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

Baek SH, Oh KH, Kim S, Kim DK, Joo KW, Oh YK, Han BG, Chang JH, Chung W, Kim YS, Na KY - Trials (2014)

Bottom Line: The clinical benefits of bioimpedance spectroscopy (BIS)-guided fluid management in patients on hemodialysis have been widely demonstrated.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.

View Article: PubMed Central - PubMed

Affiliation: 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.

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.

Show MeSH
Study algorithm. BCM, body composition monitoring.
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Fig1: Study algorithm. BCM, body composition monitoring.

Mentions: The study is a multicenter, prospective, parallel-group, open-label, randomized controlled trial. It is an investigator-initiated clinical trial. The study algorithm is depicted in Figure 1. After enrollment, clinical follow-up will be performed after 0, 2, 4, 6, 8, 10, and 12 months of treatment.Figure 1


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

Baek SH, Oh KH, Kim S, Kim DK, Joo KW, Oh YK, Han BG, Chang JH, Chung W, Kim YS, Na KY - Trials (2014)

Study algorithm. BCM, body composition monitoring.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4233087&req=5

Fig1: Study algorithm. BCM, body composition monitoring.
Mentions: The study is a multicenter, prospective, parallel-group, open-label, randomized controlled trial. It is an investigator-initiated clinical trial. The study algorithm is depicted in Figure 1. After enrollment, clinical follow-up will be performed after 0, 2, 4, 6, 8, 10, and 12 months of treatment.Figure 1

Bottom Line: The clinical benefits of bioimpedance spectroscopy (BIS)-guided fluid management in patients on hemodialysis have been widely demonstrated.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.

View Article: PubMed Central - PubMed

Affiliation: 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.

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.

Show MeSH