Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK.
Department of Cardiovascular Sciences and National Institute for Health Research Leicester Biomedical Research Unit in Cardiovascular Medicine, University of Leicester, Clinical Sciences Wing, Glenfield General Hospital, Leicester, UK; University of Nottingham, Royal Derby Hospital, Derby, UK.
Br J Anaesth. 2020 Jun;124(6):693-701. doi: 10.1016/j.bja.2020.01.030. Epub 2020 Apr 1.
This study assessed whether i.v. sildenafil citrate prevented acute kidney injury in at-risk patients undergoing cardiac surgery with cardiopulmonary bypass.
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 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.
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 [-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.
These results do not support the use of i.v. sildenafil citrate for kidney protection in adult cardiac surgery.
ISRCTN18386427.
本研究评估了静脉注射枸橼酸西地那非是否可预防体外循环心脏手术高危患者的急性肾损伤。
在一项双盲 RCT 中，在英国一家三级中心接受心脏手术的、具有急性肾损伤风险的成年患者被随机分配接受静脉注射 12.5mg/kg 西地那非枸橼酸盐 150 分钟或手术开始时给予 5%葡萄糖。主要结局是在随机分组后六个时间点测量血清肌酐。主要分析采用线性混合效应模型进行调整，包括分层变量、基线估计肾小球滤过率和手术程序。次要结局考虑了临床事件和潜在的疾病机制。效应估计值表示为均数差值（MD）或比值比及其 95%置信区间。
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联合冠状动脉旁路移植和瓣膜手术的有资格接受随机分组的患者，且使用体外循环。西地那非组有 60 名患者，安慰剂对照组有 69 名患者。两组间肌酐浓度差异无统计学意义（MD：0.88 μmol/L [-5.82, 7.59]）。西地那非组的多器官功能障碍评分有统计学显著升高（MD：0.54 [0.02, 1.07]；P=0.044）。两组间的次要结局以及肾损伤、内皮功能和炎症细胞激活的生物标志物均无显著差异。
这些结果不支持在成人心脏手术中使用静脉注射西地那非枸橼酸盐来保护肾脏。
ISRCTN85126427。
