Laboratory of Interventional Cardiology, Department of Cardiology, Clinica Mediterranea, Naples, Italy.
Circulation. 2011 Sep 13;124(11):1260-9. doi: 10.1161/CIRCULATIONAHA.111.030759. Epub 2011 Aug 15.
The RenalGuard System, which creates high urine output and fluid balancing, may be beneficial in preventing contrast-induced acute kidney injury.
The Renal Insufficiency After Contrast Media Administration Trial II (REMEDIAL II) trial is a randomized, multicenter, investigator-driven trial addressing the prevention of contrast-induced acute kidney injury in high-risk patients. Patients with an estimated glomerular filtration rate ≤30 mL · min(-1) · 1.73 m(-2) and/or a risk score ≥11 were randomly assigned to sodium bicarbonate solution and N-acetylcysteine (control group) or hydration with saline and N-acetylcysteine controlled by the RenalGuard System and furosemide (RenalGuard group). The primary end point was an increase of ≥0.3 mg/dL in the serum creatinine concentration at 48 hours after the procedure. The secondary end points included serum cystatin C kinetics and rate of in-hospital dialysis. Contrast-induced acute kidney injury occurred in 16 of 146 patients in the RenalGuard group (11%) and in 30 of 146 patients in the control group (20.5%; odds ratio, 0.47; 95% confidence interval, 0.24 to 0.92). There were 142 patients (48.5%) with an estimated glomerular filtration rate ≤30 mL · min(-1) · 1.73 and 149 patients (51.5%) with only a risk score ≥11. Subgroup analysis according to inclusion criteria showed a similarly lower risk of adverse events (estimated glomerular filtration rate ≤30 mL · min(-1) · 1.73 m(-2): odds ratio, 0.44; risk score ≥11: odds ratio, 0.45; P for interaction=0.97). Changes in cystatin C at 24 hours (0.02±0.32 versus -0.08±0.26; P=0.002) and 48 hours (0.12±0.42 versus 0.03±0.31; P=0.001) and the rate of in-hospital dialysis (4.1% versus 0.7%; P=0.056) were higher in the control group.
RenalGuard therapy is superior to sodium bicarbonate and N-acetylcysteine in preventing contrast-induced acute kidney injury in high-risk patients.
URL: http://www.clinicaltrial.gov. Unique identifier: NCT01098032.
RenalGuard 系统可产生高尿输出量和液体平衡，可能有助于预防对比剂诱导的急性肾损伤。
对比剂诱导的急性肾损伤后试验 II（REMEDIAL II）试验是一项随机、多中心、研究者驱动的试验，旨在针对高危患者预防对比剂诱导的急性肾损伤。估计肾小球滤过率≤30 mL·min-1·1.73 m-2和/或风险评分≥11 的患者被随机分配至接受碳酸氢钠和 N-乙酰半胱氨酸（对照组）或接受 RenalGuard 系统控制的生理盐水和 N-乙酰半胱氨酸联合呋塞米（RenalGuard 组）水化治疗。主要终点是在术后 48 小时血清肌酐浓度升高≥0.3 mg/dL。次要终点包括血清胱抑素 C 动力学和住院期间透析率。RenalGuard 组 146 例患者中有 16 例（11%）发生对比剂诱导的急性肾损伤，对照组 146 例患者中有 30 例（20.5%）发生（比值比，0.47；95%置信区间，0.24 至 0.92）。有 142 例（48.5%）患者估计肾小球滤过率≤30 mL·min-1·1.73 m-2，有 149 例（51.5%）患者仅有风险评分≥11。根据纳入标准进行的亚组分析显示，不良事件的风险同样较低（估计肾小球滤过率≤30 mL·min-1·1.73 m-2：比值比，0.44；风险评分≥11：比值比，0.45；P 交互=0.97）。24 小时（0.02±0.32 与-0.08±0.26；P=0.002）和 48 小时（0.12±0.42 与 0.03±0.31；P=0.001）胱抑素 C 的变化以及住院期间透析率（4.1%与 0.7%；P=0.056）在对照组中更高。
RenalGuard 治疗在预防高危患者对比剂诱导的急性肾损伤方面优于碳酸氢钠和 N-乙酰半胱氨酸。
