Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Michigan
• Collaborator: Renal Research Institute
• Treatments: Dialysis Solutions

Criteria

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.