Clinical trial NCT02168283: Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients
Official title: Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Chronic Kidney Disease
Peritoneal Dialysis
Keywords: cardiovascular disease
hypertension
Lead sponsor: Chinese University of Hong Kong
Sponsor class: OTHER
First posted: 2014-06-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: blood pressure control
timeFrame: 1 year
measure: number of antihypertensive medications
timeFrame: 1 year
measure: duration of hospitalization for all cause
timeFrame: 1 year
measure: hospitalization for cardiovascular disease
timeFrame: 1 year
Secondary outcomes:
measure: degree of overhydration
timeFrame: 1 year
measure: change in residual GFR
timeFrame: 1 year
measure: nutritional status
timeFrame: 1 year
measure: arterial pulse wave velocity
timeFrame: 1 year
measure: cardiovascular mortality
timeFrame: 1 year
measure: all-cause mortality
timeFrame: 1 year
Other outcomes:
measure: cause of hospital admission
timeFrame: 1 year
Locations:
city: Shatin
country: Hong Kong
facility: Prince of Wales Hospital
Study officials:
References: