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

Primary Purpose

End Stage Renal Disease

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Single dialyzer

Two dialyzers

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring hemodialysis, adequacy, phosphate clearance, double dialyzer, two dialyzers in parallel

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

University of Calgary
University of Alberta

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Single dialyzer

Double dialyzer

Arm Description

Single dialyzer

Two dialyzers in parallel

Outcomes

Primary Outcome Measures

Dialysate clearance of phosphate

Dialysate phosphate clearance levels in double dialyzer periods compared to single dialyzer periods.

Secondary Outcome Measures

Serum phosphate

Serum phosphate levels in the double dialyzer periods compared to the single dialyzer periods.

Dialysate removal of phosphate

Dialysate removal levels of phosphate in the double dialyzer periods compared to the single dialyzer periods.

Full Information

NCT ID

NCT01539252

First Posted

February 3, 2012

Last Updated

December 7, 2016

Sponsor

University of Alberta

Collaborators

University of Calgary

1. Study Identification

Unique Protocol Identification Number

NCT01539252

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2016

Overall Recruitment Status

Completed

Study Start Date

January 2013 (undefined)

Primary Completion Date

November 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

University of Alberta

Collaborators

University of Calgary

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease

Keywords

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

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Single dialyzer

Arm Type

Active Comparator

Arm Description

Single dialyzer

Arm Title

Double dialyzer

Arm Type

Experimental

Arm Description

Two dialyzers in parallel

Intervention Type

Procedure

Intervention Name(s)

Single dialyzer

Intervention Description

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

Intervention Type

Procedure

Intervention Name(s)

Two dialyzers

Intervention Description

Hemodialysis treatment using a two Baxter dialyzers in parallel.

Primary Outcome Measure Information:

Title

Dialysate clearance of phosphate

Description

Dialysate phosphate clearance levels in double dialyzer periods compared to single dialyzer periods.

Time Frame

3 weeks

Secondary Outcome Measure Information:

Title

Serum phosphate

Description

Serum phosphate levels in the double dialyzer periods compared to the single dialyzer periods.

Time Frame

3 weeks

Title

Dialysate removal of phosphate

Description

Dialysate removal levels of phosphate in the double dialyzer periods compared to the single dialyzer periods.

Time Frame

3 weeks

Other Pre-specified Outcome Measures:

Title

Proportion of participants with serious adverse events

Description

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.

Time Frame

30 days following last day of intervention

Title

Proportion of participants with adverse events

Description

The proportion of participants with adverse events (and by each type of adverse event) during the double dialyzer intervention compared to single dialyzer intervention.

Time Frame

30 days following last day of intervention

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marcello Tonelli, MD

Organizational Affiliation

University of Alberta

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Braden Manns, MD

Organizational Affiliation

University of Calgary

Official's Role

Principal Investigator

Facility Information:

Facility Name

University of Calgary

City

Calgary

State/Province

Alberta

ZIP/Postal Code

T2N 2T9

Country

Canada

Facility Name

University of Alberta

City

Edmonton

State/Province

Alberta

ZIP/Postal Code

T6G 2V2

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

27190374

Citation

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.

Results Reference

result

Links:

URL

http://ndt.oxfordjournals.org/content/early/2016/04/21/ndt.gfw085.long

Description

Open access publication

Learn more about this trial

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

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