Dataset Information

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

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.

SUBMITTER: Baek SH

PROVIDER: S-EPMC4233087 | biostudies-literature | 2014 Nov

REPOSITORIES: biostudies-literature

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Publications

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

Baek Seon Ha SH Oh Kook-Hwan KH Kim Sejoong S Kim Dong Ki DK Joo Kwon-Wook KW Oh Yun Kyu YK Han Byoung Geun BG Chang Jae Hyun JH Chung Wookyung W Kim Yon Su YS Na Ki Young KY

Trials 20141106

<h4>Background</h4>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.<h4 ...[more]

PMID: 25376940

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Project description:This article presents a dataset of body composition in chronic kidney disease (CKD) non-dialysis-dependent (NDD), hemodialysis (HD) and peritoneal dialysis (PD) (for at least 3 months), and kidney transplantation (KTx) (for at least 6 months) patients. The data were collected as part of a PhD research project, an observational cross-sectional study followed by a prospective analysis (about 6 months later). Adult CKD patients (18≤age≤60 years old) from a tertiary hospital were recruited: CKD in stages 3b to 5 for NDD patients; PD patients without peritonitis in the last 30 days; HD patients in 4-hour dialysis session, 3 times per week, through an arteriovenous fistula; and KTx patients with CKD in stages 1 to 3a. Patients with presence of amputated limbs or an electronic implant, wheelchair user or inpatient, body weight above 140 kg or BMI higher than 40 kg/m2, acute infections, cancer diagnosis, acquired immunodeficiency syndrome, and others that could alter body composition were excluded. The dataset in this publication consist of some clinical measurements for characterization of the sample, body composition measurements by dual-energy X-ray absorptiometry and by bioelectrical impedance spectroscopy in tetra-polar whole-body wrist to ankle (BISWB) and segmental (BISSEG) protocols of 266 CKD patients, being 137 men and 129 women; 81 in NDD treatment, 83 in HD, 24 in PD, and 80 in KTx. Measurements were performed consecutively by the same professional after an 8-hour fast, empty urinary bladder, drainage of the peritoneal dialysate, and just after the midweek hemodialysis session. To analyze differences among subgroups according to sex and CKD treatment, unpaired T test or ANOVA and Chi-square, adjusted by Bonferroni post-test, were applied. Agreement in fat free mass and fat mass measurements between BISWB and BISSEG, for cross-sectional data and for body composition changes (prospective measurement - cross-sectional measurement), was checked using intraclass correlation coefficient and 95% confidence intervals. Agreement on individual level was evaluated using the Bland-Altman method with limits of agreement. The data can be valuable in the study of body composition in CKD under all types of treatment and also for agreement analysis among body composition measurements by different instruments and techniques. The data are analysed and interpreted in the research article Bellafronte et al., 2020 [1].

Project description:Objective: The nutritional status of patients on peritoneal dialysis (PD) is influenced by patient- and disease-related factors and lifestyle. This analysis evaluated the association of PD prescription with body composition and patient outcomes in the prospective incident Initiative for Patient Outcomes in Dialysis-Peritoneal Dialysis (IPOD-PD) patient cohort. Design and Methods: In this observational, international cohort study with longitudinal follow-up of 1,054 incident PD patients, the association of PD prescription with body composition was analyzed by using the linear mixed models, and the association of body composition with death and change to hemodialysis (HD) by means of a competing risk analysis combined with a spline analysis. Body composition was regularly assessed with the body composition monitor, a device applying bioimpedance spectroscopy. Results: Age, time on PD, and the use of hypertonic and polyglucose solutions were significantly associated with a decrease in lean tissue index (LTI) and an increase in fat tissue index (FTI) over time. Competing risk analysis revealed a U-shaped association of body mass index (BMI) with the subdistributional hazard ratio (HR) for risk of death. High LTI was associated with a lower subdistributional HR, whereas low LTI was associated with an increased subdistributional HR when compared with the median LTI as a reference. High FTI was associated with a higher subdistributional HR when compared with the median as a reference. Subdistributional HR for risk of change to HD was not associated with any of the body composition parameters. The use of polyglucose or hypertonic PD solutions was predictive of an increased probability of change to HD, and the use of biocompatible solutions was predictive of a decreased probability of change to HD. Conclusion: Body composition is associated with non-modifiable patient-specific and modifiable treatment-related factors. The association between lean tissue and fat tissue mass and death and change to HD in patients on PD suggests developing interventions and patient counseling to improve nutritional markers and, ultimately, patient outcomes. Study Registration: The study has been registered at Clinicaltrials.gov (NCT01285726).

Dataset Information

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

Background

Methods/design

Discussion

Trial registration

Publications

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

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