Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis
Recruitment status was Not yet recruiting
|First Received Date ICMJE||October 17, 2005|
|Last Updated Date||June 24, 2010|
|Start Date ICMJE||November 2005|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||The primary outcome is the difference in QT dispersion between low dialysate magnesium and normal dialysate magnesium|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00242164 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE||Not Provided|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis|
|Official Title ICMJE||Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
|Intervention ICMJE||Drug: Dialysate Magnesium (Concentration)|
|Study Arm (s)||Not Provided|
|Publications *||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Not yet recruiting|
|Estimated Enrollment ICMJE||25|
|Estimated Completion Date||November 2006|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
|Ages||18 Years and older|
|Accepts Healthy Volunteers||No|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00242164|
|Other Study ID Numbers ICMJE||DRDA 05-2076|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||University of Michigan|
|Collaborators ICMJE||Renal Research Institute|
|Information Provided By||University of Michigan|
|Verification Date||July 2005|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP