Study of How the Dose of Dialysis is Affected by Dialysate Flow Rate

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

42 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-09-30

Study Completion Date

2010-06-30

Brief Summary

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The purpose of this study is to look at how the dose of dialysis is affected by the rate at which dialysate flows through the dialyzer. The dose of dialysis (Kt/V) will be determined by measuring blood levels of urea at the beginning and end of dialysis at two different dialysate flow rates.

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Detailed Description

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Conditions

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Chronic Kidney Disease Chronic Renal Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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600 mL/min

Dialysis Flow Rate Start 600mL/min Subject starting dialysis flow rate set at 600mL/min. ABAB sequence where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.

Group Type OTHER

Dialysis Flow Rate Start 600mL/min

Intervention Type OTHER

ABAB sequence where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.

800 mL/min

Dialysis Flow Rate Start 800mL/min Subject starting dialysis flow rate set at 800mL/min. BABA sequence where B represents three consecutive treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min.

Group Type OTHER

Dialysis Flow Rate Start 800mL/min

Intervention Type OTHER

BABA sequence where B represents three consecutive treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min.

Interventions

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Dialysis Flow Rate Start 600mL/min

ABAB sequence where A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min and B represents three consecutive treatments with a dialysate flow rate of 800 mL/min.

Intervention Type OTHER

Dialysis Flow Rate Start 800mL/min

BABA sequence where B represents three consecutive treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive dialysis treatments with a dialysate flow rate of 600 mL/min.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Adult subject ≥18 years of age undergoing chronic hemodialysis for end- stage renal disease (ESRD) three times a week for at least three months with a stable treatment prescription
* Subject has no hospitalizations in previous three months for a significant illness related to a renal or dialysis problem except for vascular access surgery
* Subject with an AV fistula or graft capable of routinely delivering a blood flow rate of 400 mL/min

Exclusion Criteria

* Subject who is non-compliant with dialysis prescription
* Subject whose hemodialysis schedule is not three times a week
* Subject using a catheter for blood access
* Subject who is not anticoagulated with heparin during hemodialysis
* Subject with a current malignancy involving sites other than skin
* Subject with a history of drug or alcohol abuse within the last six months
* Subject who is believed to be unable to complete the entire study (e.g., due to a concurrent disease, life expectancy of less than a year, or scheduled kidney transplant
* Subject who is pregnant
* Subject who is considered incompetent to give an informed consent
* Subject with a positive test for hepatitis B surface antigen within the past 30 days (testing for hepatitis B surface antigen is not required for subjects who have tested positive for hepatitis B antibody within the past year and any such patients will not be subject to this exclusion criterion)
* Subject with known HIV infection (if this is not known, no HIV testing will be performed

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No