Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis
NCT ID: NCT00242164
Last Updated: 2014-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE2
25 participants
INTERVENTIONAL
2005-11-30
2006-11-30
Brief Summary
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Detailed Description
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
CROSSOVER
TREATMENT
NONE
Interventions
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Dialysate Magnesium (Concentration)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
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Renal Research Institute
OTHER
University of Michigan
OTHER
Principal Investigators
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Panduranga S Rao, MD, DNB, MS
Role: PRINCIPAL_INVESTIGATOR
University of Michigan
Locations
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University of Michigan Dialysis Center
Ann Arbor, Michigan, United States
University of Michigan Dialysis Center
Livonia, Michigan, United States
Countries
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Related Links
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Dr. Panduranga Rao's University of Michigan webpage
Other Identifiers
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DRDA 05-2076
Identifier Type: -
Identifier Source: org_study_id