Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients

Chronic Kidney Disease Clinical Trial

Official title:

Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02168283
• Other study ID #: BPBCM
• Status: Withdrawn
• Phase: Phase 4
• Start date: December 2015
• Est. completion date: September 2018

Study information

• Verified date: February 2020
• Source: Chinese University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Peritoneal Dialysis
• Renal Insufficiency, Chronic

Intervention

Combination Product:
• treatment arm
Hypertonic peritoneal dialysis cycles

Behavioral:
• Control arm
Dietary counseling

Locations

Country	Name	City	State
Hong Kong	Prince of Wales Hospital	Shatin

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Country where clinical trial is conducted

Hong Kong, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	cause of hospital admission		1 year
Primary	blood pressure control		1 year
Primary	number of antihypertensive medications		1 year
Primary	duration of hospitalization for all cause		1 year
Primary	hospitalization for cardiovascular disease		1 year
Secondary	degree of overhydration		1 year
Secondary	change in residual GFR		1 year
Secondary	nutritional status		1 year
Secondary	arterial pulse wave velocity		1 year
Secondary	cardiovascular mortality		1 year
Secondary	all-cause mortality		1 year