Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients.

Not Applicable

Completed

• Conditions: End Stage Renal Disease
• Interventions: Device: clinical indexes; Device: Body composition monitor

• Registration Number: NCT03004963
• Lead Sponsor: RenJi Hospital

Brief Summary

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.

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 Timeline

• Study Start: 2016-11
• Study First Submitted: 2016-12-12
• Study First Submitted QC: 2016-12-28
• Study First Posted: 2016-12-29
• Primary Completion: 2020-11
• Study Completion: 2020-11
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-19
• Last Update Posted: 2024-11-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 213

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
clinical group	clinical indexes	evaluate the volume status just according to clinical indexes in this group.
clinical and BCM group	Body composition monitor	Both body composition monitor (BCM) and clinical indexes are used to evaluate the volume status of patients in this group.
clinical and BCM group	clinical indexes	Both body composition monitor (BCM) and clinical indexes are used to evaluate the volume status of patients in this group.

Primary Outcome Measures

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

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine; 🇨🇳 Shanghai, Shanghai, China