Minimization of Intradialytic Hypotension Using Cardiography-Guided Intervention
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
- 否
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
pressure stockings worn during dialysis treatment
干预措施: pressure stockings (Device)
Phase 1 Group 2
Midodrine before dialysis treatment
干预措施: Midodrine (Drug)
Phase 1 Group 3
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
