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


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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    • "Data on new requirement for RRT in the post-operative period were available in five of the six RCTs (total of 478 patients)1516171819. Of 241 patients in the fenoldopam group, 2 (0.8 %) were treated with RRT post-operatively compared to 12 (4.5 %) of the 237 patients treated with placebo. "
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    ABSTRACT: Background: Acute kidney injury (AKI) after surgery is associated with increased mortality and healthcare costs. Fenoldopam is a selective dopamine-1 receptor agonist with renoprotective properties. We conducted a systematic review and meta-analysis of randomised controlled trials comparing fenoldopam with placebo to prevent AKI after major surgery. Methods: We searched EMBASE, PubMed, meta-Register of randomised controlled trials and Cochrane CENTRAL databases for trials comparing fenoldopam with placebo in patients undergoing major surgery. The primary outcome was incidence of new AKI. Secondary outcomes were requirement for renal replacement therapy and hospital mortality. Results: Eighty-three publications were screened; 23 studies underwent full data extraction and scoring. Six trials were suitable for inclusion in the data synthesis (total of 507 subjects undergoing cardiovascular surgery, partial nephrectomy, liver transplant surgery). Five studies were rated at high risk of bias. Data on post-operative incidence of AKI were available in five of the six trials (total of 471 patients) but definitions of AKI varied between studies. Of the 238 patients receiving fenoldopam, 45 (18.9 %) developed AKI compared to 62 (26.6 %) of the 233 patients who received placebo (p = 0.004, I (2) = 0 %; random-effects model odds ratio 0.46, 95 % confidence interval 0.27-0.79). In patients treated with fenoldopam, there was no difference in renal replacement therapy (n = 478; p = 0.11, I (2) = 47 %; fixed-effect model odds ratio 0.27, 95 % confidence interval 0.06-1.19) or hospital mortality (p = 0.60, I (2) = 0 %; fixed-effect model odds ratio 1.0, 95 % confidence interval 0.14-7.37). Conclusions: In this analysis, peri-operative treatment with fenoldopam was associated with a significant reduction in post-operative AKI but it had no impact on renal replacement therapy or hospital mortality. Equipoise remains for further large trials in this area since the studies were conducted in three types of surgery, the majority of studies were rated at high risk of bias and the criteria for AKI varied between trials.
    Full-text · Article · Dec 2015 · Critical Care
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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.
    Full-text · Article · Apr 2014 · Revista Brasileira de Terapia Intensiva
    • "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.
    No preview · Article · Jul 2012 · Indian Journal of Urology
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