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Sponsors and Collaborators: |
University of Michigan Renal Research Institute |
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Information provided by: | University of Michigan |
ClinicalTrials.gov Identifier: | NCT00242164 |
The study is being performed to better understand dialysis techniques which keep heart functions stable during dialysis. People on dialysis have a high risk for heart disease and strokes. More information about dialysis techniques that keep hearts stable may help prevent the high risk of cardiovascular disease and death and help to reduce discomfort during dialysis. In this study we are looking at the way that the magnesium in dialysate affects heart function during dialysis. High or low levels of magnesium may change the way hearts beat. We want to know if lowering the amount of magnesium in dialysate will affect the amount of magnesium in blood or change the heart beat.
Condition | Intervention | Phase |
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Hemodialysis Chronic Kidney Disease Arrhythmia |
Drug: Dialysate Magnesium (Concentration) |
Phase II |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Active Control, Crossover Assignment, Efficacy Study |
Official Title: | Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis |
Estimated Enrollment: | 25 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | November 2006 |
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 we plan to study the effect of low levels of magnesium in the dialysate on QT interval and dispersion and the tendency for rhythm change. We will compare QT interval changes 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Kathryn M Lindblad, RN, MBA | 734-764-5187 | lindblad@umich.edu |
United States, Michigan | |
University of Michigan Dialysis Center | |
Ann Arbor, Michigan, United States, 48104 | |
University of Michigan Dialysis Center | |
Livonia, Michigan, United States, 48152 |
Principal Investigator: | Panduranga S Rao, MD, DNB, MS | University of Michigan |
Study ID Numbers: | DRDA 05-2076 |
Study First Received: | October 17, 2005 |
Last Updated: | October 17, 2005 |
ClinicalTrials.gov Identifier: | NCT00242164 History of Changes |
Health Authority: | United States: Institutional Review Board |
Hemodialysis Magnesium Arrhythmia QTc interval QT dispersion |
Renal Insufficiency Heart Diseases Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Kidney Diseases Kidney Failure Arrhythmias, Cardiac |
Renal Insufficiency Pathologic Processes Heart Diseases Urologic Diseases Renal Insufficiency, Chronic |
Kidney Failure, Chronic Cardiovascular Diseases Kidney Diseases Kidney Failure Arrhythmias, Cardiac |