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


CONCLUSIONS
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.


BACKGROUND
Clinical Trials.gov number NCT01887262, June 24, 2013.
Seon Ha
SH
Baek
Kook-Hwan
KH
Oh
Sejoong
S
Kim
Dong Ki
DK
Kim
Kwon-Wook
KW
Joo
Yun Kyu
YK
Oh
Byoung Geun
BG
Han
Jae Hyun
JH
Chang
Wookyung
W
Chung
Yon Su
YS
Kim
Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173 Beon-gil, Bundang-gu, Seongnam 463-707, Gyeonggi-do, South Korea. kyna@snubh.org.
Ki Young
KY
Na
D000328:Adult; D000368:Aged; D001823:Body Composition; D002985:Clinical Protocols; D058266:Dielectric Spectroscopy; D017097:Electric Impedance; D005260:Female; D005440:Fluid Therapy / Q000009:adverse effects / Q000379:methods*; D005919:Glomerular Filtration Rate; D006801:Humans; D007668:Kidney / Q000503:physiopathology; D007674:Kidney Diseases / Q000175:diagnosis / Q000503:physiopathology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D010530:Peritoneal Dialysis / Q000009:adverse effects; D011237:Predictive Value of Tests; D011446:Prospective Studies; D056910:Republic of Korea; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D014882:Water-Electrolyte Balance; D014883:Water-Electrolyte Imbalance / Q000209:etiology / Q000503:physiopathology / Q000517:prevention & control; D055815:Young Adult