Fenoldopam Infusion for Renal Protection in High-Risk Cardiac Surgery Patients: A Randomized Clinical Study

Department of Anesthesia and Intensive Care, Villa Maria Cecilia Hospital, Cotignola, Ravenna, Italy.
Journal of Cardiothoracic and Vascular Anesthesia (Impact Factor: 1.46). 01/2008; 21(6):847-50. DOI: 10.1053/j.jvca.2007.02.022
Source: PubMed

ABSTRACT The purpose of this study was to evaluate the renoprotective effects of fenoldopam in patients at high risk of postoperative acute kidney injury undergoing elective cardiac surgery requiring cardiopulmonary bypass.
A double-blind randomized clinical trial. Setting: Hospital. Participants: One hundred ninety-three patients. Interventions: Patients undergoing cardiac surgery were randomly assigned to receive a continuous infusion of fenoldopam, 0.1 microg/kg/min (95 patients), or placebo (98 patients) for 24 hours. Patients were included if at least 1 of the following risk factors was present: preoperative serum creatinine > or =1.5 mg/dL, age >70 years, diabetes mellitus, or prior cardiac surgery. Serum creatinine and urinary output were measured at baseline (T1), 24 hours (T2), and 48 hours after surgery (T3). Acute kidney injury was defined as a postoperative serum creatinine level of > or =2 mg/dL with an increase in serum creatinine level of 0.7 mg/dL or greater from preoperative to maximum postoperative values.
Acute kidney injury developed in 12 of 95 (12.6%) patients receiving fenoldopam and in 27 of 98 (27.6%) patients receiving placebo (p = 0.02), whereas renal replacement therapy was started in 0 of 95 and 8 of 98 (8.2%) patients, respectively (p = 0.004). Serum creatinine was similar at baseline (1.8 +/- 0.4 mg/dL v 1.9 +/- 0.3 mg/dL) in the fenoldopam and placebo groups but differed significantly (p < 0.001 and p < 0.001) 24 hours (1.6 +/- 0.2 mg/dL v 2.5 +/- 0.6 mg/dL) and 48 hours (1.5 +/- 0.3 mg/dL v 2.8 +/- 0.4 mg/dL) after the operation.
A 24-hour infusion of 0.1 mug/kg/min of fenoldopam prevented acute kidney injury in a high-risk population undergoing cardiac surgery.

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    • "In the majority of the studies (n=9), the only surgical procedure evaluated was coronary artery bypass grafting.(14,16,19-24,29) For the other studies (n=7), the surgical procedures evaluated were combined surgeries, in which replacement or repair of the valve was performed in association with coronary artery bypass grafting.(15,17,18,25-28) "
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    ABSTRACT: Acute kidney injury is a common complication after cardiac surgery and is associated with increased morbidity and mortality and increased length of stay in the intensive care unit. Considering the high prevalence of acute kidney injury and its association with worsened prognosis, the development of strategies for renal protection in hospitals is essential to reduce the associated high morbidity and mortality, especially for patients at high risk of developing acute kidney injury, such as patients who undergo cardiac surgery. This integrative review sought to assess the evidence available in the literature regarding the most effective interventions for the prevention of acute kidney injury in patients undergoing cardiac surgery. To select the articles, we used the CINAHL and MedLine databases. The sample of this review consisted of 16 articles. After analyzing the articles included in the review, the results of the studies showed that only hydration with saline has noteworthy results in the prevention of acute kidney injury. The other strategies are controversial and require further research to prove their effectiveness.
    Revista Brasileira de Terapia Intensiva 04/2014; 26(2):183-192. DOI:10.5935/0103-507X.20140027
    • "dose is 0.03–0.1 ugm/kg/h[38] "
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    ABSTRACT: Postoperative acute renal failure (ARF) is a serious complication which can result in a prolonged hospital stay and a high mortality and morbidity. Underlying renal disease, cardiac diseases, nephrotoxin exposure and renal hypoperfusion are the possible predisposing risk factors which can create a high probability for the development of ARF. The incidence of ARF is highest after major vascular, cardiac and high-risk thoraco-abdominal surgery. Among the various renal protection strategies, adequate peri-operative volume expansion and avoidance of hypovolemia is the most accepted and practiced strategy. Numerous bio-markers of renal injury are used to estimate the presence and extent of renal insult and various new are currently under trial. Traditional pharmacological interventions like dopamine, diuretics and calcium antagonists are not currently the first line of reno-protective agents. The new non-pharmacological and pharmacological methods may improve outcome in renal transplantation, contrast-induced nephropathy and in various other settings of ARF. The current review is an attempt to refresh the knowledge and put forth the various renal protection strategies during the peri-operative period.
    Indian Journal of Urology 07/2012; 28(3):248-55. DOI:10.4103/0970-1591.102691
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    • "Several studies suggested that fenoldopam could have a nephroprotective action in a cardiac surgery setting, even when it is used before surgery [9,10,11,12], but they were not powered enough to detect an improvement in clinical relevant outcomes, such as the need for renal replacement therapy or mortality. "
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    ABSTRACT: Acute kidney injury requiring renal replacement therapy is a serious complication following cardiac surgery associated with poor clinical outcomes. Until now no drug showed nephroprotective effects. Fenoldopam is a dopamine-1 receptor agonist which seems to be effective in improving postoperative renal function. The aim of this paper is to describe the design of the FENO-HSR study, planned to assess the effect of a continuous infusion of fenoldopam in reducing the need for renal replacement therapy in patients with acute kidney injury after cardiac surgery. We're performing a double blind, placebo-controlled multicentre randomized trial in over 20 Italian hospitals. Patients who develop acute renal failure defined as R of RIFLE score following cardiac surgery are randomized to receive a 96-hours continuous infusion of either fenoldopam (0.025-0.3 µg/kg/min) or placebo. The primary endpoint will be the rate of renal replacement therapy. Secondary endpoints will be: mortality, time on mechanical ventilation, length of intensive care unit and hospital stay, peak serum creatinine and the rate of acute renal failure (following the RIFLE score). This trial is planned to assess if fenoldopam could improve relevant outcomes in patients undergoing cardiac surgery who develop acute renal dysfunction. Results of this double-blind randomized trial could provide important insights to improve the management strategy of patients at high risk for postoperative acute kidney injury.
    03/2010; 2(2):111-7.
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