Fenoldopam to prevent renal replacement therapy after cardiac surgery. Design of the FENO-HSR study
نویسندگان
چکیده
INTRODUCTION Acute kidney injury requiring renal replacement therapy is a serious complication following cardiac surgery associated with poor clinical outcomes. Until now no drug showed nephroprotective effects. Fenoldopam is a dopamine-1 receptor agonist which seems to be effective in improving postoperative renal function. The aim of this paper is to describe the design of the FENO-HSR study, planned to assess the effect of a continuous infusion of fenoldopam in reducing the need for renal replacement therapy in patients with acute kidney injury after cardiac surgery. METHODS We're performing a double blind, placebo-controlled multicentre randomized trial in over 20 Italian hospitals. Patients who develop acute renal failure defined as R of RIFLE score following cardiac surgery are randomized to receive a 96-hours continuous infusion of either fenoldopam (0.025-0.3 µg/kg/min) or placebo. RESULTS The primary endpoint will be the rate of renal replacement therapy. Secondary endpoints will be: mortality, time on mechanical ventilation, length of intensive care unit and hospital stay, peak serum creatinine and the rate of acute renal failure (following the RIFLE score). CONCLUSIONS This trial is planned to assess if fenoldopam could improve relevant outcomes in patients undergoing cardiac surgery who develop acute renal dysfunction. Results of this double-blind randomized trial could provide important insights to improve the management strategy of patients at high risk for postoperative acute kidney injury.
منابع مشابه
The FENO-HSR study: details of statistical analyses
Corresponding author: Tizana Bove, MD Department of Anesthesia and Intensive Care San Raffaele Scientific Institute Via Olgettina, 60 – 20132 Milan, Italy e-mail: [email protected] Dear Editor, One of the most life threatening complication in critically ill patients is acute kidney injury (AKI) and no drug has evidence based medicine to support its use to reduce the incidence of renal replace...
متن کاملEffect of fenoldopam on use of renal replacement therapy among patients with acute kidney injury after cardiac surgery: a randomized clinical trial.
IMPORTANCE No effective pharmaceutical agents have yet been identified to treat acute kidney injury after cardiac surgery. OBJECTIVE To determine whether fenoldopam reduces the need for renal replacement therapy in critically ill cardiac surgery patients with acute kidney injury. DESIGN, SETTING, AND PARTICIPANTS Multicenter, randomized, double-blind, placebo-controlled, parallel-group stud...
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BACKGROUND Acute kidney injury (AKI) after surgery is associated with increased mortality and healthcare costs. Fenoldopam is a selective dopamine-1 receptor agonist with renoprotective properties. We conducted a systematic review and meta-analysis of randomised controlled trials comparing fenoldopam with placebo to prevent AKI after major surgery. METHODS We searched EMBASE, PubMed, meta-Reg...
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Acute renal failure (ARF) is s a major complication after cardiac surgery and its prevalence still remains high. Even minor changes in serum creatinine are related to an increase morbidity and mortality. Recently two consensus conferences have suggested new diagnostic criteria to define acute kidney injury and risk scores to better identify patients who will probably develop ARF after cardiac s...
متن کاملPeriferic intravenous infusion of fenoldopam through an elastomeric pump
INTRODUCTION Fenoldopam has been used to protect renal function in critically ill patients and in those undergoing major surgery, where a possible damage of kidney is expected. Numerous randomized studies and meta-analysis demonstrated the efficacy of fenoldopam in this setting. We performed this study to demonstrate the feasibility of administering fenoldopam, trough an elastomeric pump connec...
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عنوان ژورنال:
دوره 2 شماره
صفحات -
تاریخ انتشار 2010