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

NCT02000128 | Completed DMC

• 1 other identifier: SYSU-PD-BIA
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 1

Brief Summary

1. 1.Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management versus experiential way on clinical outcome in peritoneal dialysis patients.
2. 2.Design: prospective,randomized,controlled,single center study
3. 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. 4.Objects: incident and prevalent patients with overhydration status.
5. 5.anticipated cases:240
6. 6.arms: all the patients are randomized into two arms.(BIA group/clinical group)
7. 7.observational time:12 months
8. 8.Primary Outcome: all cause mortality. Secondary Outcomes: technique survival, cardiovascular events, peritonitis, residual renal function.

Conditions

End Stage Renal Disease

Keywords

Peritoneal Dialysis; fluid overload; bioimpedance analysis; Randomized Controlled Trial

Outcome Measures

Primary Outcomes (1)

• death

  all cause mortality;cardiovascular related mortality

  12 months

Secondary Outcomes (4)

• technique failure

  12 months

• cardiovascular events

  12 months

• clinical adverse events

  12 months

• residual renal function

  12 months

Study Arms (2)

bioimpedance monitoring group

EXPERIMENTAL

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

Device: bioimpedance monitoring

clinical monitoring group

OTHER

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

Other: clinical monitoring

Interventions

bioimpedance monitoring DEVICE

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

Also known as: Multi-frequency bioelectrical impedance analysis, Body Composition Analyzer

bioimpedance monitoring group

clinical monitoring OTHER

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

Also known as: routine method of assessing water status

clinical monitoring group

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients who are undergoing peritoneal dialysis and clinically stable for at least 3 months;
• Years and older;
• ratio extracellular water (ECW)/total body water(TBW)≧0.4;
• signed the informed consent

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sun Yat-sen University: lead

Study Sites (1)

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Edema

Interventions

Clinical Trials Data Monitoring Committees

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Professional Staff Committees; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Xuqing Yu, MD,PHD

  First Affiliated Hospital, Sun Yat-Sen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Institute of Nephrology, Sun Yat-sen University

Study Record Dates

• First Submitted: November 26, 2013
• First Posted: December 3, 2013
• Study Start: November 1, 2013
• Primary Completion: April 1, 2015
• Study Completion: April 1, 2015
• Last Updated: April 20, 2016

Record last verified: 2016-04

Locations

CN (1)