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Prophylactic fenoldopam for renal protection in sepsis: A randomized, double-blind, placebo-controlled pilot trial*

Morelli, Andrea MD; Ricci, Zaccaria MD; Bellomo, Rinaldo MD; Ronco, Claudio MD; Rocco, Monica MD; Conti, Giorgio MD; De Gaetano, Andrea MD; Picchini, Umberto; Orecchioni, Alessandra MD; Portieri, Monica MD; Coluzzi, Flaminia MD; Porzi, Patrizia MD; Serio, Paola MD; Bruno, Annunziata MD; Pietropaoli, Paolo MD

doi: 10.1097/01.CCM.0000186413.04875.EF
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Objective: Acute renal failure is common in septic patients. Fenoldopam, a dopamine-1 receptor agonist, increases renal blood flow and may, therefore, reduce the risk of acute renal failure in such patients. Accordingly, we sought to determine the safety and efficacy of fenoldopam for the prevention of acute renal failure in septic patients.

Design: Prospective, double-blind, placebo-controlled trial.

Setting: Three multidisciplinary intensive care units at a university hospital.

Patients: Three hundred septic patients with baseline serum creatinine concentrations <150 μmol/L.

Interventions: We randomized patients to a continuous infusion of either fenoldopam (n = 150) at 0.09 μg·kg−1·min−1 or placebo (n = 150) while in the intensive care unit. The primary outcome measure was the incidence of acute renal failure, defined as a serum creatinine concentration increase to >150 μmol/L, during study drug infusion.

Measurements and main results: The incidence of acute renal failure was significantly lower in the fenoldopam group compared with the control group (29 vs. 51 patients; p = .006). The odds ratio of developing acute renal failure for patients treated with fenoldopam was estimated to be 0.47 (p = .005). The difference in the incidence of severe acute renal failure (creatinine >300 μmol/L), however, failed to achieve statistical significance (10 vs. 21; p = .056). The length of intensive care unit stay in surviving patients was significantly lower in the fenoldopam group compared with the control group (10.64 ± 9.3 vs. 13.4 ± 14.0; p < .001). There were no complications of fenoldopam infusion. A direct effect of treatment on the probability of death, beyond its effect on acute renal failure, was not significant (odds ratio = 0.68, p = .1).

Conclusions: Compared with placebo, low-dose fenoldopam resulted in a smaller increase in serum creatinine in septic patients. The clinical significance of this finding is uncertain. A large multiple-center trial is now needed to confirm these findings.

From the Department of Anesthesiology and Intensive Care (AM, ZR, MR, AO, MP, FC, PP, PS, AB, PP), University of Rome “La Sapienza,” Rome, Italy; Department of Intensive Care and Department of Medicine (RB), Austin Hospital, and University of Melbourne, Heidelberg, Melbourne, Australia; Department of Nephrology, Dialysis and Transplantation (CR), S. Bortolo Hospital, Vicenza, Italy; Department of Anesthesiology and Intensive Care (GC), Catholic University of Rome, Italy; and National Council of Research, Institute of Systems Analysis and Computer Science (ADG, UP), BioMatLab, Rome, Italy.

Supported, in part, by an independent research grant from the Department of Anesthesiology and Intensive Care of the University of Rome “La Sapienza.”

The authors have no financial relationship with a commercial entity that has an interest in the subject of this manuscript.

© 2005 by the Society of Critical Care Medicine and Lippincott Williams & Wilkins