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Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02168283
Recruitment Status : Withdrawn (Lack of funding)
First Posted : June 20, 2014
Last Update Posted : February 17, 2020
Sponsor:
Information provided by (Responsible Party):
Cheuk-Chun SZETO, 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.


Condition or disease Intervention/treatment Phase
Chronic Kidney Disease Peritoneal Dialysis Combination Product: treatment arm Behavioral: Control arm Phase 4

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Treatment of Asymptomatic Fluid Overload in Peritoneal Dialysis Patients
Study Start Date : December 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis

Arm Intervention/treatment
Experimental: treatment arm
active fluid management includes 3 components: dietary counseling, diuretics, and intensive dialysis regimen
Combination Product: treatment arm
Hypertonic peritoneal dialysis cycles

Behavioral: Control arm
Dietary counseling

Active Comparator: control arm
dietary counseling alone
Behavioral: Control arm
Dietary counseling




Primary Outcome Measures :
  1. blood pressure control [ Time Frame: 1 year ]
  2. number of antihypertensive medications [ Time Frame: 1 year ]
  3. duration of hospitalization for all cause [ Time Frame: 1 year ]
  4. hospitalization for cardiovascular disease [ Time Frame: 1 year ]

Secondary Outcome Measures :
  1. degree of overhydration [ Time Frame: 1 year ]
  2. change in residual GFR [ Time Frame: 1 year ]
  3. nutritional status [ Time Frame: 1 year ]
  4. arterial pulse wave velocity [ Time Frame: 1 year ]
  5. cardiovascular mortality [ Time Frame: 1 year ]
  6. all-cause mortality [ Time Frame: 1 year ]

Other Outcome Measures:
  1. cause of hospital admission [ Time Frame: 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 90 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02168283


Locations
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Hong Kong
Prince of Wales Hospital
Shatin, Hong Kong
Sponsors and Collaborators
Chinese University of Hong Kong
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Responsible Party: Cheuk-Chun SZETO, Professor, Chinese University of Hong Kong
ClinicalTrials.gov Identifier: NCT02168283    
Other Study ID Numbers: BPBCM
First Posted: June 20, 2014    Key Record Dates
Last Update Posted: February 17, 2020
Last Verified: February 2020
Keywords provided by Cheuk-Chun SZETO, Chinese University of Hong Kong:
cardiovascular disease
hypertension
Additional relevant MeSH terms:
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Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
Renal Insufficiency