Try our beta test site

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

This study has been completed.
Sponsor:
Collaborators:
University of Louisville
Vanderbilt University
University of California, Davis
Information provided by (Responsible Party):
Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier:
NCT00962000
First received: August 18, 2009
Last updated: March 27, 2015
Last verified: March 2015
  Purpose
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.

Condition Intervention
Chronic Kidney Disease
Chronic Renal Disease
Other: Dialysis Flow Rate Start 600mL/min
Other: Dialysis Flow Rate Start 800mL/min

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effect of Dialysate Flow Rate on Delivered Dose of Dialysis (Kt/Vurea)

Further study details as provided by Gambro Renal Products, Inc.:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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).

  • 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).


Enrollment: 42
Study Start Date: September 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00962000

Locations
United States, California
University of California Davis
Sacramento, California, United States, 95817-1460
United States, Kentucky
University of Louisville
Louisville, Kentucky, United States, 40202
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232-2372
Sponsors and Collaborators
Gambro Renal Products, Inc.
University of Louisville
Vanderbilt University
University of California, Davis
Investigators
Principal Investigator: Richard Ward, Ph.D. University of Louisville
  More Information

Publications:
Responsible Party: Gambro Renal Products, Inc.
ClinicalTrials.gov Identifier: NCT00962000     History of Changes
Other Study ID Numbers: Gambro PI 2009 
Study First Received: August 18, 2009
Results First Received: June 22, 2011
Last Updated: March 27, 2015

Keywords provided by Gambro Renal Products, Inc.:
Hemodialysis
Dialysis, Renal

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Dialysis Solutions
Pharmaceutical Solutions

ClinicalTrials.gov processed this record on February 20, 2017