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

Vantive Health LLC

Status: Completed

Conditions: Chronic Kidney Disease; Chronic Renal Disease

Treatments: Other: Dialysis Flow Rate Start 600mL/min; Other: Dialysis Flow Rate Start 800mL/min

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00962000

Gambro PI 2009

Details and patient eligibility

About

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.

Enrollment: 42 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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42 participants in 2 patient groups

600 mL/min

Other group

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.

Treatment:

Other: Dialysis Flow Rate Start 600mL/min

800 mL/min

Other group

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.

Treatment:

Other: Dialysis Flow Rate Start 800mL/min