Fluid Management Guided by Bioimpedance Analysis in Peritoneal Dialysis(PD) Patients.

Sun Yat-sen University

Status: Completed

Conditions: End Stage Renal Disease

Treatments: Device: bioimpedance monitoring; Other: clinical monitoring

Study type: Interventional

Funder types: Other

Identifiers

NCT02000128

SYSU-PD-BIA

Details and patient eligibility

About

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.

Enrollment: 240 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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240 participants in 2 patient groups

bioimpedance monitoring group

Experimental group

Description:

patients whose fluid status will be monitored and guided by bioimpedance analysis

Treatment:

Device: bioimpedance monitoring

clinical monitoring group

Other group

Description:

patients whose fluid status will be monitored and guided by clinical experience

Treatment:

Other: clinical monitoring