End Stage Renal Disease
Conditions
Keywords
Peritoneal Dialysis, fluid overload, bioimpedance analysis, Randomized Controlled Trial
Brief summary
1. Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management versus experiential way on clinical outcome in peritoneal dialysis patients. 2. Design: prospective,randomized,controlled,single center study 3. Study hypothesis: Patients on peritoneal dialysis are frequently hypervolemic, which is associated with increasing hazard of death and cardiovascular events. Bioimpedance analysis is a safe, and easy way, which appears to be more useful and sensitive than other techniques for assessing volume status in dialysis patients. Therefore we hypothesize that more concise and strict fluid management guided by BIA may help to improve patients' survival, decrease cardiovascular events and hospitalization rate. 4. Objects: incident and prevalent patients with overhydration status. 1. anticipated cases:240 2. arms: all the patients are randomized into two arms.(BIA group/clinical group) 3. observational time:12 months 5. Primary Outcome: all cause mortality. Secondary Outcomes: technique survival, cardiovascular events, peritonitis, residual renal function.
Interventions
DEVICEbioimpedance monitoring
To assess the body composition using Multi-frequency bioelectrical impedance analysis
OTHERclinical monitoring
clinical symptom and examination,such as edema, body weight, blood pressure, cardial function
Sponsors
Sun Yat-sen University
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 who are undergoing peritoneal dialysis and clinically stable for at least 3 months; * 18 Years and older; * ratio extracellular water (ECW)/total body water(TBW)≧0.4; * signed the informed consent
Exclusion criteria
* patients who have mental graft; * amputation; * patients who is unable to accomplish the BIA measurement in standing position for 3 minutes; * patients whose heart function are class IV estimated by New York Heart Association (NYHA) standard; * Patients who have acute complications within 30 days prior to study enrollment; * patients whose life expectancy is within 6 months; * patients who are pregnant; * patients who are unable to give consent.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| death | 12 months | all cause mortality;cardiovascular related mortality |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| technique failure | 12 months | permanent hemodialysis transfer |
| cardiovascular events | 12 months | heart failure, myocardial infarction,angina, Percutaneous coronary stenting, coronary artery bypass grafting, |
| clinical adverse events | 12 months | hospitalization events due to overload; Non-PD related infection; PD related peritonitis; peripheral angiopathy |
| residual renal function | 12 months | change of baseline residual renal function, measured as residual glomerular filtration rate(rGFR) and urine volume |
Countries
China
Outcome results
None listed