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临床试验/NCT00259714
NCT00259714终止1 期

Hemodynamic and Hormonal Responses to Dialysate Sodium Individualization in Hemodialysis Patients

Yale University1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2006年3月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
1 期
状态
终止
入组人数
1
试验地点
1
主要终点
Changes in cardiac output and systemic vascular resistance

研究概览

简要总结

Salt and water excess is an essential mechanism of hypertension. This is particularly relevant to patients with end stage kidney disease (ESKD) on dialysis. We have demonstrated that individualization of the sodium concentration in the dialysate as to match the patient's own serum sodium concentration leads to less thirst, interdialytic weight gain, and better BP control in hypertensive patients. In this study we will evaluate the mechanisms underlying this response by measuring systemic hemodynamics, body volume spaces, and biochemical marker of volume status.

详细描述

Recent evidence from our group shows that individualization of the sodium concentration in the dialysate to match the patient's own serum sodium results in less thirst, less interdialytic weight gain, less HD-related symptoms, and better blood pressure control in hypertensive subjects. In this project we will evaluate the effect of dialysate sodium individualization on systemic hemodynamics, body volume compartments and biochemical markers of volume control in hypertensive hemodialysis patients. We will use a single-blind cross-over design with randomized blocks. After a 3-week baseline period where pre-HD serum sodium will be measured weekly to establish each patient's average serum sodium, subjects will be randomized to 3 weeks on standard dialysate sodium (140 mmol/L) or individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period), then crossed over to the other for another 3 weeks after a 1-week washout period (dialysate Na 140 mmol/L). The remainder of the dialysis prescription, prescribed dry weight and vasoactive drugs will remain unchanged throughout the study. Clinical information, pre/intra/post-HD blood pressure and thirst scores will be measured weekly at the mid-week dialysis session. In addition, we will measure systemic hemodynamics (cardiac output and systemic vascular resistance), bioimpedance measurements of intracellular and extracellular volume, arterial stiffness (aortic augmentation index, aortic pulse wave velocity), interdialytic (44h) ambulatory BP monitoring, and plasma BNP, renin, aldosterone and norepinephrine at baseline and at the end of each block.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Crossover
主要目的
Treatment
盲法
Single (Participant)

入排标准

年龄范围
18 Years 至 90 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ESKD on hemodialysis
  • Hypertension, defined as average pre-HD BP >150/85 mmHg or use of antihypertensive drugs
  • Average pre-HD serum sodium <139 mmol/L

排除标准

  • Intradialytic hypotension
  • Atrial fibrillation or other chronic tachyarrhythmia (due to effects on measuring equipment)
  • Uncontrolled hypertension (average pre-HD BP >200/105 mmHg)
  • Uncontrolled diabetes mellitus (due to problems on interpretation of serum sodium values)
  • Debilitating illness
  • Inability to provide written informed consent

研究组 & 干预措施

standard dialysate sodium

Active Comparator

In the control phase of the study, the prescribed dialysate sodium is 140 mEq/L

干预措施: standard dialysate sodium (Drug)

dialysate sodium individualization

Experimental

.Dialysate sodium level prescribed matches the subject's average pre-dialysis serum sodium ("individualized").

干预措施: dialysate sodium individualization (Drug)

结局指标

主要结局

Changes in cardiac output and systemic vascular resistance

时间窗: 3 weeks

Changes in intracellular and extracellular volume

时间窗: 3 weeks

BP changes on 44-h ABPM

时间窗: 3 weeks

次要结局

  • Changes in augmentation index(3 weeks)
  • Changes in measured biochemical markers(3 weeks)
  • Change in circadian BP profile on 44-h ABPM(3 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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