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临床试验/NCT01947673
NCT01947673已完成不适用

Sympathetic Regulation in Intradialytic Hypertension

Emory University2 个研究点 分布在 1 个国家目标入组 49 人开始时间: 2013年9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
49
试验地点
2
主要终点
Cardiopulmonary baroreflex Sensitivity

研究概览

简要总结

Patients with end-stage renal disease (ESRD) are at significantly higher risk for death due to cardiovascular disease. Those with paradoxical increases in blood pressure (BP) during hemodialysis (HD), defined as intradialytic hypertension (IDH), are at even greater risk of cardiovascular mortality. This study seeks to determine the mechanisms that underlie IDH, and whether mindfulness meditation might improve BP during dialysis in these patients. The investigators will first determine if increased adrenaline levels during volume removal contributes to IDH. The investigators will then determine lack of suppression of adrenaline levels in the setting of a high BP also contributes to IDH. This will be done by manipulating blood pressure by using small amounts of vasoactive drugs, and determining if an appropriate response in adrenaline levels occurs. Lastly, the investigators will determine if an intradialytic mindfulness meditation program improves BP and adrenaline levels in ESRD patients with IDH.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Other
盲法
None

入排标准

年龄范围
18 Years 至 80 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • ESRD patients on maintenance hemodialysis for at least 6 months, with increased blood pressure during hemodialysis

排除标准

  • drug or alcohol abuse
  • any serious systemic disease that might influence survival
  • severe anemia with hgb level <8 g/dL
  • clinical evidence of congestive heart failure
  • ejection fraction below 35%
  • myocardial infarction or cerebrovascular accident within the past six months
  • symptomatic heart disease determined by electrocardiogram, stress test, and/or history
  • treatment with central alpha agonists or monoamine oxidase (MAO) inhibitors
  • peripheral neuropathy
  • autonomic dysfunction
  • pregnancy
  • surgery within the past 3 months

结局指标

主要结局

Cardiopulmonary baroreflex Sensitivity

时间窗: 8 weeks

Blood Pressure during dialysis

时间窗: 8 weeks

次要结局

  • Kidney Disease Quality of Life (KDQOL) Symptom Score(8 weeks)

研究者

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

Jeanie Park

Assistant Professor

Emory University

研究点 (2)

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