Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial): study protocol for an international, prospective, randomised controlled multicentre trial
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....
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| Format: | Article |
| Language: | English |
| Published: |
BMJ Publishing Group
2023-03-01
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| Series: | BMJ Open |
| Online Access: | https://bmjopen.bmj.com/content/13/3/e070240.full |
| _version_ | 1797745118318428160 |
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| 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 Marion Leclercq-Rouget |
| author_facet | 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 Marion Leclercq-Rouget |
| collection | DOAJ |
| description | 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. |
| first_indexed | 2024-03-12T15:18:54Z |
| format | Article |
| id | doaj.art-65bd20d6df034715838a6f4f287c269e |
| institution | Directory Open Access Journal |
| issn | 2044-6055 |
| language | English |
| last_indexed | 2024-03-12T15:18:54Z |
| publishDate | 2023-03-01 |
| publisher | BMJ Publishing Group |
| record_format | Article |
| series | BMJ Open |
| spelling | doaj.art-65bd20d6df034715838a6f4f287c269e2023-08-11T07:35:08ZengBMJ Publishing GroupBMJ Open2044-60552023-03-0113310.1136/bmjopen-2022-070240Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial): study protocol for an international, prospective, randomised controlled multicentre trial Joachim Gerss0Javier Ripollés-Melchor1Emmanuel FutierMelanie Meersch2Carola WempeDetlef Kindgen-MillesAlexander Zarbock3Markus W HollmannSigismond LasockiThomas RimmeleTim Rahmel4Michael Adamzik5Hartmuth NowakIngeborg WeltersBrian Johnston6Ane Abad-motosAlfredo Abad-gurumetaMarc Moritz BergerDavide RicciMaurizio CecconiGudrun KunstChristian StoppeChristian Putensen7Marlies Ostermann8Sascha OttBrijesh PatelGabriele BaldiniAntoine LamblinKaren WilliamsElena ManciniChristian Arndt9Hinnerk Wulf10Marc IrqsusiWim Vandenberghe11John Kellum12Raphael Weiss13Jackie DonovanLui G ForniGiacomo MontiCéline Monard14Markus A WeigandThorsten BrennerUlrich JaschinskiCarlos LopezMaxime LegerEmmanuel RineauPhilipp SimonMaría Gómez-RojoLars BergmannAlicia WaiteSavino Spadaro15Alexander WolfAndrew SpenceSimon DublerAlexander PJ VlaarPatrick SchoberBen C Creagh-BrownNandor MarczinEmilio MasedaChristian StraussStefano Romagnoli16Christian NusshagUlrich Gobel17Ángel Candela-Toha18Jon SilversidesNuttha Lumlertgul19Khaschayar Saadat-Gilani20Vincent LegrosTimo Brandenburger21Thomas DimskiLaura HuthmannClaude PelletierManon SchleßPeter RosenbergerHelene HäberleJan Gerrit Haaker22Matthias GründelLucia Cattin23Laura Villarino VillaJuan Victor LorenteChristine Martin24Jan Larmann25Wolfgang BauerGiovanni BorghiBenjamin O’Brien26Thilo von Groote27Antoine Guillaume Schneider28Silvia De Rosa29Diego Parise30Alice Bernard31Paula Fernández-Valdes-Bango32Irene Romero Bhathal33A Suarez-de-la-Rica34Gianluca Villa35Raquel García-Álvarez36Antonio Siniscalchi37Richard Ellerkmann38Florian Espeter39Christian Porschen40Mahan Sadjadi41Michael StorckTobias BrixDana MeschedeWida AminiCarina StengerJulius FreytagJens BrandsMatthias UnterbergBritta MarkoFabian DusseWolfgang A WetschSandra E StollHendrik DrinhausBernd W BöttigerOnnen MörerLars-Olav HarnischRoswitha LubjuhnDaniel HeiseChristian BodeAndrea SauerKonrad PeukertLennart WildPhilippe KruseJan MenzenbachValbona MirakajSabine HermannStefanie DeckerMona Jung-KönigTobias HölleSarah DehneJörg ReutershanThomas PrüferStefan PielmeierIndra WimmelmeierMichaela ScholzAndrea ParisIsabel Christina Gallego ZapataHolger PohlNirmeen FayedKai DielmannEvelyn MartinTilo KochAlexander MückPhilipp DeetjenNgoc Bich MehlmannPeter M SpiethAndreas GüldnerAxel RandMaximillian RagallerMartin MirusRebecca BockholtMarc HerzogMaren Kleine-BrüggeneyAnt Isabelle CristianiMarion OhlMonica Vieira Da SilvaGilda Filipe de Castro RebloMatthias HiltyKatharina SpanausBenedetta MuraEleonora TerreniFrancesco MagiottiLorenzo TuriCristiana LaiciChiara CapozziAndrea CastelliMassimiliano GrecoAntonio MessinaGianluca CastellaniRomina AcetoVinicio DanziAlessandro RigobelloMassimo De CalMonica ZanellaGaetano ScaramuzzoRiccardo La RosaPaolo PrianiAlberto Volta CarloStefano TuriMartina Baiardo RedaelliMarilena MarmiereKittisak WeerapolchaiShelley LorahFabiola D’AmatoAneta BociekRosario LimBenjie CendredaReynaldo Dela CuestaEirini KosifidouZoka MilanJuliana FernandaEmma ClareyDaveena MeeksNicholas J LeesMarco ScaramuzziOrinta KviatkovskeAdam GlassChristine TurleyCharlotte QuinnSyeda HaiderAdam RossiterSyed NasserNed Gilbert-KawaiTatjana Besse-HammerEric HosteHannah SchaubroeckJan De WaeleJenni BreelEline de KlerkHarm-Jan de GroothLothar SchwarteAlexander LoerAlicia Ruiz-EscobarDiana Fernández-GarcíaNerea Gómez-PérezPascual Crespo-AlisedaCristina Cerro-ZaballosCristina Fernández-MartínEduardo Martín-MonteroAlejandro Suarez de la RicaHéctor Berges GutiérrezMaria del Pino Heredia PérezMaria de los Reyes Bellido FernándezLiena Izquierdo LópezJavier Valiente LourtauMa Angeles Ferre ColomerMa Azucena Pajares MonchoMaria Jesús Montero HernándezEsther Pérez SanchoSilvia Polo MatínezPedro Rivera SoriaMaider Puyada JáureguiHugo Rivera RamosMarta Antelo AdránRamón Adalia BartoloméPatricia Galán MenéndezLaura Llinares EspinYuri Santiago Loaiza AldeanVíctor MoralesArizaRosalía Navarro-PerezLuis Santé-SernaPedro de la Calle-ElguezabalRubén Sánchez-MartínInés De SotoPau Vallhonrat AlcántaraLaura Perelló CerdàGal·la Rouras HurtadoPaula Rodriguez NietoJohn Narros SiclunaAngel Molero MolineroJuan Pablo NoceteElena Murcia SánchezStanislas AbrardMarie-Luce ParrouffeFrank BidarLucie AupetitgendreUgo SchiffBertille PaquetteGaëlle SellierNathalie BorgnettaBenjamin BrochetThierry FlochJulien CoffinetMarion Leclercq-RougetInstitute of Biostatistics and Clinical Research, University of Münster, Munster, Nordrhein-Westfalen, GermanyDepartamento de Anestesia, Hospital Universitario Infanta Leonor, Madrid, SpainDepartment of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, North Rhine-Westphalia, GermanyDepartment of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, North Rhine-Westphalia, GermanyDepartment of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Knappschaftskrankenhaus, Ruhr University Bochum, Bochum, Nordrhein-Westfalen, GermanyDepartment of Anesthesiology, Intensive Care Medicine and Pain Therapy, University Hospital Knappschaftskrankenhaus, Ruhr University Bochum, Bochum, Nordrhein-Westfalen, Germany1 Department of Critical Care, Liverpool University Hospitals NHS Foundation Trust, Liverpool, UKDepartment of Anesthesiology and Surgical Intensive Care Medicine, Division of Intensive Care Medicine, Universitätsklinikum Bonn, Bonn, GermanyDepartment of Critical Care, King`s College London, Guy`s and St Thomas` Hospitals NHS Trust, London, London, UKAnesthesiology and Intensive Care Medicine, Philipps-Universitat Marburg Fachbereich Medizin, Marburg, GermanyAnesthesiology and Intensive Care Medicine, Philipps-Universitat Marburg Fachbereich Medizin, Marburg, GermanyDepartment of Intensive Care Medicine, Universiteit Gent, Gent, BelgiumCenter for Critical Care Nephrology, University of Pittsburgh, Pittsburgh, Pennsylvania, USADepartment of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, North Rhine-Westphalia, GermanyService d`Anesthésie-Réanimation, Hôpital Edouard Herriot, Lyon, Rhône-Alpes, FranceDepartment of Translational Medicine and for Romagna, St. Anne`s Archbishop Hospital, University of Ferrara, Ferrara, Emilia-Romagna, ItalyDepartment of Health Sciences, Section of Anesthesiology, Intensive Care and Pain Medicine, University of Florence; Department of Anesthesia and Intensive Care, Section of Oncological Anesthesia and Intensive Care, Azienda Ospedaliero-Universitaria Careggi, Florence, ItalyDepartment of Anesthesiology and Intensive Care, St Franziskus-Hospital Münster GmbH, Munster, Nordrhein-Westfalen, GermanyDepartment of Anesthesiology and Critical Care, Hospital Universitario Ramón y Cajal, Madrid, Madrid, SpainDepartment of Critical Care & Nephrology, Guy’s and St Thomas Hospital, London, UKDepartment of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, North Rhine-Westphalia, GermanyAnesthesiology and Critical Care Medicine, Heinrich Heine University Düsseldorf, Dusseldorf, Nordrhein-Westfalen, GermanyDepartment of Anesthesiology and Intensive Care, St Franziskus-Hospital Münster GmbH, Munster, Nordrhein-Westfalen, GermanyDepartment of Anesthesiology and Intensive Care Medicine, San Bortolo Hospital of Vicenza, Vicenza, Veneto, ItalyDepartment of Neurology, Zuckerberg San Francisco General Hospital and Trauma Center, San Francisco, California, USADepartment of Anaesthesia, Heidelberg University Hospital, Heidelberg University, Heidelberg, Baden-Württemberg, GermanyDepartment of Cardiac Anesthesiology and Intensive Care Medicine, Deutsches Herzzentrum Berlin, Charité Universitätsmedizin Berlin, Berlin, GermanyDepartment of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, North Rhine-Westphalia, GermanyAdult Intensive Care Unit, University Hospital of Lausanne, Lausanne, SwitzerlandDepartment of Anesthesiology and Intensive Care Medicine, San Bortolo Hospital of Vicenza, Vicenza, Veneto, ItalyDepartment of Anesthesiology and Critical Care, Hospital Universitario Ramón y Cajal, Madrid, Madrid, SpainDepartment of Anesthesiology and Intensive Care Medicine, University Hospital Tübingen, University of Tübingen, Tubingen, Baden-Württemberg, GermanyDepartamento de Anestesia, Hospital Universitario Infanta Leonor, Madrid, SpainDepartment of Anaesthesiology and Intensive Care Medicine, Consorci Parc de Salut MAR de Barcelona, Barcelona, Catalunya, SpainDepartment of Anesthesiology and Critical Care, Hospital Universitario Marques de Valdecilla, Santander, SpainDepartment of Health Sciences, Section of Anesthesiology, Intensive Care and Pain Medicine, University of Florence; Department of Anesthesia and Intensive Care, Section of Oncological Anesthesia and Intensive Care, Azienda Ospedaliero-Universitaria Careggi, Florence, ItalyDepartment of Anesthesia and Intensive Care, Hospital Universitario 12 de Octubre, Madrid, Comunidad de Madrid, SpainPostoperative and Abdominal Organ Transplant Intensive Care Unit, IRCCS Azienda Ospedaliero-Universitaria di Bologna Policlinico S Orsola, Bologna, Emilia-Romagna, ItalyDepartment of Anesthesiology, Intensive Care, Pain Medicine and Palliative Care Medicine, Hospital Dortmund, Dortmund, GermanyDepartment of Anesthesiology and Intensive Care Medicine, University Hospital Essen, Essen, Nordrhein-Westfalen, GermanyDepartment of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, North Rhine-Westphalia, GermanyDepartment of Anaesthesiology, Intensive Care and Pain Medicine, University Hospital Münster, Munster, North Rhine-Westphalia, GermanyIntroduction 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.https://bmjopen.bmj.com/content/13/3/e070240.full |
| spellingShingle | 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 Marion Leclercq-Rouget Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial): study protocol for an international, prospective, randomised controlled multicentre trial BMJ Open |
| title | Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial): study protocol for an international, prospective, randomised controlled multicentre trial |
| title_full | Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial): study protocol for an international, prospective, randomised controlled multicentre trial |
| title_fullStr | Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial): study protocol for an international, prospective, randomised controlled multicentre trial |
| title_full_unstemmed | Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial): study protocol for an international, prospective, randomised controlled multicentre trial |
| title_short | Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial): study protocol for an international, prospective, randomised controlled multicentre trial |
| title_sort | biomarker guided intervention to prevent acute kidney injury after major surgery bigpak 2 trial study protocol for an international prospective randomised controlled multicentre trial |
| url | https://bmjopen.bmj.com/content/13/3/e070240.full |
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