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临床试验/NCT05188339
NCT05188339Unknown2 期

Compare Effectiveness and Safety Utilizing 4% Sodium Citrate vs. Heparin as a Lock Solution in Central Venous Hemodialysis Catheter Among Hemodialysis Patients

Chang Gung Memorial Hospital1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2022年7月20日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
2 期
发起方
入组人数
120
试验地点
1
主要终点
central venous catheter exchanges

研究概览

简要总结

Studies that used a dilute citrate formulation (4%) demonstrated efficacy as an anticoagulant with minimal to no risk of bleeding in HD sessions. This study will compare effectiveness and safety utilizing 4% sodium citrate vs. heparin as a lock solution in central venous hemodialysis catheter among hemodialysis patients.

详细描述

Vascular access is necessary for hemodialysis(HD) procedure. In normal situation, vascular access for HD is created in peripheral vessels. However, vascular catheter may be considered in patients without available peripheral vessels for vascular access. The characteristic of these patients include elderly, diabetes, not tolerant to vascular surgery etc.. Commonly, the HD catheter is inserted in the central vein in these population. Considering clotting condition, anticoagulant is indicated for catheter locking after HD session. In the past years, heparin is the most common solution to be used as locking solution. Nevertheless, heparin has a few disadvantages, such as systemic anticoagulation, thrombocytopenia, and bleeding risk. An alternative for anticoagulation in HD session is 4% sodium citrate. The effectiveness and safety of sodium citrate in HD sessions have been reported in clinical studies.

Characteristics of sodium citrate and safety profile Trisodium citrate acts locally as an anticoagulant by chelating ionized calcium in blood, resulting in the blockage of calcium-dependent clotting pathways. Studies that used a dilute citrate formulation (4%) demonstrated efficacy as an anticoagulant with minimal to no risk of bleeding in HD sessions. The advantageous effects of sodium citrate in HD catheter locking solution includes reducing frequency of catheter exchanges, reducing using of thrombolytic drugs, reducing hospitalization rates, and bacteremia. Regarding adverse effect of sodium citrate, hypocalcemia and other untoward outcomes are rare reported in the previous clinical studies

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Prevention
盲法
None

入排标准

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

入选标准

  • Age >=20 years
  • End-stage renal disease patients who received regular HD weekly via central venous catheter for at least 3 months in outpatient clinic in Kaohsiung Chang Gung Memorial Hospital, Taiwan

排除标准

  • bleeding tendency
  • on radiotherapy or chemotherapy for malignancy
  • drug allergy history to citrate
  • undefined reasons for refuted participation.

研究组 & 干预措施

4% sodium citrate group

Experimental

Dose of 4% sodium citrate is also according to catheter lumen (LVR) instilled into each lumen of catheter after HD session, eg. 1.6 cc/lumen for LV R 1.6, 1.8 cc/lumen for LVR 1.8.

干预措施: 4% sodium citrate (Drug)

heparin group

Active Comparator

Heparin dosage is based on volume ratio in catheter lumen (LVR) after each HD session, eg. 8000u/lumen in 1.6 LVR, 9000u/lumen in LVR 1.8.

干预措施: heparin group (Drug)

结局指标

主要结局

central venous catheter exchanges

时间窗: 3 months

We will record the episode of central venous catheter malfunction and central venous catheter exchanges within the period of trial and compare the incidence between two arms.

次要结局

  • events of thrombolytic drug use, bacteremia and all-cause hospitalization days.(3 months)

研究者

发起方
Chang Gung Memorial Hospital
申办方类型
Other
责任方
Sponsor

研究点 (1)

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