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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Alberta
Sponsor:
Collaborator:
University of Calgary
Information provided by (Responsible Party):
Marcello Tonelli, University of Alberta
ClinicalTrials.gov Identifier:
NCT01539252
First received: February 3, 2012
Last updated: July 8, 2013
Last verified: July 2013
  Purpose

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).


Condition Intervention
End Stage Renal Disease
Procedure: Single dialyzer
Procedure: Two dialyzers

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Alberta:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Other Outcome Measures:
  • 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.


Estimated Enrollment: 34
Study Start Date: January 2013
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: November 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Single dialyzer
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01539252

Contacts
Contact: Susan Szigety 780 407-7868 sszigety@ualberta.ca

Locations
Canada, Alberta
University of Calgary Not yet recruiting
Calgary, Alberta, Canada, T2N 2T9
Contact: Sharon Gulewich    403 944 9878    Sharon.Gulewich@albertahealthservices.ca   
Contact: Natasha Wiebe, MMath PStat    780 407 1532    nwiebe@ualberta.ca   
Principal Investigator: Braden Manns, MD MSc         
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2V2
Contact: Sue Szigety, MSc    780 407 7868    szigety@ualberta.ca   
Contact: Natasha Wiebe, MMath PStat    780 407 1532    nwiebe@ualberta.ca   
Sub-Investigator: Stephanie Thompson, MD         
Principal Investigator: Marcello Tonelli, MD SM         
Sponsors and Collaborators
University of Alberta
University of Calgary
Investigators
Principal Investigator: Marcello Tonelli, MD University of Alberta
Principal Investigator: Braden Manns, MD University of Calgary
  More Information

No publications provided

Responsible Party: Marcello Tonelli, Principal Investigator, University of Alberta
ClinicalTrials.gov Identifier: NCT01539252     History of Changes
Other Study ID Numbers: DDphos1
Study First Received: February 3, 2012
Last Updated: July 8, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Alberta:
hemodialysis
adequacy
phosphate clearance
double dialyzer
two dialyzers in parallel

Additional relevant MeSH terms:
Kidney Diseases
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on September 22, 2014