N/A
N=42
Study of How the Dose of Dialysis is Affected by Dialysate Flow Rate
Chronic Kidney Disease · Chronic Renal Disease
Bottom Line
View on ClinicalTrials.gov: NCT00962000 ↗Enrolled (actual)
42
Serious AEs
0.0%
Results posted
Jul 2011
Primary outcome: Primary: Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min. — 1.66; 1.63 single-pool Kt/Vurea (spKt/V)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Dialysis Flow Rate Start 600mL/min (Other); Dialysis Flow Rate Start 800mL/min (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vantive Health LLC
- Primary completion
- Jun 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Delivered Single-pool Kt/Vurea (spKt/V) at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min. |
1.66; 1.63 | — |
| SECONDARY Delivered Equilibrated Kt/Vurea (eKt/V at Dialysate Flow Rates of 600 mL/Min and 800 mL/Min. |
1.37; 1.35 | — |
| SECONDARY Kt/V Determined From Measurements of Ionic Dialysance |
1.46; 1.49 | — |
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
Data sourced from ClinicalTrials.gov (NCT00962000). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.