Biomarker-guided intervention to prevent acute kidney injury after major surgery (BigpAK-2 trial): study protocol for an international, prospective, randomised controlled multicentre trial.
Details
State: Public
Version: Final published version
License: CC BY-NC 4.0
Serval ID
serval:BIB_060F42F5AD1C
Type
Article: article from journal or magazin.
Collection
Publications
Institution
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.
Journal
BMJ open
Working group(s)
BigpAK-2 Investigators
Contributor(s)
Wempe C., Storck M., Brix T., Meschede D., Martin C., Amini W., Strauss C., Stenger C., Gründel M., Brenner T., Berger M.M., Freytag J., Dubler S., Brands J., Nowak H., Bergmann L., Unterberg M., Wolf A., Marko B., Kindgen-Milles D., Huthmann L., Schless M., Dimski T., Pelletier C., Dusse F., Wetsch W.A., Stoll S.E., Drinhaus H., Böttiger B.W., Mörer O., Harnisch L.O., Lubjuhn R., Heise D., Bode C., Sauer A., Peukert K., Wild L., Kruse P., Menzenbach J., Rosenberger P., Häberle H., Mirakaj V., Hermann S., Decker S., Weigand M.A., Jung-König M., Hölle T., Dehne S., Nusshag C., Reutershan J., Prüfer T., Pielmeier S., Wimmelmeier I., Scholz M., Paris A., Gallego Zapata I.C., Pohl H., Fayed N., Irqsusi M., Dielmann K., Martin E., Koch T., Simon P., Jaschinski U., Mück A., Deetjen P., Mehlmann N.B., Spieth P.M., Güldner A., Rand A., Ragaller M., Mirus M., Bockholt R., O'Brien B., Ott S., Herzog M., Kleine-Brüggeney M., Stoppe C., Cristiani A.I., Monard C., Ohl M., Silva MVD, Reblo GFC, Hilty M., Spanaus K., Mura B., Terreni E., Magiotti F., Turi L., Baldini G., Laici C., Mancini E., Ricci D., Capozzi C., Castelli A., Greco M., Messina A., Cecconi M., Castellani G., Aceto R., Cattin L., Danzi V., Rigobello A., Cal M., Zanella M., Scaramuzzo G., Rosa R., Priani P., Carlo A.V., Turi S., Monti G., Borghi G., Redaelli M.B., Marmiere M., Weerapolchai K., Lorah S., D'Amato F., Bociek A., Lim R., Cendreda B., Cuesta R.D., Kosifidou E., Milan Z., Kunst G., Fernanda J., Clarey E., Meeks D., Marczin N., Patel B., Donovan J., Lees N.J., Scaramuzzi M., Kviatkovske O., Spence A., Glass A., Silversides J., Turley C., Quinn C., Forni L.G., Haider S., Rossiter A., Nasser S., Creagh-Brown B.C., Welters I., Williams K., Waite A., Johnston B., Gilbert-Kawai N., Besse-Hammer T., Vandenberghe W., Hoste E., Schaubroeck H., Waele J., Hollmann M.W., Bauer W., Breel J., Klerk E., Vlaar A.P., Grooth H.J., Schober P., Schwarte L., Loer A., Lorente J.V., Ruiz-Escobar A., Fernández-García D., Abad-Motos A., Gómez-Pérez N., Abad-Gurumeta A., Crespo-Aliseda P., Gómez-Rojo M., Cerro-Zaballos C., Fernández-Martín C., Martín-Montero E., Rica A.S., López C., Maseda E., Gutiérrez H.B., Heredia Pérez MDP, Reyes Bellido Fernández M.L., López L.I., Lourtau J.V., Ferre Colomer M.A., Moncho MAP, Montero Hernández M.J., Sancho E.P., Matínez S.P., Soria P.R., Jáuregui M.P., Ramos H.R., Adrán M.A., Bartolomé R.A., Menéndez P.G., Villa L.V., Espin L.L., Loaiza Aldean Y.S., MoralesAriza V., Navarro-Perez R., Santé-Serna L., Calle-Elguezabal P., Sánchez-Martín R., Soto I., Alcántara P.V., Cerdà L.P., Hurtado G.R., Nieto P.R., Sicluna J.N., Molinero A.M., Nocete J.P., Sánchez E.M., Rimmelé T., Abrard S., Lamblin A., Parrouffe M.L., Bidar F., Futier E., Aupetitgendre L., Schiff U., Paquette B., Rineau E., Sellier G., Borgnetta N., Léger M., Lasocki S., Legros V., Brochet B., Floch T., Coffinet J., Leclercq-Rouget M.
ISSN
2044-6055 (Electronic)
ISSN-L
2044-6055
Publication state
Published
Issued date
27/03/2023
Peer-reviewed
Oui
Volume
13
Number
3
Pages
e070240
Language
english
Notes
Publication types: Journal Article
Publication Status: epublish
Publication Status: epublish
Abstract
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.
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.
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.
NCT04647396.
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.
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.
NCT04647396.
Keywords
Humans, Tissue Inhibitor of Metalloproteinase-2/urine, Prospective Studies, Biomarkers, Acute Kidney Injury/etiology, Acute Kidney Injury/prevention & control, Renal Replacement Therapy, Multicenter Studies as Topic, Acute renal failure, Adult intensive & critical care, Chronic renal failure, INTENSIVE & CRITICAL CARE, SURGERY
Pubmed
Web of science
Open Access
Yes
Create date
03/04/2023 13:29
Last modification date
25/01/2024 8:31
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