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Completed

NCT Number: NCT01539252

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

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).

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Calgary, Calgary, Alberta, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Single dialyzer

Procedure

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

Two dialyzers

Procedure

Hemodialysis treatment using a two Baxter dialyzers in parallel.

Primary outcomes

  1. Dialysate clearance of phosphate

    Time frame: 3 weeks

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

Secondary outcomes

  1. Serum phosphate

    Time frame: 3 weeks

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

  2. Dialysate removal of phosphate

    Time frame: 3 weeks

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

Other outcomes

  1. Proportion of participants with serious adverse events

    Time frame: 30 days following last day of intervention

    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.

  2. Proportion of participants with adverse events

    Time frame: 30 days following last day of intervention

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

Sponsors and collaborators

Lead sponsor

University of Alberta

Other

Collaborators

  • University of Calgary

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Feb 27, 2012
Registry last updated
Dec 8, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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