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

Study Overview
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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.

Official Title
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Effect of Dialysate Flow Rate on Delivered Dose of Dialysis (Kt/Vurea)

Conditions
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Chronic Kidney Disease, Chronic Renal Disease

Intervention / Treatment
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* Other: Dialysis Flow Rate Start 600mL/min
* Other: Dialysis Flow Rate Start 800mL/min


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 600 mL/min<br>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. | Other: Dialysis Flow Rate Start 600mL/min<br>* 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.<br>|
| Other: 800 mL/min<br>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. | Other: Dialysis Flow Rate Start 800mL/min<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min. | The dose of dialysis delivered in a single treatment is commonly expressed in terms of Kt/Vurea, where K is the clearance of urea, t is the treatment time, and V is the urea distribution volume. When urea is removed from a single compartment during dialysis, it is called the single-pool Kt/V. Delivered Kt/Vurea was determined from pre-and post-dialysis BUN concentrations measured during the final treatment session of each group (ABAB or BABA). | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min. | The dose of dialysis delivered in a single treatment is commonly expressed in terms of Kt/Vurea, where K is the clearance of urea, t is the treatment time, and V is the urea distribution volume. The formula for equilibrated Kt/Vurea takes urea rebound into consideration. Delivered Kt/Vurea was determined from pre-and post-dialysis BUN concentrations measured during the final treatment session of each group (ABAB or BABA). | 4 weeks | 
| Kt/V Determined From Measurements of Ionic Dialysance | Kt/VID was determined for all study treatments at 2 of the 3 centers using on-line clearance measurements (Gambro Diascan or Fresenius On-line Clearance Monitor). | 4 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Hemodialysis, Dialysis, Renal