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临床试验/NCT00237783
NCT00237783终止1 期

Hemodynamic Changes During Dialysate Sodium Individualization in Hemodialysis Patients

Yale University1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2005年10月最近更新:
适应症
干预措施

试验速览

阶段
1 期
状态
终止
入组人数
4
试验地点
1
主要终点
Intradialytic BP change

研究概览

简要总结

Low blood pressure (hypotension) during dialysis afflicts approximately 25% of hemodialysis patients. In this pilot study, we will evaluate the safety and effects of individualizing the sodium concentration in the dialysate according to the patient's own plasma sodium levels. We hypothesize that patients will have less thirst and less weight gain during the intervention leading to easier fluid removal and less episodes of hypotension.

详细描述

Hypertension and intradialytic hypotension are common complications in patients on chronic maintenance hemodialysis (HD). Sodium balance is important in mediating both processes. Recent evidence 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 this project we plan to evaluate the safety and tolerability of sodium individualization in hypotension-prone patients in order to generate pilot data for a larger study in patients with intradialytic hypotension. In this protocol, we will recruit 7 hypotension-prone subjects. We will use an open-label 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 2 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 2 weeks (total study period 7 weeks, 2 weeks baseline, 4 weeks intervention). 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 hemodynamics (cardiac output and systemic vascular resistance), and the frequency and severity of intradialytic symptoms related to hypotension will be collected on HD sessions during the 4 weeks of intervention.

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
None

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

  • Hemodialysis patients with intradialytic hypotension

排除标准

  • Atrial fibrillation
  • Bilateral upper extremity arteriovenous access
  • Average plasma sodium >139

研究组 & 干预措施

standard dialysate sodium (140 mmol/L)

Active Comparator

dialysate sodium (140 mmol/L)

干预措施: dialysate sodium (140 mmol/L) (Drug)

individualized dialysate sodium

Experimental

individualized dialysate sodium (same concentration as the average pre-HD serum sodium during the baseline period)

干预措施: individualized dialysate sodium (Drug)

结局指标

主要结局

Intradialytic BP change

时间窗: from study onset through intervention, week 7

次要结局

  • Intradialytic changes in cardiac output and peripheral vascular resistance(from study onset through intervention, week 7)
  • Interdialytic weight gain change(from study onset through intervention, week 7)
  • Thirst scores(from study onset through intervention, week 7)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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