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

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Other: clinical monitoring; Device: bioimpedance monitoring

• Registration Number: NCT02000128
• Lead Sponsor: Sun Yat-sen University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-26
• Study First Submitted QC: 2013-11-26
• Study First Posted: 2013-12-03
• Primary Completion: 2015-04
• Study Completion: 2015-04
• Status Verified: 2016-04
• Last Update Submitted: 2016-04-19
• Last Update Posted: 2016-04-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 240

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clinical monitoring group	clinical monitoring	patients whose fluid status will be monitored and guided by clinical experience
bioimpedance monitoring group	bioimpedance monitoring	patients whose fluid status will be monitored and guided by bioimpedance analysis

Primary Outcome Measures

Name	Time	Method
death	12 months	all cause mortality;cardiovascular related mortality

Secondary Outcome Measures

Name	Time	Method
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
technique failure	12 months	permanent hemodialysis transfer
residual renal function	12 months	change of baseline residual renal function, measured as residual glomerular filtration rate(rGFR) and urine volume

Trial Locations

Locations (1)

The First Affiliated Hospital of Sun Yat-Sen University; 🇨🇳 GuangZhou, Guangdong, China