The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Kidney Disease

Intervention / Treatment
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* Other: citrate dialysate (CD)
* Other: acetic-acid based dialysate (AD)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: AD- acetic acid dialysate<br>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)<br>* 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.<br>* Other names: Acetate dialysate;|
| Experimental: CD - citrasate dialysate<br>Dialysis with a citric acid based dialyasate. | Other: citrate dialysate (CD)<br>* 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.<br>* Other names: Citric acid dialysate;|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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hemodialysis, dialysate, acetate based dialysate, citrasate dialysate, heparin anticoagulation, hemodynamic stability