Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2005 by University of Michigan.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Renal Research Institute
Information provided by:
University of Michigan
ClinicalTrials.gov Identifier:
NCT00242164
First received: October 17, 2005
Last updated: June 24, 2010
Last verified: July 2005
  Purpose

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.


Condition Intervention Phase
Hemodialysis
Chronic Kidney Disease
Arrhythmia
Drug: Dialysate Magnesium (Concentration)
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis

Resource links provided by NLM:


Further study details as provided by University of Michigan:

Primary Outcome Measures:
  • The primary outcome is the difference in QT dispersion between low dialysate magnesium and normal dialysate magnesium

Estimated Enrollment: 25
Study Start Date: November 2005
Estimated Study Completion Date: November 2006
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 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00242164

Contacts
Contact: Kathryn M Lindblad, RN, MBA 734-764-5187 lindblad@umich.edu

Locations
United States, Michigan
University of Michigan Dialysis Center Not yet recruiting
Ann Arbor, Michigan, United States, 48104
Contact: Linda Haiju, RN    734-677-1490      
Principal Investigator: Panduranga S Rao, MD, DNB, MS         
University of Michigan Dialysis Center Not yet recruiting
Livonia, Michigan, United States, 48152
Contact: Therese Adamowski, RN    734-432-7870      
Principal Investigator: Panduranga S Rao, MD, DNB, MS         
Sponsors and Collaborators
University of Michigan
Renal Research Institute
Investigators
Principal Investigator: Panduranga S Rao, MD, DNB, MS University of Michigan
  More Information

Additional Information:
No publications provided

ClinicalTrials.gov Identifier: NCT00242164     History of Changes
Other Study ID Numbers: DRDA 05-2076
Study First Received: October 17, 2005
Last Updated: June 24, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by University of Michigan:
Hemodialysis
Magnesium
Arrhythmia
QTc interval
QT dispersion

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Kidney Diseases
Renal Insufficiency, Chronic
Kidney Failure, Chronic
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Urologic Diseases
Renal Insufficiency

ClinicalTrials.gov processed this record on July 23, 2014