Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients

NCT02168283 | Withdrawn Phase 4

• 1 other identifier: BPBCM
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease; Peritoneal Dialysis

Keywords

cardiovascular disease; hypertension

Outcome Measures

Primary Outcomes (4)

• 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 Outcomes (6)

• 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

Other Outcomes (1)

• cause of hospital admission

  1 year

Study Arms (2)

treatment arm

EXPERIMENTAL

active fluid management includes 3 components: dietary counseling, diuretics, and intensive dialysis regimen

Combination Product: treatment arm; Behavioral: Control arm

control arm

ACTIVE COMPARATOR

dietary counseling alone

Behavioral: Control arm

Interventions

treatment arm COMBINATION_PRODUCT

Hypertonic peritoneal dialysis cycles

treatment arm

Control arm BEHAVIORAL

Dietary counseling

control arm; treatment arm

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Study Sites (1)

Prince of Wales Hospital

Shatin, Hong Kong

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Cardiovascular Diseases; Hypertension

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Vascular Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 18, 2014
• First Posted: June 20, 2014
• Study Start: December 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2018
• Last Updated: February 17, 2020

Record last verified: 2020-02

Locations

HK (1)