EPIdemiology of Surgery-Associated Acute Kidney Injury (EPIS-AKI): Study protocol for a multicentre, observational trial
Date
2021Author
Weiss R,Saadat-Gilani K,Kerschke L,Wempe C,Meersch M,Zarbock A,Makhloufi H,Cherak A,Ghanem LL,Gouaglia Z,Guadouri DN,Hama FN,Kara M,Saadi O,Sakhraoui R,Bourou F,Cherifi A,Sadaoui RG,Ouyahia A,Ouahab I,Bouaoud S,Abdoun M,Tidjane A,Tabeti B,Boudjenan-Serradj N,Rivera CJ,Cabrer P,Corso J,García JP,Idarraga S,Montoya C,Figueroa R,Aldana E,Torrado MA,Peng K,Ma ZM,Yang YF,Zhu YJ,Sklienka P,Frelich M,Jarkulis V,Sevcik P,Vodicka V,Elbahnasawy MG,Elsalhawy S,Motawea S,Othman Z,Sahma M,Nafea AM,Ahmed N,Attia DA,Emara MM,Bonna MM,Gabr MA,Tarbay AI,Abdehaleem IA,Mohamed EE,Eldeeb AM,Abbas AM,Magdy JA,Hamed ZH,Osman HM,Abbas MS,Joannes-Boyau O,Barraud N,Berthelot C,Camus T,Dahmi A,Defaye M,Derville S,El-Boustani Y,Deloge E,Jacob H,Monziols S,Priem F,Robin JJ,Legros V,Floch T,Muccio S,Geneve C,Legouge ML,Mauny ST,Mfam W,Pascot L,Aveline C,Chartier M,Duteurtre B,Gautier JF,Cousin AL,Vautier P,Nadaud J,Begel N,Chekirine CA,Derlon V,Grein E,Lehair MA,Magazzeni L,Magazzeni P,Potter C,Roth C,Voivret F,Rimmelé T,Cerro V,Suria S,Elmawieh J,Stoclin A,Cirenei C,Andrieu G,Couloumy S,Falcone J,Fajardy M,Gagneuil A,Girardet E,Mazereeuw A,Ponsonnard S,Egreteau PY,Bertel M,Bocher S,Carn V,Guen LL,Loup GL,Lefevre M,Ichai C,Diop A,Jean-Michel V,Devlieger S,Duthoit J,El Kadiri M,Léger M,Cassisa V,Lasocki S,Masson C,Rineau E,Verrier P,Coquerel A,Montravers P,Atchade E,Rochon CE,Delerue C,Quentin V,Latry V,Queixalos N,Cottenceau V,Braun T,Bouzoubaa S,Christ B,Geiger A,Gomille J,Kieffer V,Mangeant S,Prochilo C,Schmitt C,Skwirba S,Grand H,Boury F,Mayeur N,Pasquie M,Garçon P,Bruckert V,Arnould V,Bonciu M,Chapelle T,Facchino L,Fagot-Gandet F,Iachim A,Mannu E,Perus O,Plattier R,Rozier R,Pradel G,Boudinaud M,Hausermann MH,Nguyen MH,Ramorasata A,Barreau A,Boivin AH,Ravry C,Mottard N,Beuvelot J,Bossion FP,Desebbe O,Zarbock A,Dörr C,von Groote TC,Küllmar M,Massoth C,Meersch M,Saadat-Gilani K,Weiss R,Wempe C,Ziemann S,Grüßer L,Kowark A,Wittig P,Brandenburger T,Dimski T,Döhmen N,Huthmann L,Kaierle D,Pelletier C,Schleß M,Hohn A,Cleophas S,Haunhorst S,Jansen M,Schmitt A,Soisch J,Sturm K,Rosenberger P,Bendig A,Flohr L,Häberle H,Hofmann P,Kuhle J,Leser NM,Pfister K,Prohaska S,Sennholz F,Stetz L,Weber K,Stehr S,Klaus S,Sadlo M,Boschin M,Sengelhoff C,Göbel UM,Haaker JG,Göttker CK,Gründel M,Heringlake M,Baumgärtel R,Berggren A,Gülzow M,Muras L,Paarmann H,Thal S,Bentley A,El-Masri D,Sebastiani A,Arnaoutoglou E,Ntalouka M,Stratigopoulou P,Analytis A,Mavrommatis E,Tzimas P,Karakosta A,Pantazi D,Dimakopoulou A,Dimitropoulou K,Ioannidis O,Jalaawiy H,Anwar A,Hashim HT,Aldawoody HI,Cortegiani A,Catalisano G,Ingoglia G,Ippolito M,De Rosa S,Cattin L,Bianchin A,Barone M,Paternoster G,Cutuli SL,Russo A,Sollazzi L,Cascarano L,Antonelli M,Aceto P,Romanò B,Spadaro S,Tripodi VF,Rossi M,Scappatura R,Vadalà MC,Fiume D,Strano MT,Oddo G,Santorsola C,Hussain BA,Alnaser AR,Ghassan AH,Hasanein K,Theab M,Shin S,Jung S,Lee K,Jung SM,Baek J,Elhadi MK,Aldressi WW,Abuzeid I,Albaraesi M,Aldressi S,Khalel W,Abdulwahed E,Abujrad AA,Almaghrabi A,Alteleeb M,Alshareea EA,Biala MI,Deeknah A,Gheddim DA,Ghmagh R,Ikhrays NS,Sinan M,Soula E,Bahroun SG,Derwish K,Mohamed AM,Younes ES,Al Islam Benjouira R,Aliwa M,Altashani NA,Alteb MO,Msherghi A,Alagelli F,Albarouni S,Albishti A,Aljamal S,Alsori M,Ekhuja T,Elzwai S,Ghula M,Mustafa T,Tuwaib A,Zriba H,Agilla HM,Rafanomezantsoa TA,Podesta AM,Bonnici DM,Pirotta T,López GA,Mijovska MM,Davitkovska T,Gavrilovska A,Lukikj S,Vesova M,Zafirova D,Amro S,Hajjaj BN,Alkhazendar M,Barakat Y,Elejla SA,Elhissi A,Khader A,Salem A,de Freitas Regufe R,de Oliveira Eloy AF,Perdigão LM,Grigoriev E,Ivkin A,Kornelyuk R,Yaroustovsky M,Abramyan M,Komardina E,Lesteva N,Aybazova M,Kumykova E,Lesina S,Rybakov G,Shestov A,Barmou AA,Ahmed BL,Eliyas AM,Emadeldin Y,Kaserer A,Castellucci C,Rössler J,Akbas S,Petrun AM,Gregorcic I,Sok V,Cicak R,Bárcena E,Guisado A,Wi I,Melchor JR,Becerra-Bolaños Á,Cabrera-Doreste S,Domínguez-Arbelo A,Delgado-Alonso MC,Muiño-Palomar V,Rodríguez-Pérez A,Estévez JM,Munoz MB,Matas JM,Palao SP,Quirós MD,Teslev AC,Argilaga M,Campos M,Bainac A,Batalla A,Alvarez MG,Giné M,Herránz G,Hinojal I,Ejea ML,de la Rosa Ruiz N,Abasolo MG,Acuna CR,Zaranton II,Mendigurenmurua A,Sanz MJ,de la Fuente EO,Vaquero MP,Iglesias AS,Mieres AU,Urrestizala AU,Ferreira L,Lobato F,Sevilla MA,Erazo A,Miró P,Sabaté S,Vernetta D,Perez AA,Pagola MA,Paulis BC,del Val Peciña E,Odriozola AG,Aizpurua AL,Piquer OP,Garcia PP,Rezola PO,Lopez AO,de la Calle Gil I,Casado RN,Adamove P,Domenge RB,Blasco FM,Villamizar AA,Llaneras MA,García-Sánchez JI,Téllez LF,Zamorano SG,Herreros NG,Esteve AR,Rodríguez PM,Trigo IG,Alcaraz A,Jiménez AL,Rubio I,García N,Callejas R,Toha AM,Claros E,Cobeta P,Crespo P,Dorado T,Elías E,Felices J,Gil D,Gómez M,Mané N,Martín M,Martínez A,Pereira L,Samaranch AB,Serrano A,Tiscar C,VillaHoz J,Menéndez PG,Cardona E,Conesa A,Estepa V,Galán P,Espí LL,Aldeán YL,Manrique S,Ariza VM,Villa LV,Suliman ES,Hamid H,Ibrahim AM,Saeed MM,Mukadder OS,Altun D,Canbolat N,Dinçer MB,Seyhan TÖ,Yildirim SA,Iyigün M,Yapici D,Özdemir L,Sagun A,Boztug N,Cetintas Y,Dinc B,Gündüz E,Ünlügenç H,Tunay DL,Karakaya D,Dost B,Komurcu O,Akcil EF,Dilmen ÖK,Tunali Y,Ok G,Alsina ET,Hakli Ö,Polat C,Turgut N,Kizilcik N,Köner Ö,Sen Ö,Aydin N,Basaran B,Bingul ES,Gürkan Y,Darcin K,Ugur S,Saracoglu KT,Demir A,Aysegül Ö,Balci E,Girgin B,Guler A,Karadeniz Ü,Özaslan N,Hülya YÖ,Ozcan N,Postaci A,Sahap M,Salman N,Sagir Ö,Atik B,Bicakcioglu M,Demir HF,Fatih U,Kocaoglu N,Toprak HI,Aslan DD,Colak YZ,Ozcan MS,Yilmaz M,Karaca U,Sahin SH,Karka ÖE,Senoglu GD,Karadag SE,Alkis N,Baytas V,Akdogan A,Besir A,Erturk E,Kutanis D,Saylan S,Tugcugil E,Ayvat P,Günaydin B,Büyükgebiz BM,Boran OF,Calisir F,Orak Y,Balkan BK,Büyükcoban S,Gökel E,Günenc SF,Özbilgin S,Göre S,Akesen S,Cansabuncu S,Momot N,Panchenko A,Pittet JF,Rutledge K,Investigators TE
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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. ©
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