Effect of Fenoldopam on Use of Renal Replacement Therapy Among Patients With Acute Kidney Injury After Cardiac Surgery A Randomized Clinical Trial
Effect of Fenoldopam on Use of Renal Replacement Therapy Among Patients With Acute Kidney Injury After Cardiac Surgery A Randomized Clinical Trial
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DOI：
10.1001/jama.2014.13573
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发表时间：
2014-12-03
影响因子：
120.7
通讯作者：
Landoni, Giovanni
中科院分区：
文献类型：
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作者：
Bove, Tiziana;Zangrillo, Alberto;Landoni, Giovanni
重要性尚未确定治疗心脏手术后急性肾损伤的有效药物。目的：确定非诺多泮是否可减少心脏手术后急性肾损伤危重患者对肾脏替代治疗的需求。2008年3月至2013年4月在意大利19个心血管重症监护病房进行的平行组研究。我们将667例心脏手术后入住重症监护室的早期急性肾损伤患者（血清肌酐水平较基线升高>= 50%或少尿>= 6小时）随机分配接受非诺多泮（338例患者）或安慰剂（329例患者）。我们使用计算机生成的排列区组随机化序列进行治疗分配。所有患者在手术后30天完成随访，并根据意向治疗原则对数据进行分析。干预连续输注非诺多泮或安慰剂长达4天，起始剂量为0.1 μ g/kg/min（范围，0.025-0.3 μ g/kg/min）。次要终点包括死亡率（重症监护室和30天死亡率）和研究药物输注过程中的低血压率。69/338例患者（20%）分配到非诺多泮组，60/329例患者（18%）分配到安慰剂组接受肾脏替代治疗（P = 0.47）。非诺多泮组338例患者中有78例（23%）在30天时死亡，安慰剂组329例患者中有74例（22%）在30天时死亡（P = .86）。非诺多泮组85例（26%）患者发生低血压，安慰剂组49例（15%）患者发生低血压（P = .001）。结论和相关性在心脏手术后急性肾损伤患者中，与安慰剂相比，非诺多泮输注并没有减少肾脏替代治疗的需要或30天死亡率的风险，但与低血压的发生率增加有关。
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 mu g/kg/min (range, 0.025-0.3 mu g/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.