The Effect of Citrasate Dialysate on Heparin Dose: A Randomized Cross Over Trial in Hemodialysis Patients.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- The change from baseline in the cumulative dose of heparin anticoagulation used during conventional HD
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •chronic stable HD patients ≥ 18 years
- •on HD at least three times per week for at least 3 months
排除标准
- •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
结局指标
主要结局
The change from baseline in the cumulative dose of heparin anticoagulation used during conventional HD
时间窗: 2 weeks after CD exposure, 2 weeks after AD exposure
次要结局
- 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)
研究者
Dr Jennifer MacRae
Principal investigator
University of Calgary