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NCT Number: NCT00962000

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

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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Key information

Conditions

Chronic Kidney Disease Chronic Disease Chronic Renal Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California Davis, Sacramento, California, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Dialysis Flow Rate Start 600mL/min

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.

Dialysis Flow Rate Start 800mL/min

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.

Primary outcomes

  1. Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.

    Time frame: 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 outcomes

  1. Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.

    Time frame: 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).

  2. Kt/V Determined From Measurements of Ionic Dialysance

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Vantive Health LLC

Industry

Collaborators

  • Baxter Healthcare Corporation
  • Gambro Renal Products, Inc.
  • University of California, Davis
  • University of Louisville
  • Vanderbilt University Medical Center

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Aug 19, 2009
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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