NCT03887468已完成不适用
Dialysis Adequacy and Clotting Complications During Anticoagulation-free Hemodialysis Using a Heparin-grafted Dialyzer and a Citrate-enriched Dialysate: a Prospective Randomized Crossover Study. (EvoCit-HD Study)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 38
- 试验地点
- 4
- 主要终点
- change in dialysis adequacy
研究概览
简要总结
After providing informed consent, patients will be randomized to either the intervention treatment ("EvoCit procedure") or the control treatment ("EvoHep procedure").
After randomization, each study arm consists of four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol. After the last dialysis treatment of the fourth treatment week and after a long interdialytic interval, patients will crossover to the alternative hemodialysis procedure. After crossover, the study will be completed with, again, four weeks of 3x4 hours hemodialysis treatments according to the allocated protocol.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients treated with hemodialysis or hemodiafiltration since at least three months.
- •Hemodialysis or hemodiafiltration prescription of 3 x 4 hours weekly.
- •≥ 18 years of age.
- •Patients able and agree to provide signed informed consent.
排除标准
- •Contraindication to heparin defined as known heparin-induced thrombopenia or active bleeding risk with contra-indication for systemic anticoagulation, categorized as defined by Swartz and Port
- •Planned surgery during study period, including scheduled living-donor kidney transplantation during study period.
- •Hypercoagulable state defined as known malignancy, known APC resistance/FV Leiden, known prothrombin gene mutation, known protein C or protein S deficiency, known antithrombin deficiency.
- •Mean Qb of <300ml/min during one of the last 3 dialysis sessions before inclusion.
- •1 or more results of spKt/Vurea < 1,35 during the last three months prior to study inclusion.
- •Need for 2 or more supplementary dialysis sessions on top of the regular 3x4 hours weekly hemodialysis regimen during the last month before inclusion.
- •Vascular access dysfunction defined as
- •use of urokinase the 2 months before study inclusion, including to restore catheter permeability.
- •non-tunneled hemodialysis catheter use.
- •known AV access outflow tract stenosis.
- •planned vascular access intervention.
- •planned vascular access conversion.
- •Known allergy against heparin grafted AN69STmembranes.
- •Use of ACE-inhibitor
- •Use of vitamin K antagonist
- •Use of novel oral anticoagulant therapy.
- •Any medical condition, which puts the patient at risk of premature study termination in the opinion of the investigator.
- •Planned conversion of dialysis modality during study period or planned absence/leave (including pregnancy or planned pregnancy).
- •Symptomatic hypocalcemia.
- •Hb < 8g/dl at screening.
- •Hct > 45% at screening.
- •Perdialytic total parenteral nutrition therapy
结局指标
主要结局
change in dialysis adequacy
时间窗: every midweek dialysis session through study duration, ie 2x4 weeks
spKt/Vurea
次要结局
- change in dialysis adequacy expressed by middle molecule (MM) clearance(every 1st and 4th week HD session through study duration, ie 2x4 weeks)
- occurence of biological evaluation of coagulation activation(every 1st and 4th week HD session through study duration, ie 2x4 weeks)
- proportion of thrombotic dysfunction(every HD session through study duration, ie 2x4 weeks)
- occurence of complete circuit thrombosis(every HD session through study duration, ie 2x4 weeks)
- change in membrane coagulation(every midweek HD session through study duration, ie 2x4 weeks)
研究者
研究点 (4)
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