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.

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.

Fondaparinux as a safe alternative for managing heparin-induced thrombocytopenia in postoperative cardiac surgery patients.

OBJECTIVE: Heparin-induced thrombocytopenia (HIT) is a rare but severe prothrombotic disorder of heparin treatment that leads to a decline in platelet count and thrombotic complications. If HIT is suspected, then heparin should be stopped and an alternative anticoagulant started. Fondaparinux is a factor Xa-inhibitor that is not FDA-approved for this condition, but preliminary experience in HIT patients has been reported in the literature. The present study describes an experience of anticoagulation management with fondaparinux in postoperative cardiac surgery patients. DESIGN: Retrospective study. SETTING: Tertiary hospital. PARTICIPANTS: Patients who had undergone cardiac surgery from October 2009 to June 2012. INTERVENTIONS: After HIT was suspected clinically, PaGIA and ELISA test were performed in all patients to diagnose HIT. In the patients included, anticoagulation was managed with a low dose of fondaparinux and daily monitoring of platelet count and anti-Xa level. MEASUREMENTS AND MAIN RESULTS: Of a total of 1,338 postoperative cardiac surgery patients, 15 patients were included (1.1%). Twelve of the 15 patients with HIT presented with renal failure and were under continuous renal replacement therapy. Two major bleeding events occurred during fondaparinux treatment, although platelet count and anti-Xa activity remained within the normal range. No thrombotic episodes were diagnosed. CONCLUSION: With daily monitoring of anti-Xa activity, fondaparinux appeared to be a good alternative to heparin in the study group; however, randomized clinical trials are needed to establish the safety and efficacy of this drug in critically ill, previously HIT patients.