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

Trials. 2014 Nov 6;15:432. doi: 10.1186/1745-6215-15-432.

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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Body Composition*
  • Clinical Protocols
  • Dielectric Spectroscopy
  • Electric Impedance
  • Female
  • Fluid Therapy / adverse effects
  • Fluid Therapy / methods*
  • Glomerular Filtration Rate
  • Humans
  • Kidney / physiopathology
  • Kidney Diseases / diagnosis
  • Kidney Diseases / physiopathology
  • Kidney Diseases / 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
  • Water-Electrolyte Imbalance / physiopathology
  • Water-Electrolyte Imbalance / prevention & control
  • Young Adult

Associated data

  • ClinicalTrials.gov/NCT01887262