Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients.

Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients: A Randomized Controlled Trial

Peritoneal dialysis (PD) is one of established treatments in the end stage renal disease patients. Volume overload is a predictor of mortality in PD patients. In this Randomized controlled trial, the investigators use the Body Composition Monitor (BCM), a multifrequency bioimpedance device, to measure the level of overhydration in PD patients and explore its value in fluid management in peritoneal dialysis patients as well as their prognosis.

Study Overview

• Status: Completed
• Conditions: End Stage Renal Disease
• Intervention / Treatment: Device: clinical indexes; Device: Body composition monitor

Detailed Description

Optimal fluid management is one of the primary objectives of dialysis treatment, and there is significant concern that peritoneal dialysis (PD) patients can become progressively fluid-loaded with time on treatment, especially as residual kidney function declines. Body Composition Monitor (BCM) has the potential to enable better management of fluid balance. The investigators undertake a prospective, randomized, open-label, controlled trial to determine whether availability of longitudinal BCM measures help clinicians maintain stable fluid status over 24 months in 300 peritoneal dialysis patients.

• Study Type: Interventional
• Enrollment (Actual): 213
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200127
      • Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Patients 18 years or older but no older than 80 years.
• who had been on chronic peritoneal dialysis for more than 3 months.
• All of them have signed the informed consent.

Exclusion Criteria:

• were expected to stop PD treatment in 6 months;
• were amputees;
• had a cardiac pacemaker or metallic implants;
• had peritonitis one month before recruitment;
• treated together with hemodialysis;
• were during pregnancy or lactation;
• were positive with HIV;
• had serious diseases, including cancer, infection and liver cirrhosis, which were not suitable for the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: clinical group; evaluate the volume status just according to clinical indexes in this group.	Device: clinical indexes; The investigators evaluate the volume status of patients according to clinical indexes.
Experimental: clinical and BCM group; Both body composition monitor (BCM) and clinical indexes are used to evaluate the volume status of patients in this group.	Device: clinical indexes; The investigators evaluate the volume status of patients according to clinical indexes.; Device: Body composition monitor; Both body composition monitor (BCM) is used to evaluate the volume status of patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
volume status	change in overhydration(OH) value	96 weeks
The incidence of cardiovascular events	different incidence of cardiovascular diseases	96 weeks
patient mortality	different rates of all-cause patient mortality and cardiovascular mortality	96 weeks
technique failure	different incidence of technique failure during peritoneal dialysis treatment	96 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
blood pressure	change in blood pressure	96 weeks
residual renal function	decline rate of residual renal function	96 weeks
peritoneal function	differences of peritoneal solute transport rate	96 weeks
heart function	differences of ejection fraction (EF) in echocardiography	96 weeks

Collaborators and Investigators

• Sponsor: RenJi Hospital
• Investigators: Principal Investigator: Wei Fang, Dr, Department of Nephrology, Renji Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): November 1, 2020
• Study Completion (Actual): November 1, 2020

Study Registration Dates

• First Submitted: December 12, 2016
• First Submitted That Met QC Criteria: December 28, 2016
• First Posted (Estimated): December 29, 2016

Study Record Updates

• Last Update Posted (Actual): November 22, 2024
• Last Update Submitted That Met QC Criteria: November 19, 2024
• Last Verified: November 1, 2024

More Information

Terms related to this study

• Keywords: Peritoneal Dialysis; Volume Status; Body Composition Monitor
• Additional Relevant MeSH Terms: Urogenital Diseases; Pathologic Processes; Male Urogenital Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Chronic Disease; Disease Attributes; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: [2016]101K

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No