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1. 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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2. 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

3. Efficacy and Safety of Fosmidomycin–Piperaquine as Nonartemisinin-Based Combination Therapy for Uncomplicated Falciparum Malaria: A Single-Arm, Age De-escalation Proof-of-Concept Study in Gabon

Author

Ayola A. Adegnika, Moritz Sievers, Lena Flohr, Michael Ramharter, Thirumalaisamy P. Velavan, Luzia Veletzky, Benjamin Mordmüller, David Hutchinson, Peter G. Kremsner, Bertrand Lell, Joerg J. Moehrle, Lumeka Kabwende, Lilian Endamne, Chiara Cattaneo, Johannes Mischlinger, Mirjam Groger, Stephan Duparc, Rella Zoleko Manego, Jonathan Remppis, Ghyslain Mombo-Ngoma, Johanna Kim, and Felix Lötsch

Subjects
Adult, Male, 0301 basic medicine, Microbiology (medical), medicine.medical_specialty, Adolescent, Combination therapy, fosmidomycin, Plasmodium falciparum, 030106 microbiology, malaria, Polymerase Chain Reaction, Proof of Concept Study, QT interval, Antimalarials, Young Adult, 03 medical and health sciences, Pharmacotherapy, Fosfomycin, Interquartile range, Internal medicine, Piperaquine, parasitic diseases, medicine, Humans, Gabon, Malaria, Falciparum, Child, Adverse effect, Articles and Commentaries, business.industry, Age Factors, Infant, Middle Aged, Combined Modality Therapy, Artemisinins, Confidence interval, piperaquine, Treatment Outcome, 030104 developmental biology, Infectious Diseases, Tolerability, Child, Preschool, Quinolines, Drug Therapy, Combination, Female, business
Abstract

Fosmidomycin–piperaquine is being developed as nonartemisinin-based combination therapy to meet the challenge of emerging artemisinin resistance. The combination appeared to have high efficacy and be safe and well tolerated despite observed transient changes in electrocardiogram with prolongation of the QT interval., Background Fosmidomycin–piperaquine is being developed as nonartemisinin-based combination therapy to meet the challenge of emerging artemisinin resistance. Methods The study was a phase 2, single-arm, proof-of-concept study of the efficacy, tolerability, and safety of fosmidomycin–piperaquine for the treatment of uncomplicated Plasmodium falciparum monoinfection in Gabon. Adults and children of both sexes with initial parasite counts between 1000 and 150000/µL received oral treatment with fosmidomycin (twice daily doses of 30 mg/kg) and piperaquine (once daily dose of 16 mg/kg) for 3 days and followed-up for 63 days. The primary efficacy endpoint was the per-protocol polymerase chain reaction (PCR)–corrected day 28 adequate clinical and parasitological response (ACPR). Results One hundred patients were enrolled. The PCR-corrected day 28 ACPR rate was 83/83, or 100% (95% confidence interval, 96–100). Fourteen patients had asexual parasitaemia between day 28 and day 63; all were typed by PCR as new infections. Fosmidomycin–piperaquine therapy led to rapid parasite clearance (median, 36 hours; interquartile range [IQR], 6–60) and fever clearance time (median, 12 hours; IQR, 6–48). The electrocardiogram assessments showed 2 patients with prolonged QT interval >500 msec following study drug administration. The majority of adverse events affected the gastrointestinal and respiratory tracts and were transient and mild to moderate in severity. Conclusions This is the first report of the use of the combination fosmidomycin–piperaquine. The combination appeared to have high efficacy and be safe and well tolerated despite observed transient changes in electrocardiogram with prolongation of the QT interval. Clinical Trials Registration. NCT02198807.

Published
2017
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4. Prospective Clinical Trial Assessing Species-Specific Efficacy of Artemether-Lumefantrine for the Treatment of Plasmodium malariae, Plasmodium ovale, and Mixed Plasmodium Malaria in Gabon

Author

Michael Ramharter, Johannes Mischlinger, Mirjam Groger, Anna Klicpera, Selidji T Agnandji, Albert Lalremruata, Pierre-Blaise Matsiegui, Benjamin Mordmüller, Luzia Veletzky, Ayola A. Adegnika, Chiara Cattaneo, Rella Zoleko-Manego, Johanna Kim, Jonathan Remppis, Ghyslain Mombo-Ngoma, Peter G. Kremsner, Lena Flohr, and Lilian Endamne

Subjects
Adult, Male, medicine.medical_specialty, Artemether/lumefantrine, Adolescent, 030231 tropical medicine, Plasmodium ovale, Plasmodium malariae, Clinical Therapeutics, 03 medical and health sciences, Antimalarials, Young Adult, 0302 clinical medicine, Internal medicine, parasitic diseases, medicine, Humans, Pharmacology (medical), 030212 general & internal medicine, Gabon, Prospective cohort study, Adverse effect, Child, Pharmacology, Lumefantrine, biology, business.industry, medicine.disease, biology.organism_classification, Clinical trial, Infectious Diseases, Tolerability, Child, Preschool, Female, Artemether, business, Malaria, medicine.drug
Abstract

Treatment recommendations for Plasmodium malariae and Plasmodium ovale malaria are largely based on anecdotal evidence. The aim of this prospective study, conducted in Gabon, was to systematically assess the efficacy and safety of artemether-lumefantrine for the treatment of patients with uncomplicated P. malariae or P. ovale species monoinfections or mixed Plasmodium infections. Patients with microscopically confirmed P. malariae , P. ovale , or mixed-species malaria with at least one of these two Plasmodium species were treated with an oral, fixed-dose combination of artemether-lumefantrine for 3 consecutive days. The primary endpoints were per-protocol PCR-corrected adequate clinical and parasitological response (ACPR) on days 28 and 42. Tolerability and safety were recorded throughout the follow-up period. Seventy-two participants (42 male and 30 female) were enrolled; 62.5% of them had PCR-corrected mixed Plasmodium infections. Per protocol, PCR-corrected ACPR rates were 96.6% (95% confidence interval [CI], 91.9 to 100) on day 28 and 94.2% (95% CI, 87.7 to 100) on day 42. Considering Plasmodium species independently from their coinfecting species, day 42 ACPR rates were 95.5% (95% CI, 89.0 to 100) for P. falciparum , 100% (exact CI, 84.6 to 100) for P. malariae , 100% (exact CI, 76.8 to 100) for P. ovale curtisi , and 90.9% (95% CI, 70.7 to 100) for P. ovale wallikeri . Study drug-related adverse events were generally mild or moderate. In conclusion, this clinical trial demonstrated satisfying antimalarial activity of artemether-lumefantrine against P. ovale wallikeri , P. ovale curtisi , P. malariae , and mixed Plasmodium infections, with per-protocol efficacies of 90% to 100% and without evident tolerability or safety concerns. (This trial was registered in the clinical study database ClinicalTrials.gov under the identifier NCT02528279.)

Published
2017

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