Status:
COMPLETED
Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis
Lead Sponsor:
University of Michigan
Collaborating Sponsors:
Renal Research Institute
Conditions:
Chronic Kidney Disease
Arrhythmia
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 informa...
Detailed Description
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 oc...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 1 2006
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00242164
Start Date
November 1 2005
End Date
November 1 2006
Last Update
December 9 2014
Active Locations (2)
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1
University of Michigan Dialysis Center
Ann Arbor, Michigan, United States, 48104
2
University of Michigan Dialysis Center
Livonia, Michigan, United States, 48152