The Effect of Citrasate Dialysate on Heparin Dose in Hemodialysis

Not Applicable

Completed

• Conditions: Chronic Kidney Disease
• Interventions: Other: acetic-acid based dialysate (AD); Other: citrate dialysate (CD)

• Registration Number: NCT01466959
• Lead Sponsor: University of Calgary

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.

Study Timeline

• Study First Submitted: 2011-10-11
• Study Start: 2011-11
• Study First Submitted QC: 2011-11-07
• Study First Posted: 2011-11-08
• Primary Completion: 2013-01
• Study Completion: 2013-01
• Status Verified: 2013-03
• Last Update Submitted: 2013-03-23
• Last Update Posted: 2013-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
AD- acetic acid dialysate	acetic-acid based dialysate (AD)	AD is a standard bicarbonate based dialysate with a small amount of acetic acid which is the standard of care for dialysis.
CD - citrasate dialysate	citrate dialysate (CD)	Dialysis with a citric acid based dialyasate.

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
The change from baseline in the number of bleeding events, and bleeding time after HD.	After 2 weeks of exposure to CD
The intra-rater and inter-rater reliability of our dialyzer / venous chamber clotting score.	2 weeks
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

Trial Locations

Locations (1)

University of Calgary; 🇨🇦 Calgary, Alberta, Canada