Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients.

RenJi Hospital213 enrolled

Overview

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.

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

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

213

Conditions

End Stage Renal Disease

Interventions

Body composition monitorDEVICE

Both body composition monitor (BCM) is used to evaluate the volume status of patients.

clinical indexesDEVICE

The investigators evaluate the volume status of patients according to clinical indexes.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 80 Years

Medical Language ↔ Plain English

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.

Locations (1)

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

Shanghai, Shanghai Municipality, China

Outcomes

Primary Outcomes

volume status

change in overhydration(OH) value

Time frame: 96 weeks

The incidence of cardiovascular events

different incidence of cardiovascular diseases

Time frame: 96 weeks

patient mortality

different rates of all-cause patient mortality and cardiovascular mortality

Time frame: 96 weeks

technique failure

different incidence of technique failure during peritoneal dialysis treatment

Time frame: 96 weeks

Secondary Outcomes

blood pressure

change in blood pressure

Time frame: 96 weeks

residual renal function

decline rate of residual renal function

Time frame: 96 weeks

peritoneal function

differences of peritoneal solute transport rate

Time frame: 96 weeks

heart function

differences of ejection fraction (EF) in echocardiography

Time frame: 96 weeks

Data from ClinicalTrials.gov

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