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

End Stage Renal Disease Clinical Trial

Official title:

A Prospective, Randomized Controlled Study of Bioimpedance Analysis(BIA) Guided Fluid Management in Peritoneal Dialysis Patients.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02000128
• Other study ID #: SYSU-PD-BIA
• Status: Completed
• Phase: N/A
• First received: November 26, 2013
• Last updated: April 19, 2016
• Start date: November 2013
• Est. completion date: April 2015

Study information

• Verified date: April 2016
• Source: Sun Yat-sen University
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 240
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Device:
• bioimpedance monitoring
To assess the body composition using Multi-frequency bioelectrical impedance analysis

Other:
• clinical monitoring
clinical symptom and examination,such as edema, body weight, blood pressure, cardial function

Locations

Country	Name	City	State
China	The First Affiliated Hospital of Sun Yat-Sen University	GuangZhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Sun Yat-sen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	death	all cause mortality;cardiovascular related mortality	12 months	No
Secondary	technique failure	permanent hemodialysis transfer	12 months	No
Secondary	cardiovascular events	heart failure, myocardial infarction,angina, Percutaneous coronary stenting, coronary artery bypass grafting,	12 months	No
Secondary	clinical adverse events	hospitalization events due to overload; Non-PD related infection; PD related peritonitis; peripheral angiopathy	12 months	No
Secondary	residual renal function	change of baseline residual renal function, measured as residual glomerular filtration rate(rGFR) and urine volume	12 months	Yes