Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients

Conditions
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Chronic Kidney Disease, Peritoneal Dialysis

Intervention / Treatment
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* Combination Product: treatment arm
* Behavioral: Control arm


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 90 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment arm<br>active fluid management includes 3 components: dietary counseling, diuretics, and intensive dialysis regimen | Combination Product: treatment arm<br>* Hypertonic peritoneal dialysis cycles<br>Behavioral: Control arm<br>* Dietary counseling<br>|
| Active Comparator: control arm<br>dietary counseling alone | Behavioral: Control arm<br>* Dietary counseling<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood pressure control |  | 1 year | 
| number of antihypertensive medications |  | 1 year | 
| duration of hospitalization for all cause |  | 1 year | 
| hospitalization for cardiovascular disease |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| degree of overhydration |  | 1 year | 
| change in residual GFR |  | 1 year | 
| nutritional status |  | 1 year | 
| arterial pulse wave velocity |  | 1 year | 
| cardiovascular mortality |  | 1 year | 
| all-cause mortality |  | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cardiovascular disease, hypertension