Prophylactic fenoldopam for renal protection in sepsis

A randomized, double-blind, placebo-controlled pilot trial

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

Research output: Contribution to journalArticle

92 Citations (Scopus)

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. 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 -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.

Original languageEnglish
Pages (from-to)2451-2456
Number of pages6
JournalCritical Care Medicine
Volume33
Issue number11
DOIs
Publication statusPublished - Nov 2005

Fingerprint

Fenoldopam
Acute Kidney Injury
Sepsis
Placebos
Kidney
Creatinine
Intensive Care Units
Incidence
Serum
Odds Ratio
Control Groups
Renal Circulation
Dopamine Agonists
Outcome Assessment (Health Care)

ASJC Scopus subject areas

  • Critical Care and Intensive Care Medicine

Cite this

Prophylactic fenoldopam for renal protection in sepsis : A randomized, double-blind, placebo-controlled pilot trial. / Morelli, Andrea; Ricci, Zaccaria; Bellomo, Rinaldo; Ronco, Claudio; Rocco, Monica; Conti, Giorgio; De Gaetano, Andrea; Picchini, Umberto; Orecchioni, Alessandra; Portieri, Monica; Coluzzi, Flaminia; Porzi, Patrizia; Serio, Paola; Bruno, Annunziata; Pietropaoli, Paolo.

In: Critical Care Medicine, Vol. 33, No. 11, 11.2005, p. 2451-2456.

Research output: Contribution to journalArticle

Morelli, A, Ricci, Z, Bellomo, R, Ronco, C, Rocco, M, Conti, G, De Gaetano, A, Picchini, U, Orecchioni, A, Portieri, M, Coluzzi, F, Porzi, P, Serio, P, Bruno, A & Pietropaoli, P 2005, 'Prophylactic fenoldopam for renal protection in sepsis: A randomized, double-blind, placebo-controlled pilot trial', Critical Care Medicine, vol. 33, no. 11, pp. 2451-2456. https://doi.org/10.1097/01.CCM.0000186413.04875.EF
Morelli, Andrea ; Ricci, Zaccaria ; Bellomo, Rinaldo ; Ronco, Claudio ; Rocco, Monica ; Conti, Giorgio ; De Gaetano, Andrea ; Picchini, Umberto ; Orecchioni, Alessandra ; Portieri, Monica ; Coluzzi, Flaminia ; Porzi, Patrizia ; Serio, Paola ; Bruno, Annunziata ; Pietropaoli, Paolo. / Prophylactic fenoldopam for renal protection in sepsis : A randomized, double-blind, placebo-controlled pilot trial. In: Critical Care Medicine. 2005 ; Vol. 33, No. 11. pp. 2451-2456.
@article{97c6765b2ed04998910c95a43859fb02,
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. 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 -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.",
author = "Andrea Morelli and Zaccaria Ricci and Rinaldo Bellomo and Claudio Ronco and Monica Rocco and Giorgio Conti and {De Gaetano}, Andrea and Umberto Picchini and Alessandra Orecchioni and Monica Portieri and Flaminia Coluzzi and Patrizia Porzi and Paola Serio and Annunziata Bruno and Paolo Pietropaoli",
year = "2005",
month = "11",
doi = "10.1097/01.CCM.0000186413.04875.EF",
language = "English",
volume = "33",
pages = "2451--2456",
journal = "Critical Care Medicine",
issn = "0090-3493",
publisher = "Lippincott Williams and Wilkins",
number = "11",

}

TY - JOUR

T1 - Prophylactic fenoldopam for renal protection in sepsis

T2 - A randomized, double-blind, placebo-controlled pilot trial

AU - Morelli, Andrea

AU - Ricci, Zaccaria

AU - Bellomo, Rinaldo

AU - Ronco, Claudio

AU - Rocco, Monica

AU - Conti, Giorgio

AU - De Gaetano, Andrea

AU - Picchini, Umberto

AU - Orecchioni, Alessandra

AU - Portieri, Monica

AU - Coluzzi, Flaminia

AU - Porzi, Patrizia

AU - Serio, Paola

AU - Bruno, Annunziata

AU - Pietropaoli, Paolo

PY - 2005/11

Y1 - 2005/11

N2 - 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 -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.

AB - 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 -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.

UR - http://www.scopus.com/inward/record.url?scp=27944439281&partnerID=8YFLogxK

UR - http://www.scopus.com/inward/citedby.url?scp=27944439281&partnerID=8YFLogxK

U2 - 10.1097/01.CCM.0000186413.04875.EF

DO - 10.1097/01.CCM.0000186413.04875.EF

M3 - Article

VL - 33

SP - 2451

EP - 2456

JO - Critical Care Medicine

JF - Critical Care Medicine

SN - 0090-3493

IS - 11

ER -