Defining The Role Of Dialysate Magnesium In Arrhythmogenicity On Dialysis

Status Completed

Clinical 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. 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.

Clinical Trial 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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT00242164
Study type	Interventional
Source	University of Michigan
Contact
Status	Completed
Phase	Phase 2
Start date	November 2005
Completion date	November 2006

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05491642` - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses	Phase 1
Recruiting	`NCT06363097` - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Terminated	`NCT04043026` - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Completed	`NCT05318014` - Low-protein Formula Supplements in Chronic Kidney Disease	N/A
Active, not recruiting	`NCT06071065` - Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients	N/A
Completed	`NCT02878317` - Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
Not yet recruiting	`NCT06039254` - Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function	Phase 1
Recruiting	`NCT03160326` - The QUALITY Vets Project: Muscle Quality and Kidney Disease
Completed	`NCT02888171` - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency	N/A
Completed	`NCT02756520` - Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
Completed	`NCT02836574` - A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease	Phase 2
Completed	`NCT02896309` - The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity	N/A
Completed	`NCT02875886` - DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease	Phase 4
Withdrawn	`NCT02885545` - The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial	Phase 4
Active, not recruiting	`NCT02483039` - Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization	N/A
Terminated	`NCT02543177` - Optimised Procedure in Patients With NSTEMI and CKD	N/A
Completed	`NCT02369549` - Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease	Phase 3
Completed	`NCT02992548` - Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease	Phase 4
Recruiting	`NCT02205944` - Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes	N/A
Active, not recruiting	`NCT02231138` - Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease	Phase 4