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

Abstract

IntroductionAcute 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 analysisWe 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 disseminationThe 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 numberNCT03244514.

Impact of AKI care bundles on kidney and patient outcomes in hospitalized patients: a systematic review and meta-analysis

“…The content of the used AKI care bundles varied largely; components of each bundle are described in Table 2. The KDIGO bundle was most frequently used [ 8 , 20 , 22 , 26 , 30 , 32 , 35 ], often in association with biomarker-guided strategies. There was a high variability in overall compliance to the care bundle, ranging from 8 to 100%.…”

“…In 2012, the KDIGO working group made recommendations to implement an AKI care bundle routinely to reduce postoperative AKI in high-risk patients [ 4 ]. Küllmar and colleagues investigated the compliance with the KDIGO recommendations in routine clinical practice and found low compliance (5.3%) [ 30 ]. Compliance to the bundle could be improved by using an interruptive alert which demands to complete an electronic care bundle [ 29 , 39 ].…”

The Combination of SOFA Score and Urinary NGAL May Be an Effective Predictor for Ventilator Dependence among Critically Ill Surgical Patients: A Pilot Study

“…Furthermore, the rise of serum creatinine is usually delayed upon renal injury, and it did not provide insight into the location, severity, and pathological process of kidney dysfunction [ 30 ]. Fortunately, novel biomarkers predictive of renal dysfunction are emerging, and they exhibit the ability to detect acute kidney injury prior to the escalation of serum creatinine [ 31 , 32 ].…”

Molecular and clinical signatures in Acute Kidney Injury define distinct subphenotypes that associate with death, kidney, and cardiovascular events

“…Biomarkers reflective of key biological pathways such as kidney injury, inflammation, and health have emerged over the past 10 years showing their potential to anticipate the diagnosis of acute kidney injury (AKI) and forecast adverse outcomes in this population including disease duration, dialysis needs, and mortality. 7,8 Furthermore, among CKD patients, some of these biomarkers have been demonstrated to strongly predict the advent of end-stage kidney disease (ESKD) in patients with and without diabetes mellitus. [9][10][11][12][13][14][15] However, their ability to outperform to less expensive and routinely collected laboratory tests such as creatinine and urine albumin-tocreatinine ratio (uACR) has been questioned.…”