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

NCT02000128 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 240

Last updated 2016-04-20

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Sun Yat-sen University

    lead OTHER

Principal Investigators

  • Xuqing Yu, MD,PHD · First Affiliated Hospital, Sun Yat-Sen University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • China

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02000128 on ClinicalTrials.gov