Harvard Medical School, Boston, MA, USA.
Int J Cardiol. 2013 Jun 20;166(2):482-6. doi: 10.1016/j.ijcard.2011.11.035. Epub 2011 Dec 26.
Contrast-induced nephropathy (CIN) is a frequent complication following angiographic procedures with significant impact on healthcare costs, and long-term outcomes. Multiple reno-protective strategies have been studied but few have shown benefit in prospective randomized studies beyond limiting the exposure to iodinated contrast and adequate intravenous. We studied the performance and safety of a novel system designed to achieve precise real-time high volume fluid balance using a closed loop hydration monitoring and infusion system.
This prospective, multi-center, FDA approved phase II feasibility study was designed to evaluate the safety and the performance of the RenalGuard matched hydration system. Between October 2006 and November 2007, twenty-three subjects at high risk for CIN (with an estimated glomerular filtration rate (eGFR)<50ml/min/1.73m(2)) undergoing diagnostic or therapeutic catheterization were treated with the system. The primary endpoint of the study was defined as the ability of the system to effectively dynamically match fluid administration to urine output.
The 23 subjects at high risk for CIN enrolled had a mean±SD eGFR of 39±9.3. Patients achieved an hourly urine flow rate of 620±400ml/h. The system had a mean effectiveness rate of 99.9% over the duration of therapy with an average saline volume infused of 3825ml closely matched, minute to minute, to urine output of 3579ml. There were no major device-related complications from the experimental therapy, though one patient developed hypokalemia requiring replacement. Two subjects (9.5%) developed CIN as defined by >0.5mg/dl or >25% rise in serum creatinine at 48-60h post contrast administration when compared with the baseline.
The study confirmed that the RenalGuard(TM) system is safe and dynamically balances volume hydration with urine production. Further randomized studies are needed to confirm the efficacy of the system in reducing the incidence of CIN.
造影剂肾病（CIN）是血管造影术后常见的并发症，对医疗成本和长期预后有重大影响。已经研究了多种肾脏保护策略，但除了限制碘造影剂和充分的静脉补液外，很少有前瞻性随机研究显示出益处。我们研究了一种新系统的性能和安全性，该系统旨在使用闭环水合监测和输液系统实现精确的实时高容量液体平衡。
这是一项前瞻性、多中心、FDA 批准的 II 期可行性研究，旨在评估 RenalGuard 匹配水合系统的安全性和性能。在 2006 年 10 月至 2007 年 11 月期间，23 名患有 CIN 高风险（估计肾小球滤过率[eGFR]＜50ml/min/1.73m²）的患者接受了该系统治疗。该研究的主要终点定义为系统有效动态匹配液体输注与尿液输出的能力。
23 名患有 CIN 高风险的患者平均 eGFR 为 39±9.3。患者实现了每小时 620±400ml/h 的尿量。在整个治疗期间，该系统的平均有效率为 99.9%，平均输注盐水体积为 3825ml，与 3579ml 的尿液输出量密切匹配，每分钟都匹配。尽管有一名患者出现低钾血症需要替代治疗，但实验治疗没有发生主要与设备相关的并发症。两名患者（9.5%）在造影后 48-60 小时，根据基线血清肌酐升高＞0.5mg/dl 或＞25%，定义为 CIN。
该研究证实了 RenalGuard（TM）系统是安全的，并能动态平衡容量水合与尿液生成。需要进一步的随机研究来确认该系统在降低 CIN 发生率方面的疗效。
