Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| University of Calgary | OTHER |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to investigate the effectiveness of using two dialysers to lower the blood mineral levels in people receiving hemodialysis as compared to using one dialyser (usual treatment).
Higher levels of serum phosphate are independently associated with an increased risk of death in hemodialysis patients. Therefore, there has been considerable interest in controlling serum phosphate while minimizing oral calcium load. While most attention has focused on the use of non-calcium containing phosphate binders such as sevelamer and lanthanum, modifying conventional dialysis regimens to improve phosphate clearance is an alternative approach that remains relatively unstudied. A secondary analysis of a previous randomized cross-over study from our group found that the use of two dialysers in parallel resulted in a reduction in pre-dialysis serum phosphate levels. As this study was small, and the mechanisms resulting in the reduction in phosphate levels were unclear, further study is warranted. The investigators will conduct a randomized cross-over study comparing the impact of dialyzing using two dialysers in parallel with a single dialyser in hyperphosphatemic hemodialysis patients.
There will be a total of 34 participants from Alberta,Canada participating in this study. The length of study participation is 10 weeks.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Single dialyzer | Active Comparator | Single dialyzer |
|
| Double dialyzer | Experimental | Two dialyzers in parallel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Single dialyzer | Procedure | Hemodialysis treatment using a single Baxter dialyzer - considered standard hemodialysis treatment. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dialysate clearance of phosphate | Dialysate phosphate clearance levels in double dialyzer periods compared to single dialyzer periods. | 3 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Serum phosphate | Serum phosphate levels in the double dialyzer periods compared to the single dialyzer periods. | 3 weeks |
| Dialysate removal of phosphate | Dialysate removal levels of phosphate in the double dialyzer periods compared to the single dialyzer periods. |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants with serious adverse events | The proportion of participants during the double dialyzer period compared to the single dialyzer period experiencing serious adverse events resulting in death, life threatening illness, hospitalization or prolongation of existing hospitalization, or persistent or significant disability. | 30 days following last day of intervention |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Marcello Tonelli, MD | University of Alberta | Principal Investigator |
| Braden Manns, MD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 2T9 | Canada | ||
| University of Alberta |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27190374 | Result | Thompson S, Manns B, Lloyd A, Hemmelgarn B, MacRae J, Klarenbach S, Unsworth L, Courtney M, Tonelli M. Impact of using two dialyzers in parallel on phosphate clearance in hemodialysis patients: a randomized trial. Nephrol Dial Transplant. 2017 May 1;32(5):855-861. doi: 10.1093/ndt/gfw085. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D007676 | Kidney Failure, Chronic |
| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Two dialyzers | Procedure | Hemodialysis treatment using a two Baxter dialyzers in parallel. |
|
| 3 weeks |
| Proportion of participants with adverse events | The proportion of participants with adverse events (and by each type of adverse event) during the double dialyzer intervention compared to single dialyzer intervention. | 30 days following last day of intervention |
| Edmonton |
| Alberta |
| T6G 2V2 |
| Canada |
| D052776 |
| Female Urogenital Diseases |
| 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 |