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Effect of erythropoietin on the incidence of acute kidney injury following complex valvular heart surgery: a double blind, randomized clinical trial of efficacy and safety

机译:促红细胞生成素对复杂瓣膜心脏手术后急性肾损伤发生率的影响:有效性和安全性的双盲,随机临床试验

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IntroductionRecombinant human erythropoietin (EPO) is known to provide organ protection against ischemia-reperfusion injury through its pleiotropic properties. The aim of this single-site, randomized, case-controlled, and double-blind study was to investigate the effect of pre-emptive EPO administration on the incidence of postoperative acute kidney injury (AKI) in patients with risk factors for AKI undergoing complex valvular heart surgery.MethodsWe studied ninety-eight patients with preoperative risk factors for AKI. The patients were randomly allocated to either the EPO group (n = 49) or the control group (n = 49). The EPO group received 300?IU/kg of EPO intravenously after anesthetic induction. The control group received an equivalent volume of normal saline. AKI was defined as an increase in serum creatinine >0.3?mg/dl or >50% from baseline. Biomarkers of renal injury were serially measured until five days postoperatively.ResultsPatient characteristics and operative data, including the duration of cardiopulmonary bypass, were similar between the two groups. Incidence of postoperative AKI (32.7% versus 34.7%, P?=?0.831) and biomarkers of renal injury including cystatin C and neutrophil gelatinase-associated lipocalin showed no significant differences between the groups. The postoperative increase in interleukin-6 and myeloperoxidase was similar between the groups. None of the patients developed adverse complications related to EPO administration, including thromboembolic events, throughout the study period.ConclusionsIntravenous administration of 300?IU/kg of EPO did not provide renal protection in patients who are at increased risk of developing AKI after undergoing complex valvular heart surgery.Trial registrationClinical Trial.gov, NCT01758861
机译:简介重组人促红细胞生成素(EPO)通过其多效性可为器官提供抗缺血再灌注损伤的保护。这项单点,随机,病例对照和双盲研究的目的是研究先发性EPO给药对患有复杂性AKI危险因素的患者术后急性肾损伤(AKI)发生率的影响方法我们研究了98例具有AKI术前危险因素的患者。将患者随机分为EPO组(n = 49)或对照组(n = 49)。麻醉诱导后,EPO组静脉注射300?IU / kg EPO。对照组接受等量的生理盐水。 AKI被定义为血清肌酐比基线增加> 0.3?mg / dl或> 50%。连续测量肾损伤的生物标志物,直到术后5天。结果两组的患者特征和手术数据(包括体外循环持续时间)相似。术后AKI的发生率(32.7%对34.7%,P <= 0.831)和包括半胱氨酸蛋白酶抑制剂C和中性粒细胞明胶酶相关的脂钙素在内的肾损伤的生物标志物在两组之间无显着差异。两组之间术后白细胞介素6和髓过氧化物酶升高相似。在整个研究期间,没有患者发生与EPO给药相关的不良并发症,包括血栓栓塞事件。结论静脉输注300?IU / kg的EPO不能为患有复杂瓣膜后发展AKI风险的患者提供肾脏保护心脏外科手术。临床注册临床Trial.gov,NCT01758861

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