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

NCT ID: NCT01539252

Last Updated: 2016-12-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 33 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-01-31
• Study Completion Date: 2014-12-31

Brief 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).

Detailed 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.

Conditions

End Stage Renal Disease

Keywords

hemodialysis; adequacy; phosphate clearance; double dialyzer; two dialyzers in parallel

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Single dialyzer

Single dialyzer

Group Type: ACTIVE_COMPARATOR

Single dialyzer

Intervention Type: PROCEDURE

Hemodialysis treatment using a single Baxter dialyzer - considered standard hemodialysis treatment.

Double dialyzer

Two dialyzers in parallel

Group Type: EXPERIMENTAL

Two dialyzers

Intervention Type: PROCEDURE

Hemodialysis treatment using a two Baxter dialyzers in parallel.

Interventions

Single dialyzer

Hemodialysis treatment using a single Baxter dialyzer - considered standard hemodialysis treatment.

Intervention Type: PROCEDURE

Two dialyzers

Hemodialysis treatment using a two Baxter dialyzers in parallel.

Intervention Type: PROCEDURE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Calgary

OTHER

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Responsible Party

Marcello Tonelli

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcello Tonelli, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Braden Manns, MD

Role: PRINCIPAL_INVESTIGATOR

University of Calgary

Locations

University of Calgary

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Countries

Canada

References

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.

Reference Type: RESULT

PMID: 27190374 (View on PubMed)

Other Identifiers

DDphos1

Identifier Type: -

Identifier Source: org_study_id