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

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ClinicalTrials.gov Identifier: NCT00962000
Recruitment Status : Completed
First Posted : August 19, 2009
Results First Posted : July 21, 2011
Last Update Posted : May 10, 2017
Sponsor:
Collaborators:
University of Louisville
Vanderbilt University Medical Center
University of California, Davis
Gambro Renal Products, Inc.
Information provided by (Responsible Party):
Baxter Healthcare Corporation

Tracking Information
First Submitted Date  ICMJE August 18, 2009
First Posted Date  ICMJE August 19, 2009
Results First Submitted Date  ICMJE June 22, 2011
Results First Posted Date  ICMJE July 21, 2011
Last Update Posted Date May 10, 2017
Study Start Date  ICMJE September 2009
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 22, 2011)
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).
Original Primary Outcome Measures  ICMJE
 (submitted: August 18, 2009)
The primary outcome is Kt/Vurea [ Time Frame: Pre- and post-dialysis BUN concentrations for each mid-week dialysis treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 22, 2011)
  • 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).
Original Secondary Outcome Measures  ICMJE
 (submitted: August 18, 2009)
Where possible, Kt/Vurea and clearance will be determined using on-line clearance measurements (Gambro Diascan or Fresenius On-line Clearance Monitor). [ Time Frame: Machine will be set to determine ionic dialysance at 30-minute intervals throughout the treatment. ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study of How the Dose of Dialysis is Affected by Dialysate Flow Rate
Official Title  ICMJE Effect of Dialysate Flow Rate on Delivered Dose of Dialysis (Kt/Vurea)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Chronic Kidney Disease
  • Chronic Renal Disease
Intervention  ICMJE
  • 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: 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.
Study Arms  ICMJE
  • 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.
    Intervention: Other: Dialysis Flow Rate Start 600mL/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.
    Intervention: Other: Dialysis Flow Rate Start 800mL/min
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 27, 2015)
42
Original Estimated Enrollment  ICMJE
 (submitted: August 18, 2009)
36
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date June 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00962000
Other Study ID Numbers  ICMJE Gambro PI 2009
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Baxter Healthcare Corporation
Study Sponsor  ICMJE Baxter Healthcare Corporation
Collaborators  ICMJE
  • University of Louisville
  • Vanderbilt University Medical Center
  • University of California, Davis
  • Gambro Renal Products, Inc.
Investigators  ICMJE
Principal Investigator: Richard Ward, Ph.D. University of Louisville
PRS Account Baxter Healthcare Corporation
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP