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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Kidney Disease; Chronic Renal Disease
• Intervention / Treatment: Other: Dialysis Flow Rate Start 600mL/min; Other: Dialysis Flow Rate Start 800mL/min

• Study Type: Interventional
• Enrollment (Actual): 42
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Sacramento, California, United States, 95817-1460
      • University of California Davis
  • Kentucky
    • Louisville, Kentucky, United States, 40202
      • University of Louisville
  • Tennessee
    • Nashville, Tennessee, United States, 37232-2372
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: 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.	Other: 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.
Other: 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.	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Baxter Healthcare Corporation
• Collaborators: University of California, Davis; Vanderbilt University Medical Center; University of Louisville; Gambro Renal Products, Inc.
• Investigators: Principal Investigator: Richard Ward, Ph.D., University of Louisville

Publications and helpful links

General Publications

• Daugirdas JT. Second generation logarithmic estimates of single-pool variable volume Kt/V: an analysis of error. J Am Soc Nephrol. 1993 Nov;4(5):1205-13. doi: 10.1681/ASN.V451205.
• Daugirdas JT, Schneditz D. Overestimation of hemodialysis dose depends on dialysis efficiency by regional blood flow but not by conventional two pool urea kinetic analysis. ASAIO J. 1995 Jul-Sep;41(3):M719-24. doi: 10.1097/00002480-199507000-00107.

Study record dates

Study Major Dates

• Study Start: September 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: August 18, 2009
• First Submitted That Met QC Criteria: August 18, 2009
• First Posted (Estimate): August 19, 2009

Study Record Updates

• Last Update Posted (Actual): May 10, 2017
• Last Update Submitted That Met QC Criteria: April 4, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Keywords: Hemodialysis; Dialysis, Renal
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Kidney Diseases; Renal Insufficiency, Chronic; Kidney Failure, Chronic
• Other Study ID Numbers: Gambro PI 2009