Examining the Impact of Using Two Dialysers in Parallel on Dialysis Adequacy in Hemodialysis Patients
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Examining the Impact of Using Two Dialysers in Parallel on Dialysis Adequacy in Hemodialysis Patients|
- Dialysate clearance of phosphate [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]Dialysate phosphate clearance levels in double dialyzer periods compared to single dialyzer periods.
- Serum phosphate [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]Serum phosphate levels in the double dialyzer periods compared to the single dialyzer periods.
- Dialysate removal of phosphate [ Time Frame: 3 weeks ] [ Designated as safety issue: No ]Dialysate removal levels of phosphate in the double dialyzer periods compared to the single dialyzer periods.
- Proportion of participants with serious adverse events [ Time Frame: 30 days following last day of intervention ] [ Designated as safety issue: Yes ]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.
- Proportion of participants with adverse events [ Time Frame: 30 days following last day of intervention ] [ Designated as safety issue: Yes ]The proportion of participants with adverse events (and by each type of adverse event) during the double dialyzer intervention compared to single dialyzer intervention.
|Study Start Date:||January 2013|
|Study Completion Date:||December 2014|
|Primary Completion Date:||November 2014 (Final data collection date for primary outcome measure)|
Active Comparator: Single dialyzer
Procedure: Single dialyzer
Hemodialysis treatment using a single Baxter dialyzer - considered standard hemodialysis treatment.
Experimental: Double dialyzer
Two dialyzers in parallel
Procedure: Two dialyzers
Hemodialysis treatment using a two Baxter dialyzers in parallel.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01539252
|University of Calgary|
|Calgary, Alberta, Canada, T2N 2T9|
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2V2|
|Principal Investigator:||Marcello Tonelli, MD||University of Alberta|
|Principal Investigator:||Braden Manns, MD||University of Calgary|