TY - JOUR
T1 - Biomarker-guided implementation of the KDIGO guidelines to reduce the occurrence of acute kidney injury in patients after cardiac surgery (PrevAKI-multicentre)
T2 - protocol for a multicentre, observational study followed by randomised controlled feasibility trial
AU - Küllmar, Mira
AU - Massoth, Christina
AU - Ostermann, Marlies
AU - Campos, Sara
AU - Grau Novellas, Neus
AU - Thomson, Gary
AU - Haffner, Michael
AU - Arndt, Christian
AU - Wulf, Hinnerk
AU - Irqsusi, Marc
AU - Monaco, Fabrizio
AU - Di Prima, Ambra
AU - Garcia Alvarez, Mercedes
AU - Italiano, Stefano
AU - Cegarra Sanmartin, Virginia
AU - Kunst, Gudrun
AU - Nair, Shrijit
AU - L'acqua, Camilla
AU - Hoste, Eric A.J.
AU - Vandenberghe, Wim
AU - Honore, Patrick
AU - Kellum, John
AU - Forni, Lui
AU - Grieshaber, Philippe
AU - Weiss, Raphael
AU - Gerss, Joachim
AU - Wempe, Carola
AU - Meersch, Melanie
AU - Zarbock, Alexander
PY - 2020/4/6
Y1 - 2020/4/6
N2 - Introduction Acute kidney injury (AKI) is a frequent complication after cardiac surgery with adverse short-term and long-term outcomes. Although prevention of AKI (PrevAKI) is strongly recommended, the optimal strategy is uncertain. The Kidney Disease: Improving Global Outcomes (KDIGO) guideline recommended a bundle of supportive measures in high-risk patients. In a single-centre trial, we recently demonstrated that the strict implementation of the KDIGO bundle significantly reduced the occurrence of AKI after cardiac surgery. In this feasibility study, we aim to evaluate whether the study protocol can be implemented in a multicentre setting in preparation for a large multicentre trial. Methods and analysis We plan to conduct a prospective, observational survey followed by a randomised controlled, multicentre, multinational clinical trial including 280 patients undergoing cardiac surgery with cardiopulmonary bypass. The purpose of the observational survey is to explore the adherence to the KDIGO recommendations in routine clinical practice. The second phase is a randomised controlled trial. The objective is to investigate whether the trial protocol is implementable in a large multicentre, multinational setting. The primary endpoint of the interventional part is the compliance rate with the protocol. Secondary endpoints include the occurrence of any AKI and moderate/severe AKI as defined by the KDIGO criteria within 72 hours after surgery, renal recovery at day 90, use of renal replacement therapy (RRT) and mortality at days 30, 60 and 90, the combined endpoint major adverse kidney events consisting of persistent renal dysfunction, RRT and mortality at day 90 and safety outcomes. Ethics and dissemination The PrevAKI multicentre study has been approved by the leading Research Ethics Committee of the University of Münster and the respective Research Ethics Committee at each participating site. The results will be used to design a large, definitive trial. Trial registration number NCT03244514.
AB - Introduction Acute kidney injury (AKI) is a frequent complication after cardiac surgery with adverse short-term and long-term outcomes. Although prevention of AKI (PrevAKI) is strongly recommended, the optimal strategy is uncertain. The Kidney Disease: Improving Global Outcomes (KDIGO) guideline recommended a bundle of supportive measures in high-risk patients. In a single-centre trial, we recently demonstrated that the strict implementation of the KDIGO bundle significantly reduced the occurrence of AKI after cardiac surgery. In this feasibility study, we aim to evaluate whether the study protocol can be implemented in a multicentre setting in preparation for a large multicentre trial. Methods and analysis We plan to conduct a prospective, observational survey followed by a randomised controlled, multicentre, multinational clinical trial including 280 patients undergoing cardiac surgery with cardiopulmonary bypass. The purpose of the observational survey is to explore the adherence to the KDIGO recommendations in routine clinical practice. The second phase is a randomised controlled trial. The objective is to investigate whether the trial protocol is implementable in a large multicentre, multinational setting. The primary endpoint of the interventional part is the compliance rate with the protocol. Secondary endpoints include the occurrence of any AKI and moderate/severe AKI as defined by the KDIGO criteria within 72 hours after surgery, renal recovery at day 90, use of renal replacement therapy (RRT) and mortality at days 30, 60 and 90, the combined endpoint major adverse kidney events consisting of persistent renal dysfunction, RRT and mortality at day 90 and safety outcomes. Ethics and dissemination The PrevAKI multicentre study has been approved by the leading Research Ethics Committee of the University of Münster and the respective Research Ethics Committee at each participating site. The results will be used to design a large, definitive trial. Trial registration number NCT03244514.
KW - acute renal failure
KW - adult intensive & critical care
KW - cardiac surgery
UR - http://www.scopus.com/inward/record.url?scp=85083071729&partnerID=8YFLogxK
U2 - 10.1136/bmjopen-2019-034201
DO - 10.1136/bmjopen-2019-034201
M3 - Article
C2 - 32265240
AN - SCOPUS:85083071729
SN - 2044-6055
VL - 10
JO - BMJ Open
JF - BMJ Open
IS - 4
M1 - e034201
ER -
