Abstract
BackgroundUnfractionated heparin is the most common anticoagulant used in haemodialysis (HD), although it has many potential adverse effects. Citrate dialysate (CD) has an anticoagulant effect which may allow reduction in cumulative heparin dose (CHD) compared to standard acetate dialysate (AD).MethodsThis double-blinded, randomised, cross-over trial of chronic haemodialysis patients determines if CD allows reduction in CHD during HD compared with AD. After enrolment, intradialytic heparin is minimised during a two-week run-in period using a standardised protocol based on a visual clotting score. Patients still requiring intradialytic heparin after the run-in period are randomised to two weeks of HD with AD followed by two weeks of CD (Sequence 1) or two weeks of HD with CD followed by two weeks of AD (Sequence 2). The primary outcome is the change in CHD with CD compared with AD. Secondary outcomes include metabolic and haemodynamic parameters, and dialysis adequacy.DiscussionThis randomised controlled trial will determine the impact of CD compared with AD on CHD during HD.Trial registrationClinicalTrials.gov NCT01466959
Highlights
Unfractionated heparin is the most common anticoagulant used in haemodialysis (HD), it has many potential adverse effects
We describe our protocol for a six-week, doubleblinded, randomised cross-over trial that investigates whether Citrate dialysate (CD) results in reduced cumulative heparin dose (CHD) compared to acetate dialysate (AD) in chronic HD patients
The main limitation of this study is that the two groups were not treated ; unlike the CD group, no attempt was made to reduce anticoagulation in the AD group [29]
Summary
Study setting This randomised crossover clinical trial is performed within three community HD units in Calgary, Alberta, Canada, where unfractionated heparin is used for standard intradialytic anticoagulation. Patients begin each study phase (AD and CD) with their baseline intradialytic heparin dose, determined at the end of the run-in period. To ensure consistency, scoring of dialyser/venous chamber clotting for heparin dose adjustments are performed at the end of each HD session by a single, trained research nurse. Using the ultrasound dilution technique (Transonic® HD02 monitor, Transonic Systems Inc.®, Ithaca, NY, USA), dialyser FBV is measured twice (and the mean recorded) during both the first and last 30 min of the mid-week HD sessions throughout the entire study period (including the run-in phase). If there is no evidence of period or carry-over effects, all comparisons will be presented relative to AD, without the need for consideration of carry-over effects
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