Back to resultsBioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients.
Primary Purpose
End Stage Renal Disease
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Body composition monitor
clinical indexes
Sponsored by
About this trial
This is an interventional treatment trial for End Stage Renal Disease focused on measuring Peritoneal Dialysis, Volume Status, Body Composition Monitor
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.
Sites / Locations
- Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of MedicineRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
clinical group
clinical and BCM group
Arm Description
evaluate the volume status just according to clinical indexes in this group.
Both body composition monitor (BCM) and clinical indexes are used to evaluate the volume status of patients in this group.
Outcomes
Primary Outcome Measures
volume status
change in overhydration(OH) value
The incidence of cardiovascular events
different incidence of cardiovascular diseases
patient mortality
different rates of all-cause patient mortality and cardiovascular mortality
technique failure
different incidence of technique failure during peritoneal dialysis treatment
Secondary Outcome Measures
blood pressure
change in blood pressure
residual renal function
decline rate of residual renal function
peritoneal function
differences of peritoneal solute transport rate
heart function
differences of ejection fraction (EF) in echocardiography
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03004963
Brief Title
Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients.
Official Title
Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2016 (undefined)
Primary Completion Date
December 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
RenJi Hospital
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
End Stage Renal Disease
Keywords
Peritoneal Dialysis, Volume Status, Body Composition Monitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
clinical group
Arm Type
Active Comparator
Arm Description
evaluate the volume status just according to clinical indexes in this group.
Arm Title
clinical and BCM group
Arm Type
Experimental
Arm Description
Both body composition monitor (BCM) and clinical indexes are used to evaluate the volume status of patients in this group.
Intervention Type
Device
Intervention Name(s)
Body composition monitor
Intervention Description
Both body composition monitor (BCM) is used to evaluate the volume status of patients.
Intervention Type
Device
Intervention Name(s)
clinical indexes
Intervention Description
The investigators evaluate the volume status of patients according to clinical indexes.
Primary Outcome Measure Information:
Title
volume status
Description
change in overhydration(OH) value
Time Frame
96 weeks
Title
The incidence of cardiovascular events
Description
different incidence of cardiovascular diseases
Time Frame
96 weeks
Title
patient mortality
Description
different rates of all-cause patient mortality and cardiovascular mortality
Time Frame
96 weeks
Title
technique failure
Description
different incidence of technique failure during peritoneal dialysis treatment
Time Frame
96 weeks
Secondary Outcome Measure Information:
Title
blood pressure
Description
change in blood pressure
Time Frame
96 weeks
Title
residual renal function
Description
decline rate of residual renal function
Time Frame
96 weeks
Title
peritoneal function
Description
differences of peritoneal solute transport rate
Time Frame
96 weeks
Title
heart function
Description
differences of ejection fraction (EF) in echocardiography
Time Frame
96 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wei Fang, Dr
Phone
13621722995
Email
fangwei_sh@126.com
First Name & Middle Initial & Last Name or Official Title & Degree
Xiaoxiao Yang, Dr
Phone
18817314230
Email
yangxiaoxiao_1988@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wei Fang, Dr
Organizational Affiliation
Department of Nephrology, Renji Hospital, Shanghai Jiaotong University, School of Medicine, Shanghai
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of nephrology , Renji Hospital, Shanghai Jiao Tong University School of Medicine
City
Shanghai
State/Province
Shanghai
ZIP/Postal Code
200127
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wei Fang, Dr.
Phone
13621722995
Email
fangwei_sh@126.com
First Name & Middle Initial & Last Name & Degree
Wei Fang, Dr.
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Bioimpedance-guided Fluid Management in Chronic Peritoneal Dialysis Patients.
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