Ignite Creation Date:
2024-05-05 @ 12:06 PM
Last Modification Date:
2024-10-26 @ 9:20 AM
Study NCT ID:
NCT00242164
Status:
COMPLETED
Last Update Posted:
2014-12-09
First Post:
2005-10-17
Brief Title:
Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis
Sponsor:
University of Michigan
Organization:
University of Michigan
Study Overview
Official Title:
Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis
Status:
COMPLETED
Status Verified Date:
2005-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 This study will look 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 The question asked is if lowering the amount of magnesium in dialysate will affect the amount of magnesium in blood or change the heart beat
Detailed Description:
Heart disease is a major cause of illness and death among patients on dialysis Changes in the hearts 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None