Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients
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|ClinicalTrials.gov Identifier: NCT02168283|
Recruitment Status : Withdrawn (Lack of funding)
First Posted : June 20, 2014
Last Update Posted : February 17, 2020
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.
|Condition or disease||Intervention/treatment||Phase|
|Chronic Kidney Disease Peritoneal Dialysis||Combination Product: treatment arm Behavioral: Control arm||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||0 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients|
|Study Start Date :||December 2015|
|Actual Primary Completion Date :||September 2017|
|Actual Study Completion Date :||September 2018|
Experimental: treatment arm
active fluid management includes 3 components: dietary counseling, diuretics, and intensive dialysis regimen
Combination Product: treatment arm
Hypertonic peritoneal dialysis cycles
Behavioral: Control arm
Active Comparator: control arm
dietary counseling alone
Behavioral: Control arm
- blood pressure control [ Time Frame: 1 year ]
- number of antihypertensive medications [ Time Frame: 1 year ]
- duration of hospitalization for all cause [ Time Frame: 1 year ]
- hospitalization for cardiovascular disease [ Time Frame: 1 year ]
- degree of overhydration [ Time Frame: 1 year ]
- change in residual GFR [ Time Frame: 1 year ]
- nutritional status [ Time Frame: 1 year ]
- arterial pulse wave velocity [ Time Frame: 1 year ]
- cardiovascular mortality [ Time Frame: 1 year ]
- all-cause mortality [ Time Frame: 1 year ]
- cause of hospital admission [ Time Frame: 1 year ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168283
|Prince of Wales Hospital|
|Shatin, Hong Kong|