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Completed

NCT Number: NCT02000128

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

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.

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Key information

Conditions

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

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The First Affiliated Hospital of Sun Yat-Sen University

Guangzhou, Guangdong, 510080, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

bioimpedance monitoring

Device

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

Other names: Multi-frequency bioelectrical impedance analysis, Body Composition Analyzer

clinical monitoring

Other

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

Other names: routine method of assessing water status

Primary outcomes

  1. death

    Time frame: 12 months

    all cause mortality;cardiovascular related mortality

Secondary outcomes

  1. technique failure

    Time frame: 12 months

    permanent hemodialysis transfer

  2. cardiovascular events

    Time frame: 12 months

    heart failure, myocardial infarction,angina, Percutaneous coronary stenting, coronary artery bypass grafting,

  3. clinical adverse events

    Time frame: 12 months

    hospitalization events due to overload; Non-PD related infection; PD related peritonitis; peripheral angiopathy

  4. residual renal function

    Time frame: 12 months

    change of baseline residual renal function, measured as residual glomerular filtration rate(rGFR) and urine volume

Sponsors and collaborators

Lead sponsor

Sun Yat-sen University

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Dec 3, 2013
Registry last updated
Apr 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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