Clinical trial NCT00962000: 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
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Chronic Renal Disease
Keywords: Hemodialysis
Dialysis, Renal
Lead sponsor: Vantive Health LLC
Sponsor class: INDUSTRY
Collaborators: name: University of Louisville
name: Vanderbilt University Medical Center
name: University of California, Davis
name: Gambro Renal Products, Inc.
name: Baxter Healthcare Corporation
First posted: 2009-08-19
Enrollment: 42
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.
timeFrame: 4 weeks
Secondary outcomes:
measure: Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min.
timeFrame: 4 weeks
measure: Kt/V Determined From Measurements of Ionic Dialysance
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Sacramento
country: United States
facility: University of California Davis
state: California
city: Louisville
country: United States
facility: University of Louisville
state: Kentucky
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: University of Louisville
name: Richard Ward, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.