跳至主要内容
临床试验/NCT00175734
NCT00175734Unknown不适用

Integrated Studies in Vascular Reactivity and Anemia Correction Therapy in Endstage Kidney Disease Patients

University of British Columbia1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2005年8月最近更新:
适应症

试验速览

阶段
不适用
入组人数
80
试验地点
1
主要终点
To determine what hemoglobin level is best for diabetic dialysis patients. Specific parameters: endothelial cell function and related expansile capacity of blood vessels. *Assessed through labs and pulse wave velocity test

研究概览

简要总结

The purpose of this study is to document relevant and related clinical changes associated with different hemoglobin concentrations in diabetic hemodialysis patients.

Hypothesis: The expansile capacity of blood vessels is affected by different hemoglobin concentrations in diabetic hemodialysis patients.

详细描述

Vascular disease is an important cause of morbidity and mortality in patients with chronic kidney disease (CKD), of which a large proportion is diabetic. Diabetics have complex and multiple reasons for vascular disease, and there is accumulating evidence of associated poor endothelial cell function, particularly in those with kidney disease. One important mechanism through which this might occur relates to changes in shear rate and stress resulting from different viscosity levels. Such fluctuations are increasingly recognized to affect endothelial cell function and hence vessel-wall adaptability in both the short and long term.

Little is known of the consequence of different shear effects on endothelial cell function at various hemoglobin levels in kidney disease. There is some evidence to suggest however that, in the presence of micro-vascular disease, a relative anemia, with associated lower viscosity and shear stress, may be of benefit compared to higher hemoglobin levels.

Diabetics account for almost 40% of dialysis patients worldwide, and are the fastest growing component of the epidemic of CKD. Thus, an understanding of optimal treatment targets for anemia therapy, and the impact of different target levels of hemoglobin on vascular wall function is imperative.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Single Group
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

  • Diabetics and non-diabetics on hemodialysis
  • On erythropoietin and iron
  • On a statin

排除标准

  • Uncontrolled blood pressure (BP)
  • Amputations
  • Unstable cardiac function
  • Malignancy
  • Planned operations

结局指标

主要结局

To determine what hemoglobin level is best for diabetic dialysis patients. Specific parameters: endothelial cell function and related expansile capacity of blood vessels. *Assessed through labs and pulse wave velocity test

时间窗: 8-12 months per participant

次要结局

  • Pulse rate, BP, respiratory rate, peripheral oxygen saturation, ECG during 6-min walk-test and Health Related Quality of Life Assessment as measured by questionnaires(8-12 months per participant)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

Loading locations...

相似试验