End Stage Renal Disease
Conditions
Keywords
Peritoneal Dialysis, Volume Status, Body Composition Monitor
Brief summary
Peritoneal dialysis (PD) is one of established treatments in the end stage renal disease patients. Volume overload is a predictor of mortality in PD patients. In this Randomized controlled trial, the investigators use the Body Composition Monitor (BCM), a multifrequency bioimpedance device, to measure the level of overhydration in PD patients and explore its value in fluid management in peritoneal dialysis patients as well as their prognosis.
Detailed description
Optimal fluid management is one of the primary objectives of dialysis treatment, and there is significant concern that peritoneal dialysis (PD) patients can become progressively fluid-loaded with time on treatment, especially as residual kidney function declines. Body Composition Monitor (BCM) has the potential to enable better management of fluid balance. The investigators undertake a prospective, randomized, open-label, controlled trial to determine whether availability of longitudinal BCM measures help clinicians maintain stable fluid status over 24 months in 300 peritoneal dialysis patients.
Interventions
DEVICEBody composition monitor
Both body composition monitor (BCM) is used to evaluate the volume status of patients.
DEVICEclinical indexes
The investigators evaluate the volume status of patients according to clinical indexes.
Sponsors
RenJi Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Patients 18 years or older but no older than 80 years. * who had been on chronic peritoneal dialysis for more than 3 months. * All of them have signed the informed consent.
Exclusion criteria
* were expected to stop PD treatment in 6 months; * were amputees; * had a cardiac pacemaker or metallic implants; * had peritonitis one month before recruitment; * treated together with hemodialysis; * were during pregnancy or lactation; * were positive with HIV; * had serious diseases, including cancer, infection and liver cirrhosis, which were not suitable for the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| technique failure | 96 weeks | different incidence of technique failure during peritoneal dialysis treatment |
| volume status | 96 weeks | change in overhydration(OH) value |
| The incidence of cardiovascular events | 96 weeks | different incidence of cardiovascular diseases |
| patient mortality | 96 weeks | different rates of all-cause patient mortality and cardiovascular mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| blood pressure | 96 weeks | change in blood pressure |
| residual renal function | 96 weeks | decline rate of residual renal function |
| peritoneal function | 96 weeks | differences of peritoneal solute transport rate |
| heart function | 96 weeks | differences of ejection fraction (EF) in echocardiography |
Countries
China
Outcome results
None listed