跳至主要内容
临床试验/NCT03470727
NCT03470727已完成不适用

The Effect of Citrate Dialysate on Clot Formation and Anemia in Hemodialysis Patients

Bangkok Metropolitan Administration Medical College and Vajira Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2017年9月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
60
试验地点
2
主要终点
Effect of citrate dialysate to anemia

研究概览

简要总结

Acetate-free citrate containing dialysate is expected to be clinically effective in maintaining hemodynamic stability during hemodialysis (HD). It has been demonstrated that citrate dialysate help produce a local anticoagulant effect by chelating ionized calcium. Moreover, citrate can improve phosphate and beta2 macroglobulin and better control of arterial hypertension and hemoglobinemia. We therefore would like to study the effect of citrate dialysate on clot formation and anemia while reducing heparin in chronic hemodialysis patients.

详细描述

This is the prospective comparison study. This study enrolled chronic hemodialysis patients age more than 18 who undergo hemodialysis 3 times per week for at least 3 months. All the patients should have serum ferritin 200-1000 ng/L and TSAT of 15-50%. The investigators exclude patients with age more than 70 years, comorbidities influencing citrate metabolism (hepatic failure,liver transplantation,cancer with bone metastasis), patients using heparin free protocol, hyperkalemia worsened by hypocalcemia, contraindication to heparin, treatment with cinacalcet or oral anticoagulant, patients using central venous catheter with blood flow less than 300 ml/min, and patients using low molecular weight heparin.

The study will be conducted in three phases over a period of 4 months. After run-in period for 2 weeks using acetate dialysate, the heparin dose will be titrated to lowest effective dose. During the first phase, citrate was replaced for acetate and heparin will be reduced to 50%. The second and third phase will be performed by reducing heparin doses to 25 % and heparin free consecutively. Each phase lasts for 4 weeks. Washout period for 2 weeks will be alternated after each phase.

Data collection: The investigators measure blood chemistries such as CBC, BUN creatinine electrolytes calcium phosphorus and KT/V at the beginning and at the end of each session. Ionized calcium will be monitored pre and post dialysis in each session. In addition, the investigators record clot score and erythropoietin dosage in each session and each phase.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • This study enrolled chronic hemodialysis patients age more than 18 who undergo hemodialysis 3 times per week for at least 3 months.
  • Serum ferritin 200-1000 ng/L and TSAT of 15-50%.

排除标准

  • age more than 70 years,
  • comorbidities influencing citrate metabolism (hepatic failure,liver transplantation,cancer with bone metastasis),
  • patients using heparin free protocol,hyperkalemia worsened by hypocalcemia
  • contraindication to heparin,
  • treatment with cinacalcet, or oral anticoagulant
  • patients using central venous catheter with blood flow less than 300 ml/min
  • patients using low molecular weight heparin

研究组 & 干预措施

Citrate arm

Experimental

Citrate dialysate Phase 1 : Reduce heparin to 50% Phase 2: Reduce heparin to 25% Phase 3: Heparin free

干预措施: Citrate dialysate (Device)

结局指标

主要结局

Effect of citrate dialysate to anemia

时间窗: 3 months

Hemoglobin in gram per dL

次要结局

  • effect of citrate dialysate to electrolyte changes(3 months)
  • Effect of citrate dialysate to dialyzer clotting(3 months)
  • effect of citrate dialysate to dialysis adequacy(3 months)

研究者

申办方类型
Other Gov
责任方
Principal Investigator
主要研究者

Thananda Trakarnvanich

Associate Professor

Bangkok Metropolitan Administration Medical College and Vajira Hospital

研究点 (2)

Loading locations...

相似试验