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

Primary Purpose

Chronic Kidney Disease, Chronic Renal Disease

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Dialysis Flow Rate Start 600mL/min
Dialysis Flow Rate Start 800mL/min
Sponsored by
Baxter Healthcare Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Hemodialysis, Dialysis, Renal

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of California Davis
  • University of Louisville
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

600 mL/min

800 mL/min

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

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).
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).

Full Information

First Posted
August 18, 2009
Last Updated
April 4, 2017
Sponsor
Baxter Healthcare Corporation
Collaborators
University of Louisville, Vanderbilt University Medical Center, University of California, Davis, Gambro Renal Products, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00962000
Brief Title
Study of How the Dose of Dialysis is Affected by Dialysate Flow Rate
Official Title
Effect of Dialysate Flow Rate on Delivered Dose of Dialysis (Kt/Vurea)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
June 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Baxter Healthcare Corporation
Collaborators
University of Louisville, Vanderbilt University Medical Center, University of California, Davis, Gambro Renal Products, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Chronic Renal Disease
Keywords
Hemodialysis, Dialysis, Renal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
42 (Actual)

8. Arms, Groups, and Interventions

Arm Title
600 mL/min
Arm Type
Other
Arm Description
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.
Arm Title
800 mL/min
Arm Type
Other
Arm Description
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 Type
Other
Intervention Name(s)
Dialysis Flow Rate Start 600mL/min
Intervention Description
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 Type
Other
Intervention Name(s)
Dialysis Flow Rate Start 800mL/min
Intervention Description
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 Measure Information:
Title
Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.
Description
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).
Time Frame
4 weeks
Secondary Outcome Measure Information:
Title
Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.
Description
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).
Time Frame
4 weeks
Title
Kt/V Determined From Measurements of Ionic Dialysance
Description
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).
Time Frame
4 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard Ward, Ph.D.
Organizational Affiliation
University of Louisville
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California Davis
City
Sacramento
State/Province
California
ZIP/Postal Code
95817-1460
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232-2372
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
8305648
Citation
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.
Results Reference
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PubMed Identifier
8573901
Citation
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.
Results Reference
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Study of How the Dose of Dialysis is Affected by Dialysate Flow Rate

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