title: Effect of fenoldopam on use of renal replacement therapy among patients with acute kidney injury after cardiac surgery: a randomized clinical trial.
abstract: OBJECTIVE
  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.
  
  
  METHODS
  Multicenter, randomized, double-blind, placebo-controlled, parallel-group study from March 2008 to April 2013 in 19 cardiovascular intensive care units in Italy. We randomly assigned 667 patients admitted to intensive care units after cardiac surgery with early acute kidney injury (≥50% increase of serum creatinine level from baseline or oliguria for ≥6 hours) to receive fenoldopam (338 patients) or placebo (329 patients). We used a computer-generated permuted block randomization sequence for treatment allocation. All patients completed their follow-up 30 days after surgery, and data were analyzed according to the intention-to-treat principle.
  
  
  METHODS
  Continuous infusion of fenoldopam or placebo for up to 4 days with a starting dose of 0.1 μg/kg/min (range, 0.025-0.3 µg/kg/min).
  
  
  METHODS
  The primary end point was the rate of renal replacement therapy. Secondary end points included mortality (intensive care unit and 30-day mortality) and the rate of hypotension during study drug infusion.
  
  
  RESULTS
  The study was stopped for futility as recommended by the safety committee after a planned interim analysis. Sixty-nine of 338 patients (20%) allocated to the fenoldopam group and 60 of 329 patients (18%) allocated to the placebo group received renal replacement therapy (P = .47). Mortality at 30 days was 78 of 338 (23%) in the fenoldopam group and 74 of 329 (22%) in the placebo group (P = .86). Hypotension occurred in 85 (26%) patients in the fenoldopam group and in 49 (15%) patients in the placebo group (P = .001).
  
  
  CONCLUSIONS
  Among patients with acute kidney injury after cardiac surgery, fenoldopam infusion, compared with placebo, did not reduce the need for renal replacement therapy or risk of 30-day mortality but was associated with an increased rate of hypotension.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT00621790.
authors.affiliation: IRCCS San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Tiziana
authors.initials: T
authors.lastname: Bove
authors.affiliation: IRCCS San Raffaele Scientific Institute, Milan, Italy19Vita-Salute San Raffaele University, Milan, Italy.
authors.forename: Alberto
authors.initials: A
authors.lastname: Zangrillo
authors.affiliation: University Hospital of Pisa, Pisa, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Guarracino
authors.affiliation: Mater Domini Hospital, Catanzaro, Italy.
authors.forename: Gabriele
authors.initials: G
authors.lastname: Alvaro
authors.affiliation: Ospedale Civile "Ca' Foncello" di Treviso, Treviso, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Persi
authors.affiliation: Siena Hospital, Siena, Italy.
authors.forename: Enivarco
authors.initials: E
authors.lastname: Maglioni
authors.affiliation: A. O. R. N. "Dei Colli," Monaldi Hospital, Napoli, Italy.
authors.forename: Nicola
authors.initials: N
authors.lastname: Galdieri
authors.affiliation: Mauriziano Hospital, Turin, Italy.
authors.forename: Marco
authors.initials: M
authors.lastname: Comis
authors.affiliation: S. Orsola-Malpighi University Hospital, Bologna, Italy.
authors.forename: Fabio
authors.initials: F
authors.lastname: Caramelli
authors.affiliation: Città della Salute e della Scienza Hospital, University of Turin, Turin, Italy.
authors.forename: Daniela C
authors.initials: DC
authors.lastname: Pasero
authors.affiliation: Ospedale Civile "SS Annunziata," Sassari, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Pala
authors.affiliation: Ospedale Santa Maria della Misericordia, Perugia, Italy.
authors.forename: Massimo
authors.initials: M
authors.lastname: Renzini
authors.affiliation: Maria Cecilia Hospital-GVM Care and Research, Cotignola and Città di Lecce Hospital, Lecce, Italy.
authors.forename: Massimiliano
authors.initials: M
authors.lastname: Conte
authors.affiliation: A. O. Regionale "San Carlo," Potenza, Italy.
authors.forename: Gianluca
authors.initials: G
authors.lastname: Paternoster
authors.affiliation: Santa Maria della Misericordia University Hospital of Udine, Udine, Italy.
authors.forename: Blanca
authors.initials: B
authors.lastname: Martinez
authors.affiliation: Careggi University Hospital, Florence, Italy.
authors.forename: Fulvio
authors.initials: F
authors.lastname: Pinelli
authors.affiliation: A. O. Spedali Civili di Brescia, Brescia, Italy.
authors.forename: Mario
authors.initials: M
authors.lastname: Frontini
authors.affiliation: A. O. Ospedali Riuniti Papardo-Piemonte, Messina, Italy.
authors.forename: Maria C
authors.initials: MC
authors.lastname: Zucchetti
authors.affiliation: IRCCS San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Federico
authors.initials: F
authors.lastname: Pappalardo
authors.affiliation: Mater Domini Hospital, Catanzaro, Italy.
authors.forename: Bruno
authors.initials: B
authors.lastname: Amantea
authors.affiliation: Ospedale Civile "Ca' Foncello" di Treviso, Treviso, Italy.
authors.forename: Annamaria
authors.initials: A
authors.lastname: Camata
authors.affiliation: A. O. R. N. "Dei Colli," Monaldi Hospital, Napoli, Italy.
authors.forename: Antonio
authors.initials: A
authors.lastname: Pisano
authors.affiliation: Mauriziano Hospital, Turin, Italy.
authors.forename: Claudio
authors.initials: C
authors.lastname: Verdecchia
authors.affiliation: S. Orsola-Malpighi University Hospital, Bologna, Italy.
authors.forename: Erika
authors.initials: E
authors.lastname: Dal Checco
authors.affiliation: University Hospital of Pisa, Pisa, Italy.
authors.forename: Claudia
authors.initials: C
authors.lastname: Cariello
authors.affiliation: Mater Domini Hospital, Catanzaro, Italy.
authors.forename: Luana
authors.initials: L
authors.lastname: Faita
authors.affiliation: University Hospital of Pisa, Pisa, Italy.
authors.forename: Rubia
authors.initials: R
authors.lastname: Baldassarri
authors.affiliation: IRCCS San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Anna M
authors.initials: AM
authors.lastname: Scandroglio
authors.affiliation: IRCCS San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Omar
authors.initials: O
authors.lastname: Saleh
authors.affiliation: IRCCS San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Rosalba
authors.initials: R
authors.lastname: Lembo
authors.affiliation: IRCCS San Raffaele Scientific Institute, Milan, Italy.
authors.forename: Maria G
authors.initials: MG
authors.lastname: Calabrò
authors.affiliation: Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, Melbourne, Australia.
authors.forename: Rinaldo
authors.initials: R
authors.lastname: Bellomo
authors.affiliation: IRCCS San Raffaele Scientific Institute, Milan, Italy19Vita-Salute San Raffaele University, Milan, Italy.
authors.forename: Giovanni
authors.initials: G
authors.lastname: Landoni
mesh_terms: D058186:Acute Kidney Injury; D000368:Aged; D006348:Cardiac Surgical Procedures; D003404:Creatinine; D016638:Critical Illness; D004311:Double-Blind Method; D005260:Female; D018818:Fenoldopam / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D007022:Hypotension / Q000139:chemically induced; D007362:Intensive Care Units; D008297:Male; D008875:Middle Aged; D011183:Postoperative Complications; D017582:Renal Replacement Therapy / Q000379:methods*; D014481:United States; D014665:Vasodilator Agents / Q000009:adverse effects / Q000627:therapeutic use*
chemical_list: D014665:Vasodilator Agents; D003404:Creatinine; D018818:Fenoldopam