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临床试验/NCT03080441
NCT03080441Unknown4 期

Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention

Nimedical0 个研究点目标入组 35 人开始时间: 2016年11月11日最近更新:
适应症
干预措施

试验速览

阶段
4 期
发起方
入组人数
35
主要终点
Hypotension

研究概览

简要总结

This is a research study to test the application of FDA-approved, non-invasive device (NICaS) that measure the performance of your heart during HD treatment.

详细描述

The incidence of intradialytic hypotension (IDH) events, reported to occur in 15% to 50% of hemodialysis (HD) treatments, is still high despite major technical advances in HD technology. By definition, excessive reduction in intravascular volume by ultrafiltration and limited vascular refilling from tissues into the vascular space is the cause of IDH. Chronic HD patients exhibit a high prevalence of peripheral vascular and cardiac abnormalities. Specifically, hemodynamic instability during HD can occur due to insufficient reduction in venous unstressed volume, poor diastolic filling under reduced atrial pressures associated with diastolic dysfunction, altered cardiac contractility, and impaired vascular reactivity. An IDH event can lead to myocardial cerebral and other organ ischemia. Long- and short-term adverse outcomes have been associated with IDH, a common HD complication and significant cause of morbidity.

Recent pilot studies suggest that in IDH-prone subjects, measurements of hemodynamic variables during HD can be used to categorize the hemodynamic response into three subgroups: cardiac power index (CPI) reduction with stable total peripheral resistance (TPR), TPR reduction with stable CPI, and reduction in TPR and CPI groups. It is hypothesized that targeted intervention for each subgroup can reduce IDH.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
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

入选标准

  • 18 years old or older
  • Have been on maintenance hemodialysis at the facility for at least six months
  • Have not had un-excused missed treatments for six months
  • Is symptomatic to HD treatments
  • Males and non-pregnant/non-nursing females, as confirmed via urine pregnancy testing of women of child bearing potential

排除标准

  • Patient refusal
  • Currently on Midodrine at the start of the Phase 1, Observation period
  • Any known contraindications to Midodrine

研究组 & 干预措施

Phase 1 Group 1

Experimental

pressure stockings worn during dialysis treatment

干预措施: pressure stockings (Device)

Phase 1 Group 2

Experimental

Midodrine before dialysis treatment

干预措施: Midodrine (Drug)

Phase 1 Group 3

Experimental

pressure stocking and Midodrine

干预措施: pressure stockings and midodrine (Other)

结局指标

主要结局

Hypotension

时间窗: 6 weeks

Post dialysis BP measured in mm/Hg

Weight

时间窗: 6 weeks

Post dialysis weight measure in kg

Cardiac Index

时间窗: 1 week

Cardiac Index results from NICaS results vs Echocardiogram results measured in L/min/m2

次要结局

未报告次要终点

研究者

发起方
Nimedical
申办方类型
Industry
责任方
Sponsor

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