Chronic Kidney Disease, Chronic Renal Disease
Conditions
Keywords
Hemodialysis, Dialysis, Renal
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.
Interventions
OTHERDialysis 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.
OTHERDialysis 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.
Sponsors
University of Louisville
Vanderbilt University Medical Center
University of California, Davis
Gambro Renal Products, Inc.
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min. | 4 weeks | 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
| Measure | Time frame | Description |
|---|---|---|
| Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min. | 4 weeks | 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 | 4 weeks | 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). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants All subjects who participated in the study. | 42 |
| Total | 42 |
Baseline characteristics
| Characteristic | All Study Participants |
|---|---|
| Age, Continuous >=18 years | 50 years |
| Pre-dialysis Weight | 84 kg |
| Sex: Female, Male Female | 16 Participants |
| Sex: Female, Male Male | 26 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 21 | 0 / 21 |
| serious Total, serious adverse events | 0 / 21 | 0 / 21 |
Outcome results
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).
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 600 mL/Min | Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min. | 1.66 single-pool Kt/Vurea (spKt/V) | Standard Deviation 0.25 |
| 800 mL/Min | Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min. | 1.63 single-pool Kt/Vurea (spKt/V) | Standard Deviation 0.21 |
Comparison: Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.95% CI: [-0.064, 0.024]ANOVA
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).
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 600 mL/Min | Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min. | 1.37 equilibrated Kt/Vurea (eKt/V) | Standard Deviation 0.2 |
| 800 mL/Min | Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min. | 1.35 equilibrated Kt/Vurea (eKt/V) | Standard Deviation 0.18 |
Comparison: Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.95% CI: [-0.051, 0.023]ANOVA
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).
Time frame: 4 weeks
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| 600 mL/Min | Kt/V Determined From Measurements of Ionic Dialysance | 1.46 Kt/VID | Standard Deviation 0.24 |
| 800 mL/Min | Kt/V Determined From Measurements of Ionic Dialysance | 1.49 Kt/VID | Standard Deviation 0.35 |
Comparison: Increasing the dialysate flow rates from 600 mL/min to 800 mL/min will not significantly increase Kt/Vurea.95% CI: [-0.029, 0.099]ANOVA