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

Not Applicable

Completed

Interventions: Other: Dialysis Flow Rate Start 600mL/min
Other: Dialysis Flow Rate Start 800mL/min

Brief Summary: 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.

Recruitment & Eligibility

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

Arm && Interventions

Group	Intervention	Description
600 mL/min	Dialysis Flow Rate Start 600mL/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.
800 mL/min	Dialysis Flow Rate Start 800mL/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.

Primary Outcome Measures

Name	Time	Method
Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.	4 weeks	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).

Secondary Outcome Measures

Name	Time	Method
Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.	4 weeks	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).
Kt/V Determined From Measurements of Ionic Dialysance	4 weeks	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).

Locations (3): University of California Davis
🇺🇸
Sacramento, California, United States
University of Louisville
🇺🇸
Louisville, Kentucky, United States
Vanderbilt University Medical Center
🇺🇸
Nashville, Tennessee, United States