Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients.

NCT ID: NCT03004963

Last Updated: 2024-11-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 213 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2020-11-30

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.

Conditions

End Stage Renal Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

clinical group

evaluate the volume status just according to clinical indexes in this group.

Group Type: ACTIVE_COMPARATOR

clinical indexes

Intervention Type: DEVICE

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

clinical and BCM group

Both body composition monitor (BCM) and clinical indexes are used to evaluate the volume status of patients in this group.

Group Type: EXPERIMENTAL

Body composition monitor

Intervention Type: DEVICE

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

clinical indexes

Intervention Type: DEVICE

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

Interventions

Body composition monitor

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

Intervention Type: DEVICE

clinical indexes

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

RenJi Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wei Fang, Dr

Role: PRINCIPAL_INVESTIGATOR

Department of Nephrology, Renji Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai

Locations

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

Shanghai, Shanghai Municipality, China

Countries

China

Other Identifiers

[2016]101K

Identifier Type: -

Identifier Source: org_study_id