The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis

March 23, 2013 updated by: Dr Jennifer MacRae, University of Calgary

The Effect of Citrasate Dialysate on Heparin Dose: A Randomized Cross Over Trial in Hemodialysis Patients.

An alternative to systemic heparin anticoagulation for HD is citrate dialysate (CD). CD contains a small amount of citric acid rather than acetic acid as the acidifying agent. The use of citrasate may lead to lower heparin requirements in hemodialysis. This is a randomized, double blinded, two-period crossover trial in HD patients to compare the effect of citrasate dialysis (CD) and usual acetic-acid based dialysate (AD) on heparin dose.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The investigators will perform a randomized, double-blind, two-period crossover trial in chronic HD patients to compare the effect of citrasate dialysate (CD) and usual acetic-acid based dialysate (AD) on the cumulative intradialytic heparin dose. There is a four week run in phase followed by two weeks of intervention AD or CD followed by the remaining AD or CD intervention.

The primary outcome is change in intradialytic heparin dose achieved with citrasate compared with acetate dialysate. Secondary outcomes are the effect of CD compared with AD on systemic anticoagulation, bleeding time after HD, metabolic parameters, dialysis adequacy, inflammation, hemodynamic stability, and intra-rater and inter-rater reliability of the dialyzer clotting score.

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2N 2T9
        • University Of Calgary

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • chronic stable HD patients ≥ 18 years
  • on HD at least three times per week for at least 3 months

Exclusion Criteria:

  • contraindication to heparin
  • currently using heparin-free HD
  • known clotting disorder
  • on warfarin therapy
  • dialyzing with a dysfunctional central venous catheter (blood flow rates consistently less than 300mL/min and/or frequent use of thrombolytic)
  • history of vascular access dysfunction
  • planned vascular access conversion or procedure during the study period
  • use of high calcium dialysate
  • active medical issue requiring hospitalization
  • planned kidney transplant during the study period
  • planned conversion of dialysis modality (peritoneal dialysis, nocturnal dialysis) during the study period
  • unable to provide informed consent

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: AD- acetic acid dialysate
AD is a standard bicarbonate based dialysate with a small amount of acetic acid which is the standard of care for dialysis.
Other: acetic-acid based dialysate (AD)
Acetate based dialysate; AD is the standard dialysate used in hemodialysis runs 4 hours three times weekly. For the study it will be used for a period of 2 weeks and compared to the CD study time period.
Other Names:
  • Acetic acid dialysate
  • Acetate dialysate
Experimental: CD - citrasate dialysate
Dialysis with a citric acid based dialyasate.
Other: citrate dialysate (CD)
Citrasate (CD) is substituted as the dialysate during the patients regular dialysis run 4hours three times weekly for a period of 2 weeks. The only difference between citrasate and the regular dialysate is the lack of acetic acid.
Other Names:
  • Citrasate
  • Citric acid dialysate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
The change from baseline in the cumulative dose of heparin anticoagulation used during conventional HD
Time Frame: 2 weeks after CD exposure, 2 weeks after AD exposure
2 weeks after CD exposure, 2 weeks after AD exposure

Secondary Outcome Measures

Outcome Measure
Time Frame
The change from baseline in the number of bleeding events, and bleeding time after HD.
Time Frame: After 2 weeks of exposure to CD
After 2 weeks of exposure to CD
The change from baseline in the number of intradialytic hypotension episodes and the change from baseline in the QT interval
Time Frame: 2 weeks after intervention exposure
2 weeks after intervention exposure
The change in small and middle solute clearance from baseline.
Time Frame: 2 weeks post exposure
2 weeks post exposure
The change from baseline on laboratory inflammatory markers as well as ionized calcium (iCa), magnesium (Mg), and bicarbonate (HCO3).
Time Frame: 2 weeks post exposure
2 weeks post exposure
The intra-rater and inter-rater reliability of our dialyzer / venous chamber clotting score.
Time Frame: 2 weeks
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Calgary

Investigators

  • Study Director: Jennifer M MacRae, MD FRCPC, University Of Calgary

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2011

Primary Completion (Actual)

January 1, 2013

Study Completion (Actual)

January 1, 2013

Study Registration Dates

First Submitted

October 11, 2011

First Submitted That Met QC Criteria

November 7, 2011

First Posted (Estimate)

November 8, 2011

Study Record Updates

Last Update Posted (Estimate)

March 26, 2013

Last Update Submitted That Met QC Criteria

March 23, 2013

Last Verified

March 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ID24009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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