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The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dr Jennifer MacRae, University of Calgary
ClinicalTrials.gov Identifier:
NCT01466959
First received: October 11, 2011
Last updated: March 23, 2013
Last verified: March 2013
History of Changes
  Purpose

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.


Condition Intervention
Chronic Kidney Disease
 Other: citrate dialysate (CD)
Other: acetic-acid based dialysate (AD)

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: The Effect of Citrasate Dialysate on Heparin Dose: A Randomized Cross Over Trial in Hemodialysis Patients.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Calgary:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The change from baseline in the number of bleeding events, and bleeding time after HD. [ Time Frame: After 2 weeks of exposure to CD ] [ Designated as safety issue: Yes ]
  • 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 ] [ Designated as safety issue: No ]
  • The change in small and middle solute clearance from baseline. [ Time Frame: 2 weeks post exposure ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • The intra-rater and inter-rater reliability of our dialyzer / venous chamber clotting score. [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]

Enrollment: 20
Study Start Date: November 2011
Study Completion Date: January 2013
Primary Completion Date: January 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01466959

Locations
Canada, Alberta
University of Calgary
Calgary, Alberta, Canada, T2N 2T9
Sponsors and Collaborators
University of Calgary
Investigators
Study Director: Jennifer M MacRae, MD FRCPC University of Calgary
  More Information

No publications provided

Responsible Party: Dr Jennifer MacRae, Principal investigator, University of Calgary
ClinicalTrials.gov Identifier: NCT01466959     History of Changes
Other Study ID Numbers: ID24009
Study First Received: October 11, 2011
Last Updated: March 23, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by University of Calgary:
hemodialysis
dialysate
acetate based dialysate
 citrasate dialysate
heparin anticoagulation
hemodynamic stability

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Urologic Diseases
Renal Insufficiency
Retinol acetate
Citric Acid
Heparin
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
 Anticarcinogenic Agents
Protective Agents
Antineoplastic Agents
Therapeutic Uses
Anticoagulants
Hematologic Agents
Chelating Agents
Molecular Mechanisms of Pharmacological Action
Fibrinolytic Agents
Fibrin Modulating Agents
Cardiovascular Agents

ClinicalTrials.gov processed this record on May 19, 2013