title: Prophylactic fenoldopam for renal protection in sepsis: a randomized, double-blind, placebo-controlled pilot trial.
abstract: 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.
  
  
  METHODS
  Prospective, double-blind, placebo-controlled trial.
  
  
  METHODS
  Three multidisciplinary intensive care units at a university hospital.
  
  
  METHODS
  Three hundred septic patients with baseline serum creatinine concentrations <150 micromol/L.
  
  
  METHODS
  We randomized patients to a continuous infusion of either fenoldopam (n = 150) at 0.09 microg x kg x min 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 micromol/L, during study drug infusion.
  
  
  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 mumol/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.
authors.affiliation: Department of Anesthesiology and Intensive Care, University of Rome La Sapienza, Rome, Italy.
authors.forename: Andrea
authors.initials: A
authors.lastname: Morelli
authors.forename: Zaccaria
authors.initials: Z
authors.lastname: Ricci
authors.forename: Rinaldo
authors.initials: R
authors.lastname: Bellomo
authors.forename: Claudio
authors.initials: C
authors.lastname: Ronco
authors.forename: Monica
authors.initials: M
authors.lastname: Rocco
authors.forename: Giorgio
authors.initials: G
authors.lastname: Conti
authors.forename: Andrea
authors.initials: A
authors.lastname: De Gaetano
authors.forename: Umberto
authors.initials: U
authors.lastname: Picchini
authors.forename: Alessandra
authors.initials: A
authors.lastname: Orecchioni
authors.forename: Monica
authors.initials: M
authors.lastname: Portieri
authors.forename: Flaminia
authors.initials: F
authors.lastname: Coluzzi
authors.forename: Patrizia
authors.initials: P
authors.lastname: Porzi
authors.forename: Paola
authors.initials: P
authors.lastname: Serio
authors.forename: Annunziata
authors.initials: A
authors.lastname: Bruno
authors.forename: Paolo
authors.initials: P
authors.lastname: Pietropaoli
mesh_terms: D058186:Acute Kidney Injury / Q000209:etiology / Q000517:prevention & control*; D003404:Creatinine / Q000097:blood; D018491:Dopamine Agonists / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D018818:Fenoldopam / Q000627:therapeutic use*; D006801:Humans; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D018805:Sepsis / Q000150:complications
chemical_list: D018491:Dopamine Agonists; D003404:Creatinine; D018818:Fenoldopam