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JAMA. 2014 Dec 3;312(21):2244-53. doi: 10.1001/jama.2014.13573.

Effect of fenoldopam on use of renal replacement therapy among patients with acute kidney injury after cardiac surgery: a randomized clinical trial.

Author information

1
IRCCS San Raffaele Scientific Institute, Milan, Italy.
2
IRCCS San Raffaele Scientific Institute, Milan, Italy19Vita-Salute San Raffaele University, Milan, Italy.
3
University Hospital of Pisa, Pisa, Italy.
4
Mater Domini Hospital, Catanzaro, Italy.
5
Ospedale Civile "Ca' Foncello" di Treviso, Treviso, Italy.
6
Siena Hospital, Siena, Italy.
7
A. O. R. N. "Dei Colli," Monaldi Hospital, Napoli, Italy.
8
Mauriziano Hospital, Turin, Italy.
9
S. Orsola-Malpighi University Hospital, Bologna, Italy.
10
Città della Salute e della Scienza Hospital, University of Turin, Turin, Italy.
11
Ospedale Civile "SS Annunziata," Sassari, Italy.
12
Ospedale Santa Maria della Misericordia, Perugia, Italy.
13
Maria Cecilia Hospital-GVM Care and Research, Cotignola and Città di Lecce Hospital, Lecce, Italy.
14
A. O. Regionale "San Carlo," Potenza, Italy.
15
Santa Maria della Misericordia University Hospital of Udine, Udine, Italy.
16
Careggi University Hospital, Florence, Italy.
17
A. O. Spedali Civili di Brescia, Brescia, Italy.
18
A. O. Ospedali Riuniti Papardo-Piemonte, Messina, Italy.
19
Australian and New Zealand Intensive Care Research Centre, Monash University School of Public Health and Preventive Medicine, Melbourne, Australia.

Abstract

IMPORTANCE:

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.

DESIGN, SETTING, AND PARTICIPANTS:

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.

INTERVENTIONS:

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).

MAIN OUTCOMES AND MEASURES:

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 AND RELEVANCE:

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.

TRIAL REGISTRATION:

clinicaltrials.gov Identifier: NCT00621790.

PMID:
25265449
DOI:
10.1001/jama.2014.13573
[Indexed for MEDLINE]

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