Chronic Kidney DiseasePhase 2NCT00242164
Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis
A Phase 2 study testing Dialysate Magnesium (Concentration) in people with Chronic Kidney Disease and Arrhythmia, run by University of Michigan at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease, Arrhythmia
- What is being tested?
- Dialysate Magnesium (Concentration)
- How many people
- 25 participants
- Where
- 2 sitesUnited States
- Study dates
- Nov 2005to Nov 2006
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of Michigan Dialysis Center
Ann Arbor, Michigan, 48104
University of Michigan Dialysis Center
Livonia, Michigan, 48152
About this study
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.
Read the 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.
- Conditions
- Chronic Kidney Disease, Arrhythmia
- Being tested
- Dialysate Magnesium (Concentration)
- Keywords
- Hemodialysis, Magnesium, Arrhythmia, QTc interval, QT dispersion
- Medical subject headings
- Renal Insufficiency, Chronic, Arrhythmias, Cardiac
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dialysate Magnesium (Concentration)Drug
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: over one dialysis session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2005 (estimated)
- Study startNov 2005
- Primary completionJun 2006
- Study completionNov 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University of MichiganThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Renal Research Institute
- Investigators
- Panduranga S Rao, MD, DNB, MS, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00242164
- Sponsor's protocol ID
- DRDA 05-2076
- Status last verified
- Jul 2005
- First submitted
- 17 Oct 2005
- Last updated
- 9 Dec 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis
- ClinicalTrials.gov ID
- NCT00242164
- Acronym / sponsor ID
- DRDA 05-2076
- Conditions
- Chronic Kidney Disease, Arrhythmia
- Keywords
- Hemodialysis, Magnesium, Arrhythmia, QTc interval, QT dispersion
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Renal Research Institute
- Study start
- Nov 2005
- Primary completion
- Jun 2006 (actual)
- Study completion
- Nov 2006 (actual)
- First posted
- 19 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dialysate Magnesium (Concentration) | Drug | – |
Primary outcome
The primary outcome is the difference in QT dispersion between low dialysate magnesium and normal dialysate magnesium
Time frame: over one dialysis session
measurement will be the duration of some changes in the EKG.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2014.
- Dr. Panduranga Rao's University of Michigan webpageLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Panduranga S Rao, MD, DNB, MS principal investigator
University of Michigan
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dialysate Magnesium (Concentration) in people with Chronic Kidney Disease and Arrhythmia, run by University of Michigan at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is the difference in QT dispersion between low dialysate magnesium and normal dialysate magnesium (time frame: over one dialysis session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2014.