A Prospective, Randomized Controlled Study of Bioimpedance Analysis(BIA) Guided Fluid Management in Peritoneal Dialysis Patients.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 240
- Locations
- 1
- Primary Endpoint
- death
Study Overview
Brief Summary
-
Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management versus experiential way on clinical outcome in peritoneal dialysis patients.
-
Design: prospective,randomized,controlled,single center study
-
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.
-
Objects: incident and prevalent patients with overhydration status.
-
anticipated cases:240
-
arms: all the patients are randomized into two arms.(BIA group/clinical group)
-
observational time:12 months
-
Primary Outcome: all cause mortality. Secondary Outcomes: technique survival, cardiovascular events, peritonitis, residual renal function.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 80 Years (Adult, Older Adult)
- Sex
- All
- Accepts 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.
Outcomes
Primary Outcomes
death
Time Frame: 12 months
all cause mortality;cardiovascular related mortality
Secondary Outcomes
- cardiovascular events(12 months)
- clinical adverse events(12 months)
- technique failure(12 months)
- residual renal function(12 months)
Investigators
Xue Qing Yu
Director, Institute of Nephrology, Sun Yat-sen University
Sun Yat-sen University