Clinical trial NCT01466959: The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis
Official title: The Effect of Citrasate Dialysate on Heparin Dose: A Randomized Cross Over Trial in Hemodialysis Patients.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Kidney Disease
Keywords: hemodialysis
dialysate
acetate based dialysate
citrasate dialysate
heparin anticoagulation
hemodynamic stability
Lead sponsor: University of Calgary
Sponsor class: OTHER
First posted: 2011-11-08
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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 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

Primary outcomes:
measure: The change from baseline in the cumulative dose of heparin anticoagulation used during conventional HD
timeFrame: 2 weeks after CD exposure, 2 weeks after AD exposure
Secondary outcomes:
measure: The change from baseline in the number of bleeding events, and bleeding time after HD.
timeFrame: After 2 weeks of exposure to CD
measure: The change from baseline in the number of intradialytic hypotension episodes and the change from baseline in the QT interval
timeFrame: 2 weeks after intervention exposure
measure: The change in small and middle solute clearance from baseline.
timeFrame: 2 weeks post exposure
measure: The change from baseline on laboratory inflammatory markers as well as ionized calcium (iCa), magnesium (Mg), and bicarbonate (HCO3).
timeFrame: 2 weeks post exposure
measure: The intra-rater and inter-rater reliability of our dialyzer / venous chamber clotting score.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Calgary
country: Canada
facility: University of Calgary
state: Alberta
Study officials:
affiliation: University of Calgary
name: Jennifer M MacRae, MD FRCPC
role: STUDY_DIRECTOR
References:
citation: Tai DJ, Leung K, Ravani P, Quinn RR, Scott-Douglas N, MacRae JM; Alberta Kidney Disease Network. The effect of citrate dialysate on intradialytic heparin dose in haemodialysis patients: study design of a randomised controlled trial. BMC Nephrol. 2015 Aug 25;16:147. doi: 10.1186/s12882-015-0144-z.