Laboratory of Interventional Cardiology and Department of Cardiology, Clinica Mediterranea, Naples, Italy.
EuroIntervention. 2011 Apr;6(9):1117-22, 7. doi: 10.4244/EIJV6I9A194.
The combined prophylactic strategy of sodium bicarbonate plus N-acetylsyteine (NAC) seems to be effective in preventing contrast induced acute kidney injury (CI-AKI) in patients at low-to-medium risk. However, in patients at high and very high risk the rate of CI-AKI is still high. In this subset of patients the anticipated advantages of the RenalGuard(tm) System should be investigated. The RenalGuard(tm) System (PLC Medical Systems, Inc., Franklin, MA, USA) is a real-time measurement and real time matched fluid replacement device designed to accommodate the RenalGuard therapy, which is based on the theory that creating and maintaining a high urine output is beneficial by allowing a quick elimination of contrast media, and, therefore, reducing its toxic effects.
The REMEDIAL II trial is a randomised, multicentre, investigator-sponsored trial addressing the hypothesis that the RenalGuard System is superior to the prophylaxis with sodium bicarbonate infusion plus NAC in preventing CI-AKI in high and very high risk patients. Consecutive patients with chronic kidney disease (CKD) and at high to very high risk for CI-AKI, referred to our institutions for coronary and/or peripheral procedures, will be randomly assigned to 1) prophylactic administration of sodium bicarbonate plus NAC (control group) and 2) RenalGuard System treatment (RenalGuard group). All enrolled patients must have an estimated glomerular filtration rate ≤ 30 ml/min/1.73 m2 and/or a contrast nephropathy risk score ≥ 11. In all cases iodixanol (an iso-osmolar, non-ionic contrast agent) will be administered. The primary endpoint is an increase of ≥ 0.3 mg/dL in the serum creatinine concentration 48 hours after the procedure.
The REMEDIAL II trial will give important answers on how to prevent CI-AKI in high and very high risk patients undergoing contrast media exposure.
碳酸氢钠联合 N-乙酰半胱氨酸（NAC）的联合预防策略似乎能有效预防低-中危患者的造影剂诱导急性肾损伤（CI-AKI）。然而，在高风险和极高风险患者中，CI-AKI 的发生率仍然很高。在这部分患者中，应探讨 RenalGuard（tm）系统的预期优势。RenalGuard（tm）系统（PLC Medical Systems，Inc.， Franklin，MA，USA）是一种实时测量和实时匹配液体替代设备，旨在适应 RenalGuard 治疗，其理论依据是创造和维持高尿量有益，因为可以快速排出造影剂，从而降低其毒性作用。
REMEDIAL II 试验是一项随机、多中心、研究者发起的试验，旨在验证假设，即 RenalGuard 系统在预防高风险和极高风险患者的 CI-AKI 方面优于碳酸氢钠输注联合 NAC 的预防。连续患有慢性肾脏病（CKD）且高至极高风险发生 CI-AKI 的患者，因冠状动脉和/或外周手术而被转至我们的机构，将被随机分配到 1）预防性给予碳酸氢钠联合 NAC（对照组）和 2）RenalGuard 系统治疗（RenalGuard 组）。所有入组患者的估算肾小球滤过率（eGFR）必须≤30ml/min/1.73m2，且/或造影剂肾病风险评分≥11。在所有情况下，均给予碘克沙醇（一种等渗、非离子型造影剂）。主要终点是术后 48 小时血清肌酐浓度升高≥0.3mg/dL。
REMEDIAL II 试验将为如何预防高风险和极高风险接受造影剂暴露的患者发生 CI-AKI 提供重要答案。
