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| Name | Class |
|---|---|
| University of Louisville | OTHER |
| Vanderbilt University Medical Center | OTHER |
| University of California, Davis | OTHER |
| Gambro Renal Products, Inc. |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 600 mL/min | Other | 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. |
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| 800 mL/min | Other | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dialysis Flow Rate Start 600mL/min | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Ward, Ph.D. | University of Louisville | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California Davis | Sacramento | California | 95817-1460 | United States | ||
| University of Louisville |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 8305648 | Background | 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. | |
| 8573901 | Background | 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. |
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| ID | Title | Description |
|---|---|---|
| FG000 | 600 mL/Min First | Subject starting dialysis flow rate set at 600mL/min. Following an ABAB study design 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. |
| FG001 | 800 mL/Min First | Subject starting dialysis flow rate set at 800mL/min. Following an BABA study design where B represents three consecutive dialysis treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive treatments with a dialysate flow rate of 600 mL/min. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Period 1 - 1 Week |
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| Period 2 - 1 Week |
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| Period 3 - 1 Week |
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| Period 4 - 1 Week |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All subjects who participated in the study. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | Standard Deviation | single-pool Kt/Vurea (spKt/V) | 4 weeks | Treatments | Treatments |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 600 mL/Min First | Subject starting dialysis flow rate set at 600mL/min. Following an ABAB study design 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Global CORP Clinical Trials Disclosure | Vantive | +1 2249484283 | Global.CORP.ClinicalTrialsDisclosure@vantive.com |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| INDUSTRY |
| Baxter Healthcare Corporation | INDUSTRY |
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| Dialysis Flow Rate Start 800mL/min | Other | 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. |
|
| 4 weeks |
| 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 |
| Louisville |
| Kentucky |
| 40202 |
| United States |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37232-2372 | United States |
| NOT COMPLETED |
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| NOT COMPLETED |
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| NOT COMPLETED |
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| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Pre-dialysis Weight | Mean | Full Range | kg |
|
Dialysate flow rate of 800 mL/min
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| 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). | Posted | Mean | Standard Deviation | equilibrated Kt/Vurea (eKt/V) | 4 weeks | Treatments | Treatments |
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|
|
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| 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). | Posted | Mean | Standard Deviation | Kt/VID | 4 weeks | Treatments | Treatments |
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|
|
|
| 0 |
| 21 |
| 0 |
| 21 |
| EG001 | 800 mL/Min First | Subject starting dialysis flow rate set at 800mL/min. Following an BABA study design where B represents three consecutive dialysis treatments with a dialysate flow rate of 800 mL/min and A represents three consecutive treatments with a dialysate flow rate of 600 mL/min. | 0 | 21 | 0 | 21 |
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| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
The sample size required for the study was estimated using a web-based power calculation tool. Analysis of data from some 50,000 hemodialysis patients showed a within-patient between-treatment standard deviation of 0.21 for Kt/Vurea. Using this estimate of standard deviation, 38 subjects would be needed to detect a difference in Kt/Vurea of 0.1 with a significance level of 0.05 and a power of 90% with two determinations per subject at each level of dialysate flow rate. |