NCT03004963

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
213

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2016

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

December 12, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

December 29, 2016

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2020

Completed
Last Updated

November 22, 2024

Status Verified

November 1, 2024

Enrollment Period

4 years

First QC Date

December 12, 2016

Last Update Submit

November 19, 2024

Conditions

End Stage Renal Disease

Keywords

Peritoneal DialysisVolume StatusBody Composition Monitor

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (4)

  • blood pressure

    96 weeks

  • residual renal function

    96 weeks

  • peritoneal function

    96 weeks

  • heart function

    96 weeks

Study Arms (2)

clinical group

ACTIVE COMPARATOR

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

Device: clinical indexes

clinical and BCM group

EXPERIMENTAL

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

Device: Body composition monitorDevice: clinical indexes

Interventions

Body composition monitorDEVICE

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

clinical and BCM group
clinical indexesDEVICE

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

clinical and BCM groupclinical group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200127, China

Location

MeSH Terms

Conditions

Kidney Failure, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency, ChronicRenal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Wei Fang, Dr

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 12, 2016

First Posted

December 29, 2016

Study Start

November 1, 2016

Primary Completion

November 1, 2020

Study Completion

November 1, 2020

Last Updated

November 22, 2024

Record last verified: 2024-11

Locations

CN(1)