Examining the Impact of Using Two Dialysers in Parallel on Dialysis Adequacy in Hemodialysis Patients

End Stage Renal Disease Clinical Trial

Official title:

Examining the Impact of Using Two Dialysers in Parallel on Dialysis Adequacy in Hemodialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01539252
• Other study ID #: DDphos1
• Status: Completed
• Phase: N/A
• First received: February 3, 2012
• Last updated: December 7, 2016
• Start date: January 2013
• Est. completion date: December 2014

Study information

• Verified date: December 2016
• Source: University of Alberta
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

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).

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2014
• Est. primary completion date: November 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age > 18 years

• Patients must be on a stable regimen of hemodialysis for = 3 months ('stable' defined as not expected to require a change to the duration or frequency of treatments)

• Serum phosphate > 1.6 mmol/l on last two consecutive lab tests at least 3 weeks apart (KDOQI guidelines recommend maintaining predialysis phosphate < 1.8mmol/l - as such, phosphate lowering in this subgroup of patients is particularly relevant)

• Patients must be on stable doses of a phosphate binder with no changes in dose 1 month prior to study enrolment.

• Blood flow rate = 350 ml/min through a well-functioning access (This will exclude patients receiving inadequate dialysis due to a temporary venous dialysis catheter and will ensure sufficient blood flow to permit dialysis using two dialysers in parallel.)

Exclusion Criteria:

• Patients who have a scheduled renal transplant, change in dialysis modality, surgery or hospitalization or plan on moving away from the study site in the next three months.

• Patients with a projected life expectancy of less than 3 months.

• Patients with a contraindication to intra-dialytic anticoagulation. (Some patients require a small increase in the amount of anticoagulation required to prevent dialyser clotting when using two dialysers in parallel).

• Patients who have missed >8 dialysis treatments in the past 3 months.

• Patients with a dialysis regimen of >3 runs per week.

• Failure to provide informed consent.

• Patients enrolled in another (interventional) trial

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• End Stage Renal Disease
• Kidney Failure, Chronic

Intervention

Procedure:
• Single dialyzer
Hemodialysis treatment using a single Baxter dialyzer - considered standard hemodialysis treatment.
• Two dialyzers
Hemodialysis treatment using a two Baxter dialyzers in parallel.

Locations

Country	Name	City	State
Canada	University of Calgary	Calgary	Alberta
Canada	University of Alberta	Edmonton	Alberta

Sponsors (2)

Lead Sponsor	Collaborator
University of Alberta	University of Calgary

Country where clinical trial is conducted

Canada, 

References & Publications (1)

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. 2016 Apr 21. pii — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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	Yes
Other	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	Yes
Primary	Dialysate clearance of phosphate	Dialysate phosphate clearance levels in double dialyzer periods compared to single dialyzer periods.	3 weeks	No
Secondary	Serum phosphate	Serum phosphate levels in the double dialyzer periods compared to the single dialyzer periods.	3 weeks	No
Secondary	Dialysate removal of phosphate	Dialysate removal levels of phosphate in the double dialyzer periods compared to the single dialyzer periods.	3 weeks	No

External Links

•   Open access publication