Baek Seon Ha, Oh Kook-Hwan, Kim Sejoong, Kim Dong Ki, Joo Kwon-Wook, Oh Yun Kyu, Han Byoung Geun, Chang Jae Hyun, Chung Wookyung, Kim Yon Su, Na Ki Young
Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam 463-707, Gyeonggi-do, South Korea.
Trials. 2014 Nov 6;15:432. doi: 10.1186/1745-6215-15-432.
The clinical benefits of bioimpedance spectroscopy (BIS)-guided fluid management in patients on hemodialysis have been widely demonstrated. However, no previous reports have evaluated the effect of regular and serial BIS-guided fluid management on the residual renal function (RRF) in patients on peritoneal dialysis (PD). Therefore, we will evaluate the clinical efficacy of BIS-guided fluid management for preserving RRF and protecting cardiovascular events in patients on PD.
METHODS/DESIGN: This is a multicenter, prospective, randomized controlled trial. A total of 138 participants on PD will be enrolled and randomly assigned to receive either BIS-guided fluid management or fluid management based only on the clinical information for 1 year. The primary outcome is the change in the glomerular filtration rate (GFR) between months 0 and 12 after starting treatment. The secondary outcomes will include GFR at month 12, time to the anuric state (urine volume <100 ml/day), and fatal and nonfatal cardiovascular events during treatment.
This is the first clinical trial to investigate the effect of BIS-guided fluid management on RRF and for protecting against cardiovascular events in patients on PD.
Clinical Trials.gov number NCT01887262, June 24, 2013.
生物电阻抗光谱法（BIS）指导下的液体管理对血液透析患者的临床益处已得到广泛证实。然而，此前尚无报告评估定期和连续的BIS指导下的液体管理对腹膜透析（PD）患者残余肾功能（RRF）的影响。因此，我们将评估BIS指导下的液体管理对保护PD患者RRF及预防心血管事件的临床疗效。
方法/设计：这是一项多中心、前瞻性、随机对照试验。共招募138例PD患者，随机分为两组，分别接受BIS指导下的液体管理或仅基于临床信息的液体管理，为期1年。主要结局是开始治疗后0至12个月期间肾小球滤过率（GFR）的变化。次要结局将包括第12个月时的GFR、无尿状态（尿量<100 ml/天）的时间以及治疗期间的致命和非致命心血管事件。
这是第一项研究BIS指导下的液体管理对PD患者RRF的影响以及预防心血管事件的临床试验。
ClinicalTrials.gov编号NCT01887262，2013年6月24日。
