Biomarker-guided implementation of the KDIGO guidelines to reduce the occurrence of acute kidney injury in patients after cardiac surgery (PrevAKI-multicentre): protocol for a multicentre, observational study followed by randomised controlled feasibility trial
Por:
Kullmar, M, Massoth, C, Ostermann, M, Campos, S, Novellas, NG, Thomson, G, Haffner, M, Arndt, C, Wulf, H, Irqsusi, M, Monaco, F, Di Prima, A, Alvarez, MG, Italiano, S, SanMartin, VC, Kunst, G, Nair, S, L'Acqua, C, Hoste, EAJ, Vandenberghe, W, Honore, P, Kellum, J, Forni, L, Grieshaber, P, Weiss, R, Gerss, J, Wempe, C, Meersch, M, Zarbock, A
Publicada:
1 abr 2020
Resumen:
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.
Filiaciones:
Kullmar, M:
Univ Klinikum Munster, Anesthesiol Intens Care & Pain Med, Munster, Nordrhein Westf, Germany
Massoth, C:
Univ Klinikum Munster, Anesthesiol Intens Care & Pain Med, Munster, Nordrhein Westf, Germany
Ostermann, M:
Kings Coll London, Guys & St Thomas Hosp, Dept Crit Care, London, England
Campos, S:
Kings Coll London, Guys & St Thomas Hosp, Dept Crit Care, London, England
Novellas, NG:
Kings Coll London, Guys & St Thomas Hosp, Dept Crit Care, London, England
Thomson, G:
Kings Coll London, Guys & St Thomas Hosp, Dept Crit Care, London, England
Haffner, M:
Kings Coll London, Guys & St Thomas Hosp, Dept Crit Care, London, England
Arndt, C:
Univ Hosp Marburg, Dept Anesthesiol & Operat Intens Care, Marburg, Germany
Wulf, H:
Philipps Univ Marburg, Anesthesiol & Intens Care Med, Fachbereich Med, Marburg, Germany
Irqsusi, M:
Philipps Univ Marburg, Dept Cardiothorac Surg, Fachbereich Med, Marburg, Germany
Monaco, F:
Sci Inst San Raffaele, Intens Care & Anesthesia Unit, Milan, Italy
Di Prima, A:
Sci Inst San Raffaele, Intens Care & Anesthesia Unit, Milan, Italy
Alvarez, MG:
Hosp Santa Creu & Sant Pau, Dept Anesthesiol, Barcelona, Catalunya, Spain
Italiano, S:
Hosp Santa Creu & Sant Pau, Dept Anesthesiol, Barcelona, Catalunya, Spain
SanMartin, VC:
Hosp Santa Creu & Sant Pau, Dept Anesthesiol, Barcelona, Catalunya, Spain
Kunst, G:
Kings Coll London, Dept Anesthesia Crit Care & Pain, London, England
Nair, S:
Kings Coll London, Dept Anesthesia Crit Care & Pain, London, England
L'Acqua, C:
Ctr Cardiol Monzino IRCCS, Dept Anesthesia & Crit Care, Milan, Lombardia, Italy
Hoste, EAJ:
Univ Ghent, ICU, Ghent, Belgium
Vandenberghe, W:
Univ Ghent, ICU, Ghent, Belgium
Honore, P:
CHU Brugmann, Dept Intens Care, Brussels, Belgium
Kellum, J:
Univ Pittsburgh, Ctr Crit Care Nephrol, Dept Crit Care Med, Pittsburgh, PA USA
Forni, L:
Royal Surrey Cty Hosp NHS Trust, Dept Intens Care Med, Guildford, Surrey, England
Grieshaber, P:
Justus Liebig Univ Giessen, Dept Cardiac Surg, Fachbereich Med, Giessen, Hessen, Germany
Weiss, R:
Univ Hosp Munster, Dept Anaesthesiol, Munster, Germany
Gerss, J:
Westfalische Wilhelms Univ Munster, Inst Biostat & Clin Res, Munster, Germany
Wempe, C:
Univ Klinikum Munster, Anesthesiol Intens Care & Pain Med, Munster, Nordrhein Westf, Germany
Meersch, M:
Univ Klinikum Munster, Anesthesiol Intens Care & Pain Med, Munster, Nordrhein Westf, Germany
Zarbock, A:
Univ Klinikum Munster, Anesthesiol Intens Care & Pain Med, Munster, Nordrhein Westf, Germany
Gold, Green Published
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