Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis
研究概览
详细说明
Heart disease is a major cause of illness and death among patients on dialysis. Changes in the heart's rhythm and sudden cardiac death are also important problems in this group. Abnormal rhythm can occur during hemodialysis.
During dialysis, the blood comes in contact with a solution called dialysate. This solution contains minerals like calcium, potassium and magnesium. Some studies have indirectly suggested that lower magnesium in dialysis patients protects them from having rhythm problems.
Factors that increase the chance for the development of abnormal rhythms can be indirectly assessed by evaluating the electrocardiogram (EKG). This is done by measuring the distance between the wave forms on the EKG. One of these is called the QT interval. QT dispersion is a value derived from the QT interval. A long QT interval is thought to make an individual more prone to having abnormal heart rhythms.
Therefore it is planned to study the effect of low levels of magnesium in the dialysate on QT interval and dispersion and the tendency for rhythm change. QT interval changes will be compared during dialysis with low magnesium with QT interval changes during dialysis with normal magnesium.
This will be a cross over trial including 24 adult male and female patients on chronic hemodialysis. Subjects will be studied during two of their regular dialysis sessions, the only difference being the amount of magnesium in the dialysate. QT interval and QT dispersion will be calculated from the EKG recordings before and after each dialysis session.
The results of this study will lead to a better understanding of cardiovascular risks in patients undergoing chronic dialysis and may offer a potentially novel strategy to reduce the risk of abnormal heart rhythms risk during dialysis.
研究类型
注册 (预期的)
阶段
- 阶段2
联系人和位置
学习地点
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Michigan
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Ann Arbor、Michigan、美国、48104
- University of Michigan Dialysis Center
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Livonia、Michigan、美国、48152
- University of Michigan Dialysis Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- 18 years of age and over with end-stage renal disease. (ESRD)
- have been on maintenance hemodialysis therapy three times/week for greater than or equal to 3 months
- All causes of renal failure are included
Exclusion Criteria:
- less than 18 years of age
- have been on maintenance hemodialysis therapy three times/week for less than 3 months
- are pregnant or lactating
- unable or unwilling to provide informed consent
- currently participating in a clinical trial with an intervention
- systolic (top number) blood pressure levels greater than or equal to 180 or less then 80
- diastolic (bottom number) blood pressure levels greater than 110
- a hemoglobin level (red blood cell measure) that is less than 8mg/dl
- a corrected calcium level that is greater than 11mg/dl or less than 8mg/dl
- had a change in their anti-hypertensive medications within the last three weeks
- clinical signs and symptoms of untreated or unresolved infection
- clinical evidence requiring admission to the hospital
- had a cerebral vascular accident or myocardial incident within the past 3 months
- Based on the assessment of the investigators, or study coordinator designee, patients who appear unlikely or unable to participate in the required study procedures
- Patients with a history of arrhythmias, recent electrophysiological evaluation and or having pacemakers are excluded.
- Patients with acute renal failure.
学习计划
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：非随机化
- 介入模型：交叉作业
- 屏蔽：无（打开标签）
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The primary outcome is the difference in QT dispersion between low dialysate magnesium and normal dialysate magnesium
大体时间：over one dialysis session
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measurement will be the duration of some changes in the EKG.
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over one dialysis session
|
合作者和调查者
调查人员
- 首席研究员：Panduranga S Rao, MD, DNB, MS、University of Michigan
出版物和有用的链接
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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