Control of fluid balance guided by body composition monitoring in patients on peritoneal dialysis (COMPASS): study protocol for a randomized controlled trial

Seon Ha Baek, Kook-Hwan Oh, Sejoong Kim, Dong Ki Kim, Kwon-Wook Joo, Yun Kyu Oh, Byoung Geun Han, Jae Hyun Chang, Wookyung Chung, Yon Su Kim, Ki Young Na, Seon Ha Baek, Kook-Hwan Oh, Sejoong Kim, Dong Ki Kim, Kwon-Wook Joo, Yun Kyu Oh, Byoung Geun Han, Jae Hyun Chang, Wookyung Chung, Yon Su Kim, Ki Young Na

Abstract

Background: 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.

Discussion: 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.

Trial registration: Clinical Trials.gov number NCT01887262, June 24, 2013.

Figures

Figure 1
Figure 1
Study algorithm. BCM, body composition monitoring.
Figure 2
Figure 2
Hypervolemia management flow chart. APD, automated peritoneal dialysis; CAPD, continuous ambulatory peritoneal dialysis.
Figure 3
Figure 3
Hypovolemia management flow chart. APD, automated peritoneal dialysis; CAPD, continuous ambulatory peritoneal dialysis.

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