Fluid Management Guided by Bioimpedance Analysis in Peritoneal Dialysis(PD) Patients.
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|ClinicalTrials.gov Identifier: NCT02000128|
Recruitment Status : Completed
First Posted : December 3, 2013
Last Update Posted : April 20, 2016
- Purpose: to investigate the effect of bioimpedance analysis(BIA) guided fluid management versus experiential way on clinical outcome in peritoneal dialysis patients.
- Design: prospective,randomized,controlled,single center study
- 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.
Objects: incident and prevalent patients with overhydration status.
- anticipated cases:240
- arms: all the patients are randomized into two arms.(BIA group/clinical group)
- observational time:12 months
- Primary Outcome: all cause mortality. Secondary Outcomes: technique survival, cardiovascular events, peritonitis, residual renal function.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Device: bioimpedance monitoring Other: clinical monitoring||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||240 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized Controlled Study of Bioimpedance Analysis(BIA) Guided Fluid Management in Peritoneal Dialysis Patients.|
|Study Start Date :||November 2013|
|Actual Primary Completion Date :||April 2015|
|Actual Study Completion Date :||April 2015|
Experimental: bioimpedance monitoring group
patients whose fluid status will be monitored and guided by bioimpedance analysis
Device: bioimpedance monitoring
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
Other: clinical monitoring
clinical symptom and examination,such as edema, body weight, blood pressure, cardial function
Other Name: routine method of assessing water status
- death [ Time Frame: 12 months ]all cause mortality;cardiovascular related mortality
- technique failure [ Time Frame: 12 months ]permanent hemodialysis transfer
- cardiovascular events [ Time Frame: 12 months ]heart failure, myocardial infarction,angina, Percutaneous coronary stenting, coronary artery bypass grafting,
- clinical adverse events [ Time Frame: 12 months ]hospitalization events due to overload; Non-PD related infection; PD related peritonitis; peripheral angiopathy
- residual renal function [ Time Frame: 12 months ]change of baseline residual renal function, measured as residual glomerular filtration rate(rGFR) and urine volume
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02000128
|The First Affiliated Hospital of Sun Yat-Sen University|
|GuangZhou, Guangdong, China, 510080|
|Principal Investigator:||Xuqing Yu, MD,PHD||First Affiliated Hospital, Sun Yat-Sen University|