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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 LU ; Orecchioni, Alessandra and Portieri, Monica, et al. (2005) In Critical Care Medicine 33(11). p.2451-2456
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 <150 micromol/L.



INTERVENTIONS:

We randomized patients... (More)
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 micromol/L.



INTERVENTIONS:

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.



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 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. (Less)
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publishing date
type
Contribution to journal
publication status
published
subject
in
Critical Care Medicine
volume
33
issue
11
pages
2451 - 2456
publisher
Lippincott Williams & Wilkins
external identifiers
  • scopus:27944439281
ISSN
1530-0293
DOI
10.1097/01.CCM.0000186413.04875.EF
language
English
LU publication?
no
id
fb71caee-5057-4081-818a-b66d0cd47a4d (old id 4216280)
date added to LUP
2014-01-13 14:06:05
date last changed
2017-10-15 03:23:47
@article{fb71caee-5057-4081-818a-b66d0cd47a4d,
  abstract     = {OBJECTIVE:<br/><br>
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.<br/><br>
<br/><br>
DESIGN:<br/><br>
Prospective, double-blind, placebo-controlled trial.<br/><br>
<br/><br>
SETTING:<br/><br>
Three multidisciplinary intensive care units at a university hospital.<br/><br>
<br/><br>
PATIENTS:<br/><br>
Three hundred septic patients with baseline serum creatinine concentrations &lt;150 micromol/L.<br/><br>
<br/><br>
INTERVENTIONS:<br/><br>
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 &gt;150 micromol/L, during study drug infusion.<br/><br>
<br/><br>
MEASUREMENTS AND MAIN RESULTS:<br/><br>
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 &gt;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 &lt; .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).<br/><br>
<br/><br>
CONCLUSIONS:<br/><br>
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       = {Morelli, Andrea and Ricci, Zaccaria and Bellomo, Rinaldo and Ronco, Claudio and Rocco, Monica and Conti, Giorgio and De Gaetano, Andrea and Picchini, Umberto and Orecchioni, Alessandra and Portieri, Monica and Coluzzi, Flaminia and Porzi, Patrizia and Serio, Paola and Bruno, Annunziata and Pietropaoli, Paolo},
  issn         = {1530-0293},
  language     = {eng},
  number       = {11},
  pages        = {2451--2456},
  publisher    = {Lippincott Williams & Wilkins},
  series       = {Critical Care Medicine},
  title        = {Prophylactic fenoldopam for renal protection in sepsis: a randomized, double blind, placebo-controlled pilot trial},
  url          = {http://dx.doi.org/10.1097/01.CCM.0000186413.04875.EF},
  volume       = {33},
  year         = {2005},
}