Trials. 2014;15:432.
Control of fluid balance guided by body composition monitoring in patients on peritoneal dialysis (COMPASS): study protocol for a randomized controlled trial.
제1저자 백선하, 오국환 · 교신저자 나기영
소속 (1)
- 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.
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그림 출처: PubMed Central 공개 논문 (PMC4233087)
그 밖의 정보
- 출판 형태
- Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
- 저널
- Trials · eISSN 1745-6215
- 전자 출판
- 2014-11-06
- 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
- 데이터
- ClinicalTrials.gov: NCT01887262
- 참고문헌
- 27편