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Intravenous sildenafil citrate and post-cardiac surgery acute kidney injury: a double-blind, randomised, placebo-controlled trial.
British Journal of Anaesthesia ( IF 9.8 ) Pub Date : 2020-04-01 , DOI: 10.1016/j.bja.2020.01.030
Tracy Kumar 1 , Hardeep Aujla 1 , Marcin Woźniak 1 , Will Dott 1 , Nikol Sullo 2 , Lathishia Joel-David 1 , Paolo Pais 1 , Dawn Smallwood 3 , Douglas Miller 1 , Bryony Eagle-Hemming 1 , Ana Suazo Di Paola 4 , Shaun Barber 4 , Cassandra Brookes 4 , Nigel J Brunskill 5 , Gavin J Murphy 6
Affiliation  

BACKGROUND This study assessed whether i.v. sildenafil citrate prevented acute kidney injury in at-risk patients undergoing cardiac surgery with cardiopulmonary bypass. METHODS In a double-blind RCT, adults at increased risk of acute kidney injury undergoing cardiac surgery in a single UK tertiary centre were randomised to receive sildenafil citrate 12.5 mg kg-1 i.v. over 150 min or dextrose 5% at the commencement of surgery. The primary outcome was serum creatinine measured at six post-randomisation time points. The primary analysis used a linear mixed-effects model adjusted for the stratification variables, baseline estimated glomerular filtration rate, and surgical procedure. Secondary outcomes considered clinical events and potential disease mechanisms. Effect estimates were expressed as mean differences (MDs) or odds ratios with 95% confidence intervals. RESULTS The analysis population comprised eligible randomised patients that underwent valve surgery or combined coronary artery bypass graft and valve surgery, with cardiopulmonary bypass, between May 2015 and June 2018. There were 60 subjects in the sildenafil group and 69 in the placebo control group. The difference between groups in creatinine concentration was not statistically significant (MD: 0.88 μmol L-1 [-5.82, 7.59]). There was a statistically significant increase in multiple organ dysfunction scores in the sildenafil group (MD: 0.54 [0.02, 1.07]; P=0.044). Secondary outcomes, and biomarkers of kidney injury, endothelial function, and inflammatory cell activation, were not significantly different between the groups. CONCLUSIONS These results do not support the use of i.v. sildenafil citrate for kidney protection in adult cardiac surgery. CLINICAL TRIAL REGISTRATION ISRCTN18386427.

中文翻译:

静脉注射枸橼酸西地那非和心脏手术后急性肾损伤:一项双盲、随机、安慰剂对照试验。

背景 本研究评估了枸橼酸西地那非静脉注射能否预防接受体外循环心脏手术的高危患者的急性肾损伤。方法 在一项双盲 RCT 中,在英国一家三级中心接受心脏手术的急性肾损伤风险增加的成年人随机接受 150 分钟内 iv 枸橼酸西地那非 12.5 mg kg-1 或在手术开始时接受 5% 葡萄糖。主要结果是在随机化后的六个时间点测量的血清肌酐。主要分析使用针对分层变量、基线估计肾小球滤过率和手术程序调整的线性混合效应模型。次要结果考虑了临床事件和潜在的疾病机制。效果估计值表示为平均差异 (MD) 或具有 95% 置信区间的优势比。结果 分析人群包括在 2015 年 5 月至 2018 年 6 月期间接受瓣膜手术或冠状动脉旁路移植术和瓣膜手术联合体外循环的合格随机患者。西地那非组有 60 名受试者,安慰剂对照组有 69 名受试者。肌酐浓度组间差异无统计学意义(MD:0.88 μmol L-1 [-5.82, 7.59])。西地那非组的多器官功能障碍评分有统计学显着增加(MD:0.54 [0.02, 1.07];P=0.044)。次要结果以及肾损伤、内皮功能和炎症细胞活化的生物标志物在各组之间没有显着差异。结论 这些结果不支持在成人心脏手术中使用 iv 枸橼酸西地那非保护肾脏。临床试验注册 ISRCTN18386427。
更新日期:2020-04-01
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