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

October 11, 2011
March 23, 2013
November 2011
January 2013   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01466959 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis
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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Chronic Kidney Disease
  • 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
  • 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
  • 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.
    Intervention: Other: acetic-acid based dialysate (AD)
  • Experimental: CD - citrasate dialysate
    Dialysis with a citric acid based dialyasate.
    Intervention: Other: citrate dialysate (CD)
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
January 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01466959
ID24009
Yes
Dr Jennifer MacRae, University of Calgary
University of Calgary
Not Provided
Study Director: Jennifer M MacRae, MD FRCPC University of Calgary
University of Calgary
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP