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)
1 other identifier
interventional
42
1 country
3
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Sep 2009
Shorter than P25 for not_applicable
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 18, 2009
CompletedFirst Posted
Study publicly available on registry
August 19, 2009
CompletedStudy Start
First participant enrolled
September 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
July 21, 2011
CompletedJuly 24, 2025
July 1, 2025
9 months
August 18, 2009
June 22, 2011
July 3, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.
4 weeks
Kt/V Determined From Measurements of Ionic Dialysance
4 weeks
Study Arms (2)
600 mL/min
OTHERDialysis 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.
800 mL/min
OTHERDialysis 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.
Interventions
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.
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 Criteria
You may qualify if:
- 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
You may not qualify if:
- 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 known HIV infection (if this is not known, no HIV testing will be performed
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Vantive Health LLClead
- University of Louisvillecollaborator
- Vanderbilt University Medical Centercollaborator
- University of California, Daviscollaborator
- Gambro Renal Products, Inc.collaborator
- Baxter Healthcare Corporationcollaborator
Study Sites (3)
University of California Davis
Sacramento, California, 95817-1460, United States
University of Louisville
Louisville, Kentucky, 40202, United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232-2372, United States
Related Publications (2)
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.
PMID: 8305648BACKGROUNDDaugirdas 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.
PMID: 8573901BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Global CORP Clinical Trials Disclosure
- Organization
- Vantive
Study Officials
- PRINCIPAL INVESTIGATOR
Richard Ward, Ph.D.
University of Louisville
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- GT60
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- CROSSOVER
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 18, 2009
First Posted
August 19, 2009
Study Start
September 1, 2009
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
July 24, 2025
Results First Posted
July 21, 2011
Record last verified: 2025-07