berger, Davide Ricci, Maurizio Cecconi, Gudrun Kunst, Christian Stoppe, Christian Putensen, Marlies Ostermann, Sascha Ott, Brijesh Patel, Gabriele Baldini, Antoine Lamblin, Karen Williams, Elena Mancini, Christian Arndt, Hinnerk Wulf, Marc Irqsusi, Wim Vandenberghe, John Kellum, Raphael Weiss, Jackie Donovan, Lui G Forni, Giacomo Monti, Céline Monard, Markus A Weigand, Thorsten Brenner, Ulrich Jaschinski, Carlos Lopez, Maxime Leger, Emmanuel Rineau, Philipp Simon, María Gómez-Rojo, Lars Bergmann, Alicia Waite, Savino Spadaro, Alexander Wolf, Andrew Spence, Simon Dubler, Alexander PJ Vlaar, Patrick Schober, Ben C Creagh-Brown, Nandor Marczin, Emilio Maseda, Christian Strauss, Stefano Romagnoli, Christian Nusshag, Ulrich Gobel, Ángel Candela-Toha, Jon Silversides, Nuttha Lumlertgul, Khaschayar Saadat-Gilani, Vincent Legros, Timo Brandenburger, Thomas Dimski, Laura Huthmann, Claude Pelletier, Manon Schleß, Peter Rosenberger, Helene Häberle, Jan Gerrit Haaker, Matthias Gründel, Lucia Cattin, Laura Villarino Villa, Juan Victor Lorente, Christine Martin, Jan Larmann, Wolfgang Bauer, Giovanni Borghi, Benjamin O’Brien, Thilo von Groote, Antoine Guillaume Schneider, Silvia De Rosa, Diego Parise, Alice Bernard, Paula Fernández-Valdes-Bango, Irene Romero Bhathal, A Suarez-de-la-Rica, Gianluca Villa, Raquel García-Álvarez, Antonio Siniscalchi, Richard Ellerkmann, Florian Espeter, Christian Porschen, Mahan Sadjadi, Michael Storck, Tobias Brix, Dana Meschede, Wida Amini, Carina Stenger, Julius Freytag, Jens Brands, Matthias Unterberg, Britta Marko, Fabian Dusse, Wolfgang A Wetsch, Sandra E Stoll, Hendrik Drinhaus, Bernd W Böttiger, Onnen Mörer, Lars-Olav Harnisch, Roswitha Lubjuhn, Daniel Heise, Christian Bode, Andrea Sauer, Konrad Peukert, Lennart Wild, Philippe Kruse, Jan Menzenbach, Valbona Mirakaj, Sabine Hermann, Stefanie Decker, Mona Jung-König, Tobias Hölle, Sarah Dehne, Jörg Reutershan, Thomas Prüfer, Stefan Pielmeier, Indra Wimmelmeier, Michaela Scholz, Andrea Paris, Isabel Christina Gallego Zapata, Holger Pohl, Nirmeen Fayed, Kai Dielmann, Evelyn Martin, Tilo Koch, Alexander Mück, Philipp Deetjen, Ngoc Bich Mehlmann, Peter M Spieth, Andreas Güldner, Axel Rand, Maximillian Ragaller, Martin Mirus, Rebecca Bockholt, Marc Herzog, Maren Kleine-Brüggeney, Ant Isabelle Cristiani, Marion Ohl, Monica Vieira Da Silva, Gilda Filipe de Castro Reblo, Matthias Hilty, Katharina Spanaus, Benedetta Mura, Eleonora Terreni, Francesco Magiotti, Lorenzo Turi, Cristiana Laici, Chiara Capozzi, Andrea Castelli, Massimiliano Greco, Antonio Messina, Gianluca Castellani, Romina Aceto, Vinicio Danzi, Alessandro Rigobello, Massimo De Cal, Monica Zanella, Gaetano Scaramuzzo, Riccardo La Rosa, Paolo Priani, Alberto Volta Carlo, Stefano Turi, Martina Baiardo Redaelli, Marilena Marmiere, Kittisak Weerapolchai, Shelley Lorah, Fabiola D’Amato, Aneta Bociek, Rosario Lim, Benjie Cendreda, Reynaldo Dela Cuesta, Eirini Kosifidou, Zoka Milan, Juliana Fernanda, Emma Clarey, Daveena Meeks, Nicholas J Lees, Marco Scaramuzzi, Orinta Kviatkovske, Adam Glass, Christine Turley, Charlotte Quinn, Syeda Haider, Adam Rossiter, Syed Nasser, Ned Gilbert-Kawai, Tatjana Besse-Hammer, Eric Hoste, Hannah Schaubroeck, Jan De Waele, Jenni Breel, Eline de Klerk, Harm-Jan de Grooth, Lothar Schwarte, Alexander Loer, Alicia Ruiz-Escobar, Diana Fernández-García, Nerea Gómez-Pérez, Pascual Crespo-Aliseda, Cristina Cerro-Zaballos, Cristina Fernández-Martín, Eduardo Martín-Montero, Alejandro Suarez de la Rica, Héctor Berges Gutiérrez, Maria del Pino Heredia Pérez, Maria de los Reyes Bellido Fernández, Liena Izquierdo López, Javier Valiente Lourtau, Ma Angeles Ferre Colomer, Ma Azucena Pajares Moncho, Maria Jesús Montero Hernández, Esther Pérez Sancho, Silvia Polo Matínez, Pedro Rivera Soria, Maider Puyada Jáuregui, Hugo Rivera Ramos, Marta Antelo Adrán, Ramón Adalia Bartolomé, Patricia Galán Menéndez, Laura Llinares Espin, Yuri Santiago Loaiza Aldean, Víctor MoralesAriza, Rosalía Navarro-Perez, Luis Santé-Serna, Pedro de la Calle-Elguezabal, Rubén Sánchez-Martín, Inés De Soto, Pau Vallhonrat Alcántara, Laura Perelló Cerdà, Gal·la Rouras Hurtado, Paula Rodriguez Nieto, John Narros Sicluna, Angel Molero Molinero, Juan Pablo Nocete, Elena Murcia Sánchez, Stanislas Abrard, Marie-Luce Parrouffe, Frank Bidar, Lucie Aupetitgendre, Ugo Schiff, Bertille Paquette, Gaëlle Sellier, Nathalie Borgnetta, Benjamin Brochet, Thierry Floch, Julien Coffinet, and Marion Leclercq-Rouget

Subjects
Medicine
Abstract

Introduction Previous studies demonstrated that the implementation of the Kidney Disease Improving Global Outcomes (KDIGO) guideline-based bundle, consisting of different supportive measures in patients at high risk for acute kidney injury (AKI), might reduce rate and severity of AKI after surgery. However, the effects of the care bundle in broader population of patients undergoing surgery require confirmation.Methods and analysis The BigpAK-2 trial is an international, randomised, controlled, multicentre trial. The trial aims to enrol 1302 patients undergoing major surgery who are subsequently admitted to the intensive care or high dependency unit and are at high-risk for postoperative AKI as identified by urinary biomarkers (tissue inhibitor of metalloproteinases 2*insulin like growth factor binding protein 7 (TIMP-2)*IGFBP7)). Eligible patients will be randomised to receive either standard of care (control) or a KDIGO-based AKI care bundle (intervention). The primary endpoint is the incidence of moderate or severe AKI (stage 2 or 3) within 72 hours after surgery, according to the KDIGO 2012 criteria. Secondary endpoints include adherence to the KDIGO care bundle, occurrence and severity of any stage of AKI, change in biomarker values during 12 hours after initial measurement of (TIMP-2)*(IGFBP7), number of free days of mechanical ventilation and vasopressors, need for renal replacement therapy (RRT), duration of RRT, renal recovery, 30-day and 60-day mortality, intensive care unit length-of-stay and hospital length-of-stay and major adverse kidney events. An add-on study will investigate blood and urine samples from recruited patients for immunological functions and kidney damage.Ethics and dissemination The BigpAK-2 trial was approved by the Ethics Committee of the Medical Faculty of the University of Münster and subsequently by the corresponding Ethics Committee of the participating sites. A study amendment was approved subsequently. In the UK, the trial was adopted as an NIHR portfolio study. Results will be disseminated widely and published in peer-reviewed journals, presented at conferences and will guide patient care and further research.Trial registration number NCT04647396.

Published
2023
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2. EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI): study protocol for a multicentre, observational trial

Author

Melanie Meersch, Mira Küllmar, Carola Wempe, Alexander Zarbock, Ke Peng, Sigismond Lasocki, Thomas Rimmele, Maria Martin, Olivier Desebbe, Michele Rossi, Matthias Heringlake, Christina Massoth, Raphael Weiss, Andreas Höhn, Gael Pradel, Ana Kowark, Ahmed mohamed Ibrahim, Orestis Ioannidis, Andrea Cortegiani, Maxime Leger, Emmanuel Rineau, Pierre-Yves Egreteau, Andrea Russo, Laura Kerschke, Savino Spadaro, Carole Ichai, Vincent Cottenceau, Sebastian Ziemann, Maria Gomez, Julien Nadaud, Olivier Pérus, Philippe Magazzeni, Philippe Montravers, Deniz Karakaya, Christophe Aveline, Alexander Bentley, Tulay Ozkan Seyhan, Jean-François Pittet, Sébastien Ponsonnard, Pierre Garcon, Ana Serrano, Gulay Ok, Pierre Vautier, Jean François Gautier, Sergi Sabaté, Yusuf Tunali, Valérie Cerro, Stephanie Suria, Khaschayar Saadat-Gilani, Hichem Makhloufi, Anis Cherak, Lamine Lakhel Ghanem, Zohier Gouaglia, Dina Nasrine Guadouri, Fayrouz Naouel Hama, Mustafa Kara, Omayma Saadi, Rachida Sakhraoui, Fadila Bourou, Abdelhadi Cherifi, Rahmoune Ghania Sadaoui, Amel Ouyahia, Ilhem Ouahab, Souad Bouaoud, Meriem Abdoun, Anisse Tidjane, Benali Tabeti, Nabil Boudjenan-Serradj, Carlos Jose Pérez Rivera, Paulo Cabrer, Julián Corso, Juan Pablo García, Sharon Idarraga, Christopher Montoya, Rafael Figueroa, Eduar Aldana, María Alejandra Torrado, Zheng-min Ma, Yu-fan Yang, Ya-juan Zhu, Peter Sklienka, Michal Frelich, Vojtech Jarkulis, Pavel Sevcik, Vojtech Vodicka, Mohamed Gamal Elbahnasawy, Shady Elsalhawy, Sara Motawea, Zeinab Othman, Mohamed Sahma, Ahmed Mahmoud Nafea, Nermin Ahmed, Doaa Ali Attia, Moataz Maher Emara, Mohamed Mamdouh Bonna, Mohamed Ahmed Gabr, Amany Ismail Tarbay, Ibrahim Abdelmonaem Abdehaleem, Esraa Elsayed Mohamed, Amr Mahmoud Eldeeb, Ahmed Mohamed Abbas, John Ashraf Magdy, Zyad Hassan Hamed, Hany Mostafa Esmaeil Osman, Mostafa Samy Abbas, Oliver Joannes-Boyau, Nicolas Barraud, Corentin Berthelot, Thibault Camus, Anissa Dahmi, Mylène Defaye, Sébastien Derville, Younes El-Boustani, Elsa Deloge, Hélène Jacob, Simon Monziols, Fred Priem, Jean-Jacques Robin, Vincent Legros, Therry Floch, Salvatore Muccio, Claire Geneve, Marie Lim Legouge, Stéphanie Tao Mauny, Willy Mfam, Léa Pascot, Mireille Chartier, Benjamin Duteurtre, Aidren Le Cousin, Nathalie Begel, Claire-Annissa Chekirine, Vincent Derlon, Elodie Grein, Marie-Annick Lehair, Laurent Magazzeni, Carsten Potter, Catherine Roth, Florence Voivret, Jamil Elmawieh, Annabelle Stoclin, Cédric Cirenei, Gregoire Andrieu, Sven Couloumy, Jeremy Falcone, Marion Fajardy, Arsène Gagneuil, Emeline Girardet, Agnès Mazereeuw, Mélanie Bertel, Simon Bocher, Vanessa Carn, Lenaïg Le Guen, Guillaume Le Loup, Montaine Lefevre, Amanita Diop, Vanessa Jean-Michel, Sylvie Devlieger, Juliette Duthoit, Mohamed El Kadiri, Viviane Cassisa, Charline Masson, Pierre Verrier, Axel Coquerel, Enora Atchade, Charles-Edouard Rochon, Céline Delerue, Vidal Quentin, Vanessa Latry, Nina Queixalos, Thierry Braun, Saad Bouzoubaa, Basile Christ, Audrey Geiger, Joachim Gomille, Vianney Kieffer, Simone Mangeant, Christelle Prochilo, Christian Schmitt, Stefan Skwirba, Hubert Grand, Frédérique Boury, Nicolas Mayeur, Marie Pasquie, Vincent Bruckert, Vincent Arnould, Mona Bonciu, Thibault Chapelle, Luc Facchino, Florence Fagot-Gandet, Andrea Iachim, Elena Mannu, Rémi Plattier, Romain Rozier, Michel Boudinaud, Marie-Hélène Hausermann, My Hue Nguyen, Andersen Ramorasata, Amélie Barreau, Anne-Hélène Boivin, Céline Ravry, Nicolas Mottard, Johanne Beuvelot, Florence Prunier Bossion, Christian Dörr, Thilo Caspar von Groote, Linda Grüßer, Pia Wittig, Timo Brandenburger, Thomas Dimski, Niklas Döhmen, Laura Huthmann, Daniela Kaierle, Claude Pelletier, Manon Schleß, Sebastian Cleophas, Stephanie Haunhorst, Marina Jansen, Alexandra Schmitt, Julia Soisch, Kilian Sturm, Peter Rosenberger, Alexander Bendig, Lena Flohr, Helene Häberle, Pascal Hofmann, Jonathan Kuhle, Nora Michaela Leser, Kathrin Pfister, Stefanie Prohaska, Franziska Sennholz, Lena Stetz, Kathrin Weber, Sebastian Stehr, Stephan Klaus, Marco Sadlo, Matthias Boschin, Christian Sengelhoff, Ulrich Michael Göbel, Jan Gerrit Haaker, Carina-Kristin Göttker, Matthias Gründel, Romina Baumgärtel, Astrid Berggren, Madeleine Gülzow, Lennart Muras, Hauke Paarmann, Serge Thal, Dschamil El-Masri, Eleni Arnaoutoglou, Maria Ntalouka, Paula Stratigopoulou, Anastasia Analytis, Efthymios Mavrommatis, Petros Tzimas, Agathi Karakosta, Danai Pantazi, Antonia Dimakopoulou, Katerina Dimitropoulou, Humam Jalaawiy, Aeshah Anwar, Hashim Talib Hashim, Hogir Imad Rasheed Aldawoody, Giulia Catalisano, Gilia Ingoglia, Mariachiara Ippolito, Silvia De Rosa, Lucia Cattin, Andrea Bianchin, Marisa Barone, Gianluca Paternoster, Salvatore Lucio Cutuli, Liliana Sollazzi, Laura Cascarano, Massimo Antonelli, Paola Aceto, Bruno Romanò, Vincenzo Francesco Tripodi, Rosamaria Scappatura, Maria Cristina Vadalà, Diego Fiume, Maria Teresa Strano, Giulia Oddo, Clemente Santorsola, Bilal Abu Hussain, Adnan Raed Alnaser, Anas Hassouneh Ghassan, Khaled Hasanein, Mohammed Theab, Seokyung Shin, Seungho Jung, Kyuho Lee, Sung Mee Jung, Jongyoon Baek, Muhammed K. Elhadi, Issa Abuzeid, Mohammed Albaraesi, Sarah Aldressi, Wegdan Khalel, Eman Abdulwahed, Akram Abdulhamid Ashur Abujrad, Amer Almaghrabi, Muhand Mohammed Alteleeb, Entisar Ahmed Ali Alshareea, Marwa Isa Biala, Abdulqudus Deeknah, Dooua Ali Gheddim, Reem Ghmagh, Nawras Salih Ali AbuIkhrays, Marwa Sinan, Enas Soula, Sumayyah Ghayth Bahroun, Khawla Derwish, Aya Munir Mohamed, Eman Sayed Younes, Rayet Al Islam Benjouira, Mohamed Aliwa, Najwa Abdullah Altashani, Mohammed Omar Alteb, Ahmed Msherghi, Fatima Alagelli, Sufyan Albarouni, Ahmed Albishti, Sarah Aljamal, Mohamed Alsori, Taha Ekhuja, Suha Elzwai, Mohammed Ghula, Tahani Mustafa, Ahmed Tuwaib, Haifa Zriba, Hamza Mahmoud Agilla, Toky Andriamahefa Rafanomezantsoa, Anne Marie Camilleri Podesta, Denise Mifsud Bonnici, Tiziana Pirotta, Gilberto Adrián Gasca López, Maja Mojsova Mijovska, Tatjana Davitkovska, Aleksandra Gavrilovska, Sanja Lukikj, Marija Vesova, Dina Zafirova, Sarah Amro, Baraa N. F. Hajjaj, Muawia Alkhazendar, Yousuf Barakat, Sewar Abdulaziz Elejla, Ahmed Elhissi, Ahmed Khader, Ali Salem, Rita de Freitas Regufe, André Filipe de Oliveira Eloy, Lisbete Marisa Neto Cordeiro Perdigão, Evgeny Grigoriev, Artem Ivkin, Roman Kornelyuk, Michael Yaroustovsky, Marina Abramyan, Ekaterina Komardina, Nataliya Lesteva, Medina Aybazova, Elmira Kumykova, Svetlana Lesina, Gennady Rybakov, Alexey Shestov, Abdulnaser Ahmad Ahmad Barmou, Bushra Lotfi Altayeb Ahmed, Aisha Mohammad Eliyas, Yousra Emadeldin, Alexander Kaserer, Clara Castellucci, Julian Rössler, Samira Akbas, Andreja Möller Petrun, Irena Gregorcic, Vesna Sok, Roman Čičak, Elizabeth Bárcena, Antonio Guisado, Ismail Wi, Javier Ripollés Melchor, Ángel Becerra-Bolaños, Sergio Cabrera-Doreste, Ancor Domínguez-Arbelo, María Candelaria Delgado-Alonso, Virginia Muiño-Palomar, Aurelio Rodríguez-Pérez, Javier Mata Estévez, Maria Begona Covas Munoz, Juan Mulet Matas, Sara Perez Palao, Maria Dolores Mira Quirós, Alisia Cezara Teslev, Mercedes Garcia Alvarez, Marga Argilaga, María Campos, Albert Bainac, Astrid Batalla, Marta Giné, Gracia Herránz, Ignacio Hinojal, Margarita Logroño Ejea, Noelia de la Rosa Ruiz, María Gastaca Abasolo, Carla Rosario Houhton Acuna, Ibai Iriarte Zaranton, Ana Mendigurenmurua, María José Munoz Sanz, Erika Olea de la Fuente, María Pilar Pérez Vaquero, Ana Soto Iglesias, Ana Ugarte Mieres, Alaitz Urtiaga Urrestizala, Lourdes Ferreira, Félix Lobato, Marta Aguado Sevilla, Andres Erazo, Pere Miró, Diana Vernetta, Berta Castellano Paulis, Anabel Adell Perez, Marta Aseguinolaza Pagola, Elena delVal Peciña, Ainhoa Garmendia Odriozola, Amaia Lopetegi Aizpurua, Olatz Pavón Piquer, Pilar Plou Garcia, Paula Ortega Rezola, Antia Osorio Lopez, Isabel de la Calle Gil, Rosalía Navarro Casado, Peter Adamove, Roser Bayona Domenge, Francho Miguel Blasco Blasco, Adriana Alexandra Rueda Villamizar, Maria Antonia Perelló Llaneras, Jose Ignacio García-Sánchez, Laura Fernandez Téllez, Sara García Zamorano, Natalia Gijón Herreros, Andrea Rodriguez Esteve, Pablo Monedero Rodríguez, Isabel García Trigo, Agustín Alcaraz, Andrea Lara Jiménez, Iñigo Rubio, Nuria García, Raquel Callejas, Angel Manuel Candela Toha, Eli Claros, Pilar Cobeta, Pascual Crespo, Trini Dorado, Elena Elías, Javier Felices, Diego Gil, Nuria Mané, Adolfo Martínez, Lucía Pereira, Alberto Balvis Noemí Samaranch, Carlos Tiscar, Judith VillaHoz, Patricia Galán Menéndez, Elena Cardona, Anna Conesa, Veronica Estepa, Laura Llinares Espí, Yuri Loaiza Aldeán, Susana Manrique, Víctor Morales Ariza, Laura Villarino Villa, Elfayadh Saidahmed Mohamed Amed Suliman, Hytham Hamid, Modather Mohamed Saeed, Orhan Sungur Mukadder, Demet Altun, Nur Canbolat, Müşerref Beril Dinçer, Serap Aktaş Yıldırım, Müzeyyen İyigün, Davut Yapıcı, Levent Özdemir, Aslinur Sagun, Neval Boztug, Yesim Cetintas, Bora Dinc, Emel Gündüz, Hakkı Ünlügenç, Demet Lafli Tunay, Ozgur Komurcu, Özlem Korkmaz Dilmen, Eren Fatma Akcil, Eda Tok Alsina, Özge Hakli, Cengiz Polat, Namigar Turgut, Nurcan Kızılcık, Özge Köner, Öznur Şen, Nurdan Aydin, Burcu Basaran, Emre Sertac Bingul, Kamil Darcin, Semra Ugur, Kemal Tolga Saracoglu, Asli Demir, Özgök Aysegül, Eda Balci, Behic Girgin, Aygun Guler, Ümit Karadeniz, Nihal Özaslan, Yigit Özay Hülya, Namik Ozcan, Aysun Postaci, Mehmet Sahap, Nevriye Salman, Özlem Sağır, Bulent Atik, Murat Bicakcioglu, Hafize Fisun Demir, Ugün Fatih, Nazan Kocaoglu, Hüseyin ilksen Toprak, Duygu Demiröz Aslan, Yusuf Ziya Colak, Mustafa Soner Ozcan, Mehmet Yilmaz, Umran Karaca, Sevtap Hekimoglu Sahin, Özlem Ersoy Karka, Gizem Demir Şenoğlu, Süheyla Erkoç Karadağ, Neslihan Alkis, Volkan Baytaş, Engin Erturk, Ali Akdogan, Ahmet Besir, Dilek Kutanis, Sedat Saylan, Ersagun Tugcugil, Pinar Ayvat, Berrin Günaydın, Beyza Mehri Büyükgebiz, Omer Faruk Boran, Feyza Calisir, Yavuz Orak, Bahar Kuvaki Balkan, Sibel Büyükcoban, Erol Gökel, Sakize Ferim Günenc, Sule Özbilgin, Suna Göre, Selcan Akesen, Seda Cansabuncu, Natalia Momot, Anna Panchenko, and Kristen Rutledge

Subjects
Medicine
Abstract

Introduction More 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 analysis EPIS-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 dissemination EPIS-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 number NCT04165369.

Published
2021
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3. Secreted Cytokines within the Urine of AKI Patients Modulate TP53 and SIRT1 Levels in a Human Podocyte Cell Model

Author

Lars Erichsen, Chantelle Thimm, Wasco Wruck, Daniela Kaierle, Manon Schless, Laura Huthmann, Thomas Dimski, Detlef Kindgen-Milles, Timo Brandenburger, and James Adjaye

Subjects
Inorganic Chemistry, Organic Chemistry, acute kidney injury, cytokines, TP53, SIRT1, General Medicine, Physical and Theoretical Chemistry, Molecular Biology, Spectroscopy, Catalysis, Computer Science Applications
Abstract

Acute kidney injury (AKI) is a major kidney disease with a poor clinical outcome. It is a common complication, with an incidence of 10–15% of patients admitted to hospital. This rate even increases for patients who are admitted to the intensive care unit, with an incidence of >50%. AKI is characterized by a rapid increase in serum creatinine, decrease in urine output, or both. The associated symptoms include feeling sick or being sick, diarrhoea, dehydration, decreased urine output (although occasionally the urine output remains normal), fluid retention causing swelling in the legs or ankles, shortness of breath, fatigue and nausea. However, sometimes acute kidney injury causes no signs or symptoms and is detected by lab tests. Therefore, the identification of cytokines for the early detection and diagnosis of AKI is highly desirable, as their application might enable the prevention of the progression from AKI to chronic kidney disease (CKD). In this study, we analysed the secretome of the urine of an AKI patient cohort by employing a kidney-biomarker cytokine assay. Based on these results, we suggest ADIPOQ, EGF and SERPIN3A as potential cytokines that might be able to detect AKI as early as 24 h post-surgery. For the later stages, as common cytokines for the detection of AKI in both male and female patients, we suggest VEGF, SERPIN3A, TNFSF12, ANPEP, CXCL1, REN, CLU and PLAU. These cytokines in combination might present a robust strategy for identifying the development of AKI as early as 24 h or 72 h post-surgery. Furthermore, we evaluated the effect of patient and healthy urine on human podocyte cells. We conclude that cytokines abundant in the urine of AKI patients trigger processes that are needed to repair the damaged nephron and activate TP53 and SIRT1 to maintain the balance between proliferation, angiogenesis, and cell cycle arrest.

Published
2023
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4. Cytokines in the Urine of AKI patients regulate TP53 and SIRT1 and can be used as biomarkers for the early detection of AKI

Author

Lars Erichsen, Chantelle Thimm, Wasco Wruck, Daniela Kaierle, Manon Schless, Laura Huthmann, Thomas Dimski, Detlef Kindgen-Milles, Timo Brandenburger, and James Adjaye

Abstract

Acute kidney injury (AKI) is a major kidney disease with a poor clinical outcome. It is a common complication with an incidence of 10-15% of patients admitted to hospital. This rate even increases for patients who are admitted to the intensive care unit with an incidence of >50%. AKI is characterized by a rapid increase in serum creatinine, decrease in urine output, or both. Associated Symptoms include feeling sick or being sick, diarrhoea, dehydration, decreased urine output-although occasionally urine output remains normal, fluid retention-causing swelling in the legs or ankles, shortness of breath, fatigue and nausea. However, sometimes acute kidney injury causes no signs or symptoms and is detected by lab tests. Therefore, an urgent demand for non-invasive biomarkers for early detection of AKI are highly desirable. This might enable the prevention of the progression from AKI to CKD.In this study, we analysed the secretome of urine of an AKI patient cohort employing a kidney-biomarker cytokine assay. Based on these results we suggest, ADIPOQ, EGF and SERPIN3A as potential biomarkers, which might be able to detect AKI as soon as 24 h post-surgery. For the later stages, common biomarkers for the detection of AKI in both male and female patients we suggest, VEGF, SERPIN3A, TNFSF12, ANPEP, CXCL1, REN, CLU and PLAU. These markers in combination might present a robust strategy to identify the development of AKI as early as 24h or 72h post-surgery. Furthermore, we evaluated the effect of patient and healthy urine on human podocyte cells. We conclude that cytokines in the urine of AKI patients trigger processes which are needed to repair the damaged nephron and activate TP53 and SIRT1 to maintain the balance between proliferation, angiogenesis, and cell cycle arrest. In conclusion, the Renin-Angiotensin pathway seems to have major implications.

Published
2023
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5. EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI): study protocol for a multicentre, observational trial

Author

Weiss, Raphael, Saadat-Gilani, Khaschayar, Kerschke, Laura, Wempe, Carola, Meersch, Melanie, Zarbock, Alexander Hichem Makhloufi, Anis, Cherak, Lamine Lakhel Ghanem, Zohier, Gouaglia, Dina Nasrine Guadouri, Fayrouz Naouel Hama, Mustafa, Kara, Omayma, Saadi, Rachida, Sakhraoui, Fadila, Bourou, Abdelhadi, Cherifi, Rahmoune Ghania Sadaoui, Amel, Ouyahia, Ilhem, Ouahab, Souad, Bouaoud, Meriem, Abdoun, Anisse, Tidjane, Benali, Tabeti, Nabil, Boudjenan-Serradj, Carlos Jose Pérez Rivera, Paulo, Cabrer, Julián, Corso, Juan Pablo García, Sharon, Idarraga, Christopher, Montoya, Rafael, Figueroa, Eduar, Aldana, María Alejandra Torrado, Peng, Ke, Zheng-Min, Ma, Yu-Fan, Yang, Ya-Juan, Zhu, Peter, Sklienka, Michal, Frelich, Vojtech, Jarkulis, Pavel, Sevcik, Vojtech, Vodicka, Mohamed Gamal Elbahnasawy, Shady, Elsalhawy, Sara, Motawea, Zeinab, Othman, Mohamed, Sahma, Ahmed Mahmoud Nafea, Nermin, Ahmed, Doaa Ali Attia, Moataz Maher Emara, Mohamed Mamdouh Bonna, Mohamed Ahmed Gabr, Amany Ismail Tarbay, Ibrahim Abdelmonaem Abdehaleem, Esraa Elsayed Mohamed, Amr Mahmoud Eldeeb, Ahmed Mohamed Abbas, John Ashraf Magdy, Zyad Hassan Hamed, Hany Mostafa Esmaeil Osman, Mostafa Samy Abbas, Oliver, Joannes-Boyau, Nicolas, Barraud, Corentin, Berthelot, Thibault, Camus, Anissa, Dahmi, Mylène, Defaye, Sébastien, Derville, Younes, El-Boustani, Elsa, Deloge, Hélène, Jacob, Simon, Monziols, Fred, Priem, Jean-Jacques, Robin, Vincent, Legros, Therry, Floch, Salvatore, Muccio, Claire, Geneve, Marie Lim Legouge, Stéphanie Tao Mauny, Willy, Mfam, Léa, Pascot, Christophe, Aveline, Mireille, Chartier, Benjamin, Duteurtre, Jean Francois Gautier, Aidren Le Cousin, Pierre, Vautier, Julien, Nadaud, Nathalie, Begel, Claire-Annissa, Chekirine, Vincent, Derlon, Elodie, Grein, Marie-Annick, Lehair, Laurent, Magazzeni, Philippe, Magazzeni, Carsten, Potter, Catherine, Roth, Florence, Voivret, Thomas, Rimmelé, Valérie, Cerro, Stéphanie, Suria, Jamil, Elmawieh, Annabelle, Stoclin, Cédric, Cirenei, Gregoire, Andrieu, Sven, Couloumy, Jeremy, Falcone, Marion, Fajardy, Arsène, Gagneuil, Emeline, Girardet, Agnès, Mazereeuw, Sébastien, Ponsonnard, Pierre-Yves, Egreteau, Mélanie, Bertel, Simon, Bocher, Vanessa, Carn, Lenaïg Le Guen, Guillaume Le Loup, Montaine, Lefevre, Carole, Ichai, Amanita, Diop, Vanessa, Jean-Michel, Sylvie, Devlieger, Juliette, Duthoit, Mohamed El Kadiri, Maxime, Léger, Viviane, Cassisa, Sigismond, Lasocki, Charline, Masson, Emmanuel, Rineau, Pierre, Verrier, Axel, Coquerel, Philippe, Montravers, Enora, Atchade, Charles-Edouard, Rochon, Céline, Delerue, Vidal, Quentin, Vanessa, Latry, Nina, Queixalos, Vincent, Cottenceau, Thierry, Braun, Saad, Bouzoubaa, Basile, Christ, Audrey, Geiger, Joachim, Gomille, Vianney, Kieffer, Simone, Mangeant, Christelle, Prochilo, Christian, Schmitt, Stefan, Skwirba, Hubert, Grand, Frédérique, Boury, Nicolas, Mayeur, Marie, Pasquie, Pierre, Garçon, Vincent, Bruckert, Vincent, Arnould, Mona, Bonciu, Thibault, Chapelle, Luc, Facchino, Florence, Fagot-Gandet, Andrea, Iachim, Elena, Mannu, Olivier, Perus, Rémi, Plattier, Romain, Rozier, Gaël, Pradel, Michel, Boudinaud, Marie-Hélène, Hausermann, My Hue Nguyen, Andersen, Ramorasata, Amélie, Barreau, Anne-Hélène, Boivin, Céline, Ravry, Nicolas, Mottard, Johanne, Beuvelot, Florence Prunier Bossion, Olivier, Desebbe, Alexander, Zarbock, Christian, Dörr, Thilo Caspar von Groote, Mira, Küllmar, Christina, Massoth, Melanie, Meersch, Khaschayar, Saadat-Gilani, Raphael, Weiss, Carola, Wempe, Sebastian, Ziemann, Linda, Grüßer, Ana, Kowark, Pia, Wittig, Timo, Brandenburger, Thomas, Dimski, Niklas, Döhmen, Laura, Huthmann, Daniela, Kaierle, Claude, Pelletier, Manon, Schleß, Andreas, Hohn, Sebastian, Cleophas, Stephanie, Haunhorst, Marina, Jansen, Alexandra, Schmitt, Julia, Soisch, Kilian, Sturm, Peter, Rosenberger, Alexander, Bendig, Lena, Flohr, Helene, Häberle, Pascal, Hofmann, Jonathan, Kuhle, Nora Michaela Leser, Kathrin, Pfister, Stefanie, Prohaska, Franziska, Sennholz, Lena, Stetz, Kathrin, Weber, Sebastian, Stehr, Stephan, Klaus, Marco, Sadlo, Matthias, Boschin, Christian, Sengelhoff, Ulrich Michael Göbel, Jan Gerrit Haaker, Carina-Kristin, Göttker, Matthias, Gründel, Matthias, Heringlake, Romina, Baumgärtel, Astrid, Berggren, Madeleine, Gülzow, Lennart, Muras, Hauke, Paarmann, Serge, Thal, Alexander, Bentley, Dschamil, El-Masri, Anne, Sebastiani, Eleni, Arnaoutoglou, Maria, Ntalouka, Paula, Stratigopoulou, Anastasia, Analytis, Efthymios, Mavrommatis, Petros, Tzimas, Agathi, Karakosta, Danai, Pantazi, Antonia, Dimakopoulou, Katerina, Dimitropoulou, Orestis, Ioannidis, Humam, Jalaawiy, Aeshah, Anwar, Hashim Talib Hashim, Hogir Imad Rasheed Aldawoody, Andrea, Cortegiani, Giulia, Catalisano, Gilia, Ingoglia, Mariachiara, Ippolito, De Rosa, Silvia, Lucia, Cattin, Andrea, Bianchin, Marisa, Barone, Gianluca, Paternoster, Salvatore Lucio Cutuli, Andrea, Russo, Liliana, Sollazzi, Laura, Cascarano, Massimo, Antonelli, Paola, Aceto, Bruno, Romanò, Savino, Spadaro, Vincenzo Francesco Tripodi, Michele, Rossi, Rosamaria, Scappatura, Maria Cristina Vadalà, Diego, Fiume, Maria Teresa Strano, Giulia, Oddo, Clemente, Santorsola, Bilal Abu Hussain, Adnan Raed Alnaser, Anas Hassouneh Ghassan, Khaled, Hasanein, Mohammed, Theab, Seokyung, Shin, Seungho, Jung, Kyuho, Lee, Sung Mee Jung, Jongyoon, Baek, Muhammed, K Elhadi, Issa, Abuzeid, Mohammed, Albaraesi, Sarah, Aldressi, Wegdan, Khalel, Eman, Abdulwahed, Akram Abdulhamid Ashur Abujrad, Amer, Almaghrabi, Muhand Mohammed Alteleeb, Entisar Ahmed Ali Alshareea, Marwa Isa Biala, Abdulqudus, Deeknah, Dooua Ali Gheddim, Reem, Ghmagh, Nawras Salih Ali AbuIkhrays, Marwa, Sinan, Enas, Soula, Sumayyah Ghayth Bahroun, Khawla, Derwish, Aya Munir Mohamed, Eman Sayed Younes, Rayet Al Islam Benjouira, Mohamed, Aliwa, Najwa Abdullah Altashani, Mohammed Omar Alteb, Ahmed, Msherghi, Fatima, Alagelli, Sufyan, Albarouni, Ahmed, Albishti, Sarah, Aljamal, Mohamed, Alsori, Taha, Ekhuja, Suha, Elzwai, Mohammed, Ghula, Tahani, Mustafa, Ahmed, Tuwaib, Haifa, Zriba, Hamza Mahmoud Agilla, Toky Andriamahefa Rafanomezantsoa, Anne Marie Camilleri Podesta, Denise Mifsud Bonnici, Tiziana, Pirotta, Gilberto Adrián Gasca López, Maja Mojsova Mijovska, Tatjana, Davitkovska, Aleksandra, Gavrilovska, Sanja, Lukikj, Marija, Vesova, Dina, Zafirova, Sarah, Amro, Baraa N, F Hajjaj, Muawia, Alkhazendar, Yousuf, Barakat, Sewar Abdulaziz Elejla, Ahmed, Elhissi, Ahmed, Khader, Ali, Salem, Rita de Freitas Regufe, André Filipe de Oliveira Eloy, Lisbete Marisa Neto Cordeiro Perdigão, Evgeny, Grigoriev, Artem, Ivkin, Roman, Kornelyuk, Michael, Yaroustovsky, Marina, Abramyan, Ekaterina, Komardina, Nataliya, Lesteva, Medina, Aybazova, Elmira, Kumykova, Svetlana, Lesina, Gennady, Rybakov, Alexey, Shestov, Abdulnaser Ahmad Ahmad Barmou, Bushra Lotfi Altayeb Ahmed, Aisha Mohammad Eliyas, Yousra, Emadeldin, Alexander, Kaserer, Clara, Castellucci, Julian, Rössler, Samira, Akbas, Andreja Möller Petrun, Irena, Gregorcic, Vesna, Sok, Roman, Čičak, Elizabeth, Bárcena, Antonio, Guisado, Ismail, Wi, Javier Ripollés Melchor, Ángel, Becerra-Bolaños, Sergio, Cabrera-Doreste, Ancor, Domínguez-Arbelo, María Candelaria Delgado-Alonso, Virginia, Muiño-Palomar, Aurelio, Rodríguez-Pérez, Javier Mata Estévez, Maria Begona Covas Munoz, Juan Mulet Matas, Sara Perez Palao, Maria Dolores Mira Quirós, Alisia Cezara Teslev, Mercedes Garcia Alvarez, Marga, Argilaga, María, Campos, Albert, Bainac, Astrid, Batalla, Marta, Giné, Gracia, Herránz, Ignacio, Hinojal, Margarita Logroño Ejea, Noelia de la Rosa Ruiz, María Gastaca Abasolo, Carla Rosario Houhton Acuna, Ibai Iriarte Zaranton, Ana, Mendigurenmurua, María José Munoz Sanz, Erika Olea de la Fuente, María Pilar Pérez Vaquero, Ana Soto Iglesias, Ana Ugarte Mieres, Alaitz Urtiaga Urrestizala, Lourdes, Ferreira, Félix, Lobato, Marta Aguado Sevilla, Andres, Erazo, Pere, Miró, Sergi, Sabaté, Diana, Vernetta, Berta Castellano Paulis, Anabel Adell Perez, Marta Aseguinolaza Pagola, Elena delVal Peciña, Ainhoa Garmendia Odriozola, Amaia Lopetegi Aizpurua, Olatz Pavón Piquer, Pilar Plou Garcia, Paula Ortega Rezola, Antia Osorio Lopez, Isabel de la Calle Gil, Rosalía Navarro Casado, Peter, Adamove, Roser Bayona Domenge, Francho Miguel Blasco Blasco, Adriana Alexandra Rueda Villamizar, Maria Antonia Perelló Llaneras, Jose Ignacio García-Sánchez, Laura Fernandez Téllez, Sara García Zamorano, Natalia Gijón Herreros, Andrea Rodriguez Esteve, Pablo Monedero Rodríguez, Isabel García Trigo, Agustín, Alcaraz, Andrea Lara Jiménez, Iñigo, Rubio, Nuria, García, Raquel, Callejas, Angel Manuel Candela Toha, Eli, Claros, Pilar, Cobeta, Pascual, Crespo, Trini, Dorado, Elena, Elías, Javier, Felices, Diego, Gil, María, Gómez, Nuria, Mané, María, Martín, Adolfo, Martínez, Lucía, Pereira, Alberto Balvis Noemí Samaranch, Ana, Serrano, Carlos, Tiscar, Judith, Villahoz, Patricia Galán Menéndez, Elena, Cardona, Anna, Conesa, Veronica, Estepa, Patricia, Galán, Laura Llinares Espí, Yuri Loaiza Aldeán, Susana, Manrique, Víctor Morales Ariza, Laura Villarino Villa, Elfayadh Saidahmed Mohamed Amed Suliman, Hytham, Hamid, Ahmed Mohamed Ibrahim, Modather Mohamed Saeed, Orhan Sungur Mukadder, Demet, Altun, Nur, Canbolat, Müşerref Beril Dinçer, Tulay Özkan Seyhan, Serap Aktaş Yıldırım, Müzeyyen, İyigün, Davut, Yapıcı, Levent, Özdemir, Aslinur, Sagun, Neval, Boztug, Yesim, Cetintas, Bora, Dinc, Emel, Gündüz, Hakkı, Ünlügenç, Demet Lafli Tunay, Deniz, Karakaya, Burhan, Dost, Ozgur, Komurcu, Özlem Korkmaz Dilmen, Eren Fatma Akcil, Yusuf, Tunali, Gülay, Ok, Eda Tok Alsina, Özge, Hakli, Cengiz, Polat, Namigar, Turgut, Nurcan, Kızılcık, Özge, Köner, Öznur, Şen, Nurdan, Aydin, Burcu, Basaran, Emre Sertac Bingul, Yavuz, Gürkan, Kamil, Darcin, Semra, Ugur, Kemal Tolga Saracoglu, Asli, Demir, Özgök, Aysegül, Eda, Balci, Behic, Girgin, Aygun, Guler, Ümit, Karadeniz, Nihal, Özaslan, Yigit Özay Hülya, Namik, Ozcan, Aysun, Postaci, Mehmet, Sahap, Nevriye, Salman, Özlem, Sağır, Bulent, Atik, Murat, Bicakcioglu, Hafize Fisun Demir, Ugün, Fatih, Nazan, Kocaoglu, Hüseyin Ilksen Toprak, Duygu Demiröz Aslan, Yusuf Ziya Colak, Mustafa Soner Ozcan, Mehmet, Yilmaz, Umran, Karaca, Sevtap Hekimoglu Sahin, Özlem Ersoy Karka, Gizem Demir Şenoğlu, Süheyla Erkoç Karadağ, Neslihan, Alkis, Volkan, Baytaş, Engin, Erturk, Ali, Akdogan, Ahmet, Besir, Dilek, Kutanis, Sedat, Saylan, Ersagun, Tugcugil, Pinar, Ayvat, Berrin, Günaydın, Beyza Mehri Büyükgebiz, Omer Faruk Boran, Feyza, Calisir, Yavuz, Orak, Bahar Kuvaki Balkan, Sibel, Büyükcoban, Erol, Gökel, Sakize Ferim Günenc, Sule, Özbilgin, Suna, Göre, Selcan, Akesen, Seda, Cansabuncu, Natalia, Momot, Anna, Panchenko, Jean-Francois, Pittet, Kristen, Rutledge, Tıp Fakültesi, Weiss, R, Saadat-Gilani, K, Kerschke,L, Wempe,C, Meersch, M, Zarbock, A, Cortegiani, A, and Ippolito, M

Subjects
Epidemiology, urologic and male genital diseases, acute renal failure, Adult Intensive & Critical Care, Anaesthesia, Cohort Studies, surgery, chronic renal failure, Humans, Multicenter Studies as Topic, Prospective Studies, adult intensive & critical care, urogenital system, Incidence, General Medicine, Acute Kidney Injury, female genital diseases and pregnancy complications, critical care, Renal Replacement Therapy, Observational Studies as Topic, epidemiology, Acute Renal Failure, Surgery, adult intensive &amp, Chronic Renal Failure
Abstract

Sağır, Özlem (Balikesir Author), Introduction More 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 analysis EPIS-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 dissemination EPIS-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 number NCT04165369. ©

Published
2021

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