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临床试验/NCT03038165
NCT03038165已完成不适用

Hemodynamic Parameters Changes in the Course of Hemodialysis Sessions in Patients With Intradialytic Hypertension

Western Galilee Hospital-Nahariya1 个研究点 分布在 1 个国家目标入组 22 人开始时间: 2016年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
22
试验地点
1
主要终点
Cardiac index (l/min/m2)

研究概览

简要总结

While the exact pathogenesis of Intradialytic hypertension remains to be determined, several mechanisms were proposed to be involved. The main factors to determine the arterial blood pressure are the peripheral vascular resistance and cardiac output. The assumption is that the increase of blood pressure is related to the increase in peripheral vascular resistance during the dialysis session, due to fluid removal and fast reduction of the intravascular volume reduction.

Using the NICAS device (Non-Invasive Cardiac System), the hemodynamic profile in patients with intradialytic hypertension will be evaluated

详细描述

The number of patients with end stage renal disease (ESRD) is growing worldwide and nowadays hemodialysis (HD) treatment is the prevalent modality of renal replacement therapy. Paradoxically an increase of BP during or immediately after the HD sessions has been observed in some patients. This phenomenon is referred to as Intradialytic Hypertension (IDH). The focus will be on systolic BP increase ≥ 10 mmHg during or immediately after hemodialysis which results in post-dialysis hypertension BP above ≥130/80 mmHg. IDH affects up to 10-15% of hemodialysis patients. Patients with IDH have unfavorable outcomes; previous epidemiological data showed that IDH is associated with higher cardiovascular morbidity and mortality rates.

From the view of hemodynamic profile, peripheral resistance and cardiac output are the most important factors contributing to arterial blood pressure. The pathogenesis of IDH is likely to be multifactorial. Several mechanisms were proposed to be involved in the pathogenesis of this phenomenon.

Endothelial dysfunction, increased activity of the renin angiotensin aldosterone system (RAAS) and activation of the sympathetic nervous system had been shown to be involved in the increase of blood pressure during Hemodialysis in this group of patients.

None of these possible explanations or their inter-relationships has been studied in a controlled experimental setting and the actual physiological changes during hemodialysis in intradialytic hypertensive patients still remain unexplored.

The NICAS (Non-Invasive Cardiac System) device, used mainly for noninvasive cardiac diagnostic purposes, is substantially equivalent to the use of other hemodynamic evaluation tools, yet it is non-invasive and provides on-line data regarding the hemodynamic status of patients. Using this device, the hemodynamic changes during the HD session of IDH patients will be investigated.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

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

  • Intradialytic hypertension at least once weakly
  • Age older than 18 years
  • Chronic hemodialysis treatment more than 3 months
  • Stable dialysis treatment conditions
  • Stable antihypertensive treatment for the last 4 weeks prior the study
  • Patients able and agree to sign the consent form.

排除标准

  • Recent changes in the antihypertensive treatment
  • Recent acute cardiovascular event

结局指标

主要结局

Cardiac index (l/min/m2)

时间窗: During 3 consecutive hemodialysis session in one week

In patients with intradialytic hypertension

Peripheral vascular resistance (dyne/sec/cm5)

时间窗: During 3 consecutive hemodialysis session in one week

In patients with intradialytic hypertension

blood pressure (mm/Hg)

时间窗: During 3 consecutive hemodialysis session in one week

In patients with intradialytic hypertension

Stroke volume (ml)

时间窗: During 3 consecutive hemodialysis session in one week

In patients with intradialytic hypertension

Stroke index (ml/m2)

时间窗: During 3 consecutive hemodialysis session in one week

In patients with intradialytic hypertension

Cardiac output (l/min)

时间窗: During 3 consecutive hemodialysis session in one week

In patients with intradialytic hypertension

Heart rate (bpm)

时间窗: During 3 consecutive hemodialysis session in one week

In patients with intradialytic hypertension

次要结局

未报告次要终点

研究者

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

Khaled Khazim, MD

Principle investigator

Western Galilee Hospital-Nahariya

研究点 (1)

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