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

Chronic Kidney Disease Clinical Trial

Official title:

Effect of Dialysate Flow Rate on Delivered Dose of Dialysis (Kt/Vurea)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00962000
• Other study ID #: Gambro PI 2009
• Status: Completed
• Phase: N/A
• First received: August 18, 2009
• Last updated: March 27, 2015
• Start date: September 2009
• Est. completion date: June 2010

Study information

• Verified date: March 2015
• Source: Gambro Renal Products, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 42
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Chronic Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	University of Louisville	Louisville	Kentucky
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	University of California Davis	Sacramento	California

Sponsors (4)

Lead Sponsor	Collaborator
Gambro Renal Products, Inc.	University of California, Davis, University of Louisville, Vanderbilt University

Country where clinical trial is conducted

United States, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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).	4 weeks	No
Secondary	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).	4 weeks	No