Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients

Phase 4

Withdrawn

• Conditions: Peritoneal Dialysis; Chronic Kidney Disease
• Interventions: Combination Product: treatment arm; Behavioral: Control arm

• Registration Number: NCT02168283
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2014-06-18
• Study First Submitted QC: 2014-06-18
• Study First Posted: 2014-06-20
• Study Start: 2015-12
• Primary Completion: 2017-09
• Study Completion: 2018-09
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-12
• Last Update Posted: 2020-02-17

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• asymptomatic fluid overload, defined as overhydration (OH) ≥ 2 liters as measured by bioimpedance spectroscopy

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
treatment arm	treatment arm	active fluid management includes 3 components: dietary counseling, diuretics, and intensive dialysis regimen
treatment arm	Control arm	active fluid management includes 3 components: dietary counseling, diuretics, and intensive dialysis regimen
control arm	Control arm	dietary counseling alone

Primary Outcome Measures

Name	Time	Method
blood pressure control	1 year
hospitalization for cardiovascular disease	1 year
number of antihypertensive medications	1 year
duration of hospitalization for all cause	1 year

Secondary Outcome Measures

Name	Time	Method
degree of overhydration	1 year
nutritional status	1 year
arterial pulse wave velocity	1 year
change in residual GFR	1 year
all-cause mortality	1 year
cardiovascular mortality	1 year

Trial Locations

Locations (1)

Prince of Wales Hospital; 🇭🇰 Shatin, Hong Kong