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

NCT ID: NCT02000128

Last Updated: 2016-04-20

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 240 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-11-30
• Study Completion Date: 2015-04-30

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

bioimpedance monitoring group

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

Group Type: EXPERIMENTAL

bioimpedance monitoring

Intervention Type: DEVICE

To assess the body composition using Multi-frequency bioelectrical impedance analysis

clinical monitoring group

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

Group Type: OTHER

clinical monitoring

Intervention Type: OTHER

clinical symptom and examination,such as edema, body weight, blood pressure, cardial function

Interventions

bioimpedance monitoring

To assess the body composition using Multi-frequency bioelectrical impedance analysis

Intervention Type: DEVICE

clinical monitoring

clinical symptom and examination,such as edema, body weight, blood pressure, cardial function

Intervention Type: OTHER

Other Intervention Names

Multi-frequency bioelectrical impedance analysis; Body Composition Analyzer; routine method of assessing water status

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Sun Yat-sen University

OTHER

Sponsor Role: lead

Responsible Party

Xue Qing Yu

Director, Institute of Nephrology, Sun Yat-sen University

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Xuqing Yu, MD,PHD

Role: PRINCIPAL_INVESTIGATOR

First Affiliated Hospital, Sun Yat-Sen University

Locations

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, China

Countries

China

Other Identifiers

SYSU-PD-BIA

Identifier Type: -

Identifier Source: org_study_id