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HSR Proc Intensive Care Cardiovasc Anesth. 2010;2(2):111-7.

Fenoldopam to prevent renal replacement therapy after cardiac surgery. Design of the FENO-HSR study.

HSR proceedings in intensive care & cardiovascular anesthesia

G Landoni, T Bove, D Pasero, M Comis, S Orando, F Pinelli, F Guarracino, A Corcione, N Galdieri, M Zucchetti, E Maglioni, B Biagioli, G Pala, M Frontini, F Caramelli, B Persi, M Renzini, F Paoletti, L Lorini, A Morelli, G Alvaro, R Bianco, D Pittarello, A Manzato, G Pedersini, A Mizzi, N Lojacono, P Leoncini, T Iovino, C Cariello, R Baldassarri, A M Camata, G Padua, G Frascaroli, S Leonardi, E Bignami, A Zangrillo

Affiliations

  1. Università Vita-Salute San Raffaele, Milano.

PMID: 23440680 PMCID: PMC3484615

Abstract

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.

Keywords: acute renal failure; anesthesia; cardiac surgery; cardiac surgical procedures; fenoldopam; renal replacement therapy

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