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Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis

Primary Purpose

Chronic Kidney Disease, Arrhythmia

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Dialysate Magnesium (Concentration)
Sponsored by
University of Michigan
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Kidney Disease focused on measuring Hemodialysis, Magnesium, Arrhythmia, QTc interval, QT dispersion

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Michigan Dialysis Center
  • University of Michigan Dialysis Center

Outcomes

Primary Outcome Measures

The primary outcome is the difference in QT dispersion between low dialysate magnesium and normal dialysate magnesium
measurement will be the duration of some changes in the EKG.

Secondary Outcome Measures

Full Information

First Posted
October 17, 2005
Last Updated
December 8, 2014
Sponsor
University of Michigan
Collaborators
Renal Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT00242164
Brief Title
Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis
Official Title
Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2005
Overall Recruitment Status
Completed
Study Start Date
November 2005 (undefined)
Primary Completion Date
June 2006 (Actual)
Study Completion Date
November 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Michigan
Collaborators
Renal Research Institute

4. Oversight

5. Study Description

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 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Arrhythmia
Keywords
Hemodialysis, Magnesium, Arrhythmia, QTc interval, QT dispersion

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
25 (Anticipated)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dialysate Magnesium (Concentration)
Primary Outcome Measure Information:
Title
The primary outcome is the difference in QT dispersion between low dialysate magnesium and normal dialysate magnesium
Description
measurement will be the duration of some changes in the EKG.
Time Frame
over one dialysis session

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Panduranga S Rao, MD, DNB, MS
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Michigan Dialysis Center
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
Facility Name
University of Michigan Dialysis Center
City
Livonia
State/Province
Michigan
ZIP/Postal Code
48152
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.med.umich.edu/intmed/nephrology/STAFF/rao_ps1.htm
Description
Dr. Panduranga Rao's University of Michigan webpage

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Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis

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