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临床试验/NCT02719223
NCT02719223已完成不适用

The Effect of On-Line Hemodiafiltration Versus High Flux Hemodialysis on Hemodynamic Parameters in Patients With Intra-Dialytic Hypotension

Western Galilee Hospital-Nahariya2 个研究点 分布在 1 个国家目标入组 20 人开始时间: 2017年1月最近更新:
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
20
试验地点
2
主要终点
Total peripheral resistance (dynes/sec/cm5)

研究概览

简要总结

Rationale and objectives

  1. Patients on On Line Hemodiafiltration (OL- HDF) are more stable hemodynamically with less Intra Dialytic Hypotension (IDH) episodes compared to conventional hemodialysis (HD). The investigator will follow the hemodynamic parameters during the dialysis sessions (HD and OL-HDF) by using the new non invasive technology, the NICAS device.
  2. By switching each patient with IDH from HD to OL- HDF, the investigators will evaluate the hemodynamic parameters and compare the two renal replacement treatment modalities, and prove the superiority of OL-HDF over HD regarding the hemodynamic measures.

详细描述

Intradialytic hypotension (IDH) or a significant fall in blood pressure (BP) is the most common complication that occurs during hemodialysis (HD) treatment, occurring in up to 20-33% of sessions.

Different mechanisms are involved in the pathogenesis of IDH including acute central hypovolemia, may be precipitated by rapid or excessive ultrafiltration that lead to intravascular volume depletion beyond the level of hemodynamic compensatory response. Other proposed mechanisms of intra vascular depletion are volume shift into the extra-vascular space due to rapid reduction in plasma osmolality, slow and incompatible vascular refilling rate and incorrectly low prescribed dry weight.

Autonomic dysfunction occurs in considerable amount of dialysis patients up to about 50% . This dysfunction reduces the ability to produce an adequate sympathetic response in the setting of acute volume diminution.

Due to the complexity of the dialysis treatment and absence of non- invasive technology, few studies followed the hemodynamic changes which occur during a dialysis session especially during IDH episodes.

OL- HDF is a relatively new method of therapy that allows a larger volume of blood filtration during a single dialysis therapy compared with standard hemodialysis.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Crossover
主要目的
Diagnostic
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

入选标准

  • Patients affected by IDH during one or more dialytic sessions every week

排除标准

  • Patients with recent change in chronic medications, chronic liver disease, recent acute coronary event, cardiac arrhythmias and acute infection.

研究组 & 干预措施

High Flux Hemodialysis

Experimental

干预措施: NICaS (Device)

OL-HDF

Experimental

干预措施: NICaS (Device)

结局指标

主要结局

Total peripheral resistance (dynes/sec/cm5)

时间窗: 5 weeks

The superiority of OL-HDF over regular hemodialysis in decreasing the frequency of intradialytic hypertension episodes.

时间窗: 5 weeks

Mean arterial pressure (mm/Hg)

时间窗: 5 weeks

Cardiac index (l/min/m2)

时间窗: 5 weeks

次要结局

未报告次要终点

研究者

申办方类型
Other Gov
责任方
Sponsor

研究点 (2)

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