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
Trials
2014NA ; 15 ( 11 ) :432.
PMID : 25376940
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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 -
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.
Fluid balance Bioimpedance spectroscopy Peritoneal dialysis
MESH
Adult, Aged, *Body Composition, Clinical Protocols, Dielectric Spectroscopy, Electric Impedance, Female, Fluid Therapy/adverse effects/*methods, Glomerular Filtration Rate, Humans, Kidney/physiopathology, Kidney Diseases/diagnosis/physiopathology/*therapy, Male, Middle Aged, *Peritoneal Dialysis/adverse effects, Predictive Value of Tests, Prospective Studies, Republic of Korea, *Research Design, Time Factors, Treatment Outcome, *Water-Electrolyte Balance, Water-Electrolyte Imbalance/etiology/physiopathology/prevention & control, Young Adult
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