The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis

University of Calgary

Status: Completed

Conditions: Chronic Kidney Disease

Treatments: Other: acetic-acid based dialysate (AD); Other: citrate dialysate (CD)

Study type: Interventional

Funder types: Other

Identifiers

NCT01466959

ID24009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 20 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Quadruple Blind

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20 participants in 2 patient groups

AD- acetic acid dialysate

Active Comparator group

Description:

AD is a standard bicarbonate based dialysate with a small amount of acetic acid which is the standard of care for dialysis.

Treatment:

Other: acetic-acid based dialysate (AD)

CD - citrasate dialysate

Experimental group

Description:

Dialysis with a citric acid based dialyasate.

Treatment:

Other: citrate dialysate (CD)