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VolumE maNagement Under body composition monitoring in critically ill patientS on CRRT: study protocol for a randomized controlled trial (VENUS trial)

机译:CRRT危重患者体内成分监测下的体积管理:随机对照试验的研究方案(金星审判)

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Despite recent technical advances in the management of acute kidney injury (AKI), such as continuous renal replacement therapy (CRRT), intensive care unit mortality is still high, at approximately 40 to 50%. Although several factors have been reported to predict mortality in AKI patients, fluid overload (FO) during CRRT is a well-known predictor of patient survival. However, FO has been mostly quantified as an arithmetical calculation and determined on the basis of the physicians' perception. Even though such quantification and assessment provides an easy evaluation of a patient's fluid status and is a simple method, it is not applicable unless a detailed record of fluid monitoring is available. Furthermore, the method cannot differentiate excess water in individual water compartments but can only reflect excess total body water. Bioimpedance analysis (BIA) has been used to measure the nutritional component of body composition and is a promising tool for the measurement of volume status. However, there has been no prospective interventional study for fluid balance among CRRT-treated AKI patients using BIA. Therefore, we will investigate the usefulness of fluid management using the InBody S10 (InBody?, Seoul, Korea), a BIA tool, compared with that of generally used quantification methods. This will be a multicenter, prospective, randomized controlled trial. A total of 244 patients undergoing CRRT treatment will be enrolled and randomly assigned to receive either to InBody S10-guided management or to fluid management based only on clinical information for 7?days. The primary outcome is to compare the rate of euvolemic status 7?days after the initiation of CRRT, with a secondary outcome being to compare the 28-, 60-, and 90-day mortality rates between the two groups. This will be the first clinical trial to investigate the effect of using BIA-guided fluid management to achieve euvolemia in CRRT-treated AKI patients. ClinicalTrials.gov, ID: NCT03330626 . Registered on 6 November 2017.
机译:尽管急性肾脏损伤(AKI)的近期技术进步​​,如连续肾替代治疗(CRRT),但重症监护单位死亡率仍然很高,约为40%至50%。虽然据报道了几个因素预测AKI患者的死亡率,但CRRT期间的流体过载(FO)是患者存活的众所周知的预测因子。然而,FO已经量化为算术计算,并根据医生的感知确定。尽管这种量化和评估提供了对患者的流体状态的简单评估并且是一种简单的方法,除非提供流体监测的详细记录,否则不适用。此外,该方法不能将多余的水区分开,但只能反射过量的总体水。生物阻抗分析(BIA)已被用于测量车身组成的营养成分,是测量体积状态的有希望的工具。然而,在使用BIA的CRRT治疗的AKI患者中,没有前瞻性介入研究流体平衡。因此,我们将研究流体管理的有用性使用BIA工具的Inbody S10(Inbody?,韩国),比亚工具相比,与通常使用的量化方法相比。这将是多中心,前瞻性随机对照试验。共有244名接受CRRT治疗的患者,并随机分配到Inbody S10引导管理或仅基于7个?天的临床信息的流体管理。主要结果是比较Euvly血统状态7的速率7?在CRRT开始后的一天,次要结果进行比较两组之间的28%,60-和90天的死亡率。这将是第一次调查使用BIA引导流体管理实现CRRT治疗的AKI患者Euvolemia的临床试验。 ClinicalTrials.gov,ID:NCT03330626。 2017年11月6日注册。

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