Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients
Primary Purpose
Chronic Kidney Disease, Peritoneal Dialysis
Status
Withdrawn
Phase
Phase 4
Locations
Hong Kong
Study Type
Interventional
Intervention
treatment arm
Control arm
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring cardiovascular disease, hypertension
Eligibility Criteria
Inclusion Criteria:
- asymptomatic fluid overload, defined as overhydration (OH) ≥ 2 liters as measured by bioimpedance spectroscopy
Exclusion Criteria:
- clinical symptoms of fluid overload (including, but not restricted to, dyspnea on exertion, peripheral edema, pulmonary congestion)
- overt pulmonary edema and required urgent medical care
- cognitive impairment or problem of communication
- unlikely to survive for more than three months
- mechanical problems of the dialysis catheter
- active peritonitis or peritoneal failure
Sites / Locations
- Prince of Wales Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
treatment arm
control arm
Arm Description
active fluid management includes 3 components: dietary counseling, diuretics, and intensive dialysis regimen
dietary counseling alone
Outcomes
Primary Outcome Measures
blood pressure control
number of antihypertensive medications
duration of hospitalization for all cause
hospitalization for cardiovascular disease
Secondary Outcome Measures
degree of overhydration
change in residual GFR
nutritional status
arterial pulse wave velocity
cardiovascular mortality
all-cause mortality
Full Information
NCT ID
NCT02168283
First Posted
June 18, 2014
Last Updated
February 12, 2020
Sponsor
Chinese University of Hong Kong
1. Study Identification
Unique Protocol Identification Number
NCT02168283
Brief Title
Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients
Official Title
Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of funding
Study Start Date
December 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chinese University of Hong Kong
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
INTRODUCTION Peritoneal dialysis (PD) is a life-saving treatment for end-stage renal disease patients. However, cardiovascular disease remains the major cause of morbidity and mortality in PD patients. It is now realized that chronic asymptomatic intravascular hypervolemia is an important cause of cardiovascular disease in PD patients.
OBJECTIVES To determine the effects of treating asymptomatic fluid overload on blood pressure, hospitalization and cardiovascular morbidity in PD patients.
HYPOTHESIS The investigators hypothesize that treating asymptomatic fluid overload could improve the clinical outcome of PD patients.
DESIGN & SUBJECTS This is an open label randomized control trial. The investigators plan to recruit 60 PD patients with asymptomatic fluid overload, defined as overhydration (OH) ≥ 2 liters. Patients will be randomized to active fluid management (treatment arm) or conventional management (control arm).
STUDY INSTRUMENTS Overhydration will be identified by bioimpedance spectroscopy.
INTERVENTIONS For the treatment arm, active fluid management includes dietary counseling, diuretics, and intensive dialysis regimen. For the control arm, patients will only receive dietary counseling. Patients will be followed for one year.
MAIN OUTCOME MEASURES Blood pressure control, number of hospital admission and duration of hospitalization for all cause, and hospitalization for cardiovascular disease during the study period.
DATA ANALYSIS Blood pressure control will be compared by Student's t test. Hospitalization data will be compared by non-parametric Mann Whitney U test.
EXPECTED RESULTS The study will determine the benefit of treating asymptomatic fluid overload in PD patients.
Detailed Description
The investigators plan to recruit 60 PD patients with asymptomatic fluid overload, which is defined as overhydration (OH) ≥ 2 liters as measured by bioimpedance spectroscopy. Patients with clinical symptoms of fluid overload (including, but not restricted to, dyspnea on exertion, peripheral edema, pulmonary congestion) will be excluded. The investigators will also exclude patients who are in overt pulmonary edema and required urgent medical care, who have cognitive impairment or problem of communication, unlikely to survive for more than three months, have mechanical problems of the dialysis catheter, or have active peritonitis or peritoneal failure.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Peritoneal Dialysis
Keywords
cardiovascular disease, hypertension
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
treatment arm
Arm Type
Experimental
Arm Description
active fluid management includes 3 components: dietary counseling, diuretics, and intensive dialysis regimen
Arm Title
control arm
Arm Type
Active Comparator
Arm Description
dietary counseling alone
Intervention Type
Combination Product
Intervention Name(s)
treatment arm
Intervention Description
Hypertonic peritoneal dialysis cycles
Intervention Type
Behavioral
Intervention Name(s)
Control arm
Intervention Description
Dietary counseling
Primary Outcome Measure Information:
Title
blood pressure control
Time Frame
1 year
Title
number of antihypertensive medications
Time Frame
1 year
Title
duration of hospitalization for all cause
Time Frame
1 year
Title
hospitalization for cardiovascular disease
Time Frame
1 year
Secondary Outcome Measure Information:
Title
degree of overhydration
Time Frame
1 year
Title
change in residual GFR
Time Frame
1 year
Title
nutritional status
Time Frame
1 year
Title
arterial pulse wave velocity
Time Frame
1 year
Title
cardiovascular mortality
Time Frame
1 year
Title
all-cause mortality
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
cause of hospital admission
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
asymptomatic fluid overload, defined as overhydration (OH) ≥ 2 liters as measured by bioimpedance spectroscopy
Exclusion Criteria:
clinical symptoms of fluid overload (including, but not restricted to, dyspnea on exertion, peripheral edema, pulmonary congestion)
overt pulmonary edema and required urgent medical care
cognitive impairment or problem of communication
unlikely to survive for more than three months
mechanical problems of the dialysis catheter
active peritonitis or peritoneal failure
Facility Information:
Facility Name
Prince of Wales Hospital
City
Shatin
Country
Hong Kong
12. IPD Sharing Statement
Learn more about this trial
Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients
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